Mukhtar2021 - Hands Off

Review
Evaluation & the Health Professions

1-21
Effectiveness of Hands-Off Therapy in the ª The Author(s) 2021
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Management of Primary Headache: DOI: 10.1177/0163278720983408
journals.sagepub.com/home/ehp
A Systematic Review and Meta-Analysis
Naziru Bashir Mukhtar1,2 , Mira Meeus1,3,4, Ceren Gursen5, Jibril Mohammed2,

Robby De Pauw1, and Barbara Cagnie1
Abstract
A number of hands-off therapies have been widely reported and are used in the management of headache. This systematic review
and meta-analysis aimed to assess evidence supporting these therapies on selected headache outcomes. A systematic literature
search for randomized clinical trials reporting on the effects of hands-off therapies for headache was performed in two electronic
databases; PubMed and Web of Science (PROSPERO: CRD42018093559). Risk of bias was assessed using the Cochrane risk of
bias tool. Meta-analysis was performed using Review Manager v5.4. Thirty-five studies, including 3,403 patients with migraine,
tension-type or chronic headaches were included in the review. Methodological quality of the studies ranged from poor to good.
Result-synthesis revealed moderate evidence for aerobic exercises, relaxation training and pain education for reducing pain
intensity and disability. Other hands-off interventions were either weak or limited in evidence. Meta-analysis of 22 studies
indicated that the effect of hands-off therapies significantly differed from one another for pain intensity, disability and quality of life
(p ⬍ 0.05). Relaxation training, aerobic and active/stretching exercises had significant effect on pain intensity and disability
(p ⬍ 0.05). To conclude, few hands-off therapies were effective on selected headache outcomes. Evidence to support other
hands-off therapies is limited by paucity of studies.
Keywords
effectiveness, hands-off, therapy, headache, trials
Background Roth, 2015). The treatment approaches of headache mainly

include pharmacological/drug-therapy (Evers et al., 2009) and
Headache is a major public health problem (Molarius &
non-pharmacological treatments. Additionally, most of the
Tegelberg, 2006; Saylor & Steiner, 2018; Stovner et al.,
non-pharmacological therapies used for headache can appro-
2006), with impact on both patients and society (Rasmussen,
priately fit into either a hands-on or hands-off therapy. Hands-
1999; Seddik et al., 2020). Throughout the world, people who
on therapy involves the use of manual contact by the therapist
are affected by headache and professionals working in the
(Jull & Moore, 2012; Pierce-Williams et al., 2019), whereas
field of headache know that these disorders often continue
hands-off therapy involves giving instructions, guidance, self-
lifelong (Saylor & Steiner, 2018; Steiner, 2005). Headache
administered treatment, all lacking a direct patient-therapist
is classified as either primary headache, which refers to per-
physical contact (Jull & Moore, 2012). Hands-off therapies
sistent head pain without any underlying cause, this includes
include psychological treatment, biofeedback therapy, beha-
migraine, tension type headache, cluster headache and
vioral and cognitive therapy, patient education (Andersson
chronic headache (Dodick, 2003; Stovner et al., 2006), or
secondary headache, which results from trauma or another
underlying systemic disorder or medical cause (Benoliel 1
Department of Rehabilitation Sciences, Ghent University, Belgium
2
et al., 2019; Dodick, 2003). The global prevalence of three Department of Physiotherapy, Bayero University Kano, Nigeria
3
common types of headaches; migraine, tension type headache Pain in Motion International Research group, Belgium
4
Department of Rehabilitation Sciences and Physiotherapy, University of
and chronic daily headache, is estimated at 10%, 38% and 3%, Antwerp, Belgium
respectively (Jensen & Stovner, 2008). 5
Department of Physiotherapy and Rehabilitation, Hacettepe University,
To achieve high quality care and reduction of cost burden, Turkey
correct treatment is important in the management of headache.
Corresponding Author:
However, effective long-term management can be challenging,
Naziru Bashir Mukhtar, Department of Rehabilitation Sciences, Ghent Uni-
because these disorders are complex and often present with versity, Corneel Heymanslaan 10, 9000 Ghent, Belgium.
heterogeneous triggers, expression and impact (Rathier & Emails: nazirubashir.mukhtar@ugent.be; nbmukhtar.pth@buk.edu.ng
2 Evaluation & the Health Professions XX(X)
et al., 2003) and physical training (Ylinen et al., 2010), etc. Table 1. Search Strategy used in the PubMed and Web of Science
while hands-on therapies include acupuncture, manipulation Databases.
and massage etc. (Castien et al., 2009; Torelli et al., 2004). PubMed
The improvement of biopsychosocial model and modern neu-
roscience approach in the management of chronic pain has led 1 “headache”[MeSH Terms] OR headache[TIAB] OR “head
to increased use of hands-off treatments (Gaul et al., 2009). pain”[TIAB] OR “cephalgia”[TIAB] OR “migraine
Although patients often wish to have a physical treatment con- disorders”[MeSH Terms] OR “migraine”[TIAB]
2 “hands off therapy”[TIAB] OR “hands off treatment”[TIAB] OR
tact with therapists (Bishop et al., 2011; Lurie et al., 2008;
“pain education”[TIAB] OR “neuroscience education”[TIAB]
Verbeek et al., 2004), evidence on the effectiveness, the OR “pain neuroscience education”[TIAB] OR “exercise
increase in self-efficacy and the affordability of these hands- therapy”[TIAB] OR “stretching”[TIAB] OR “relaxation”[TIAB]
off interventions may be more important in decision making. OR “ergonomics”[TIAB] OR “graded activity”[TIAB] OR
Furthermore, considering the enormous burden of headache on “graded exposure”[TIAB] OR “Cognitive Therapy”[Mesh] OR
patients, their jobs, social and family life, as well as on the cognitive psychotherap*[TIAB] OR cognitive therap*[TIAB] OR
health care system and insurance companies, it is important cognition therap*[TIAB] OR cognitive behavior therap*[TIAB]
OR “motor control”[TIAB] OR “movement control”[TIAB] OR
to investigate the effectiveness of alternative therapies that
“body movement therap*”[TIAB] OR “meditation”[TIAB] OR
require less hospital visits, less dependency and improve pro- “mindfulness”[TIAB]
ductivity. Previous reviews have investigated the effectiveness 3 “pain”[MeSH Terms] OR pain[TIAB] OR “disability”[TIAB] OR
of non-pharmacological therapies (self-management) for head- “Quality of Life”[Mesh] OR life qualit*[TIAB] OR “quality of
ache (without physical therapy, exercises and biofeedback) life”[TIAB] OR life qualit*[TIAB] OR living qualit*[TIAB] OR
(Probyn et al., 2017) and the effects of interventions that are “quality of living”[TIAB] OR “Activities of Daily Living”[Mesh]
a mix of hands-on and hands-off therapies (Baillie et al., 2014; OR “activities of daily living”[TIAB] OR “activity of daily
living”[TIAB] OR “activities of daily life”[TIAB] OR “activity of
Biondi, 2005; Luedtke et al., 2016). However, to our knowl-
daily life”[TIAB] OR daily living activit*[TIAB] OR daily life
edge, no systematic review has investigated the effect of hands- activit*[TIAB] OR “adl”[TIAB] OR “chronic limitation of
off therapies in the management of headache. Therefore, the activity”[TIAB] OR self care*[TIAB] OR “Health Status”[Mesh]
aim of the present systematic review (SR) is to summarize the OR “health status”[TIAB] OR “level of health”[TIAB] OR health
evidence for the effectiveness of hands-off therapy on pain level*[TIAB] OR “qol”[TIAB] OR “hrql”[TIAB] OR
intensity and disability, quality of life, and sleep quality in the “hrqol”[TIAB] OR “sleep”[MeSH Terms] OR “sleep”[TIAB]
management of headache based on the results of existing ran- AND “quality”[TIAB]
4 1 AND 2 AND 3
domized clinical trials (RCTs).
Web of Science
1 TS¼(“headache” OR “head pain” OR “cephalgia” OR “migraine”)
2 TS¼(“hands off therapy” OR “hands off treatment” OR “pain
Methods education” OR “neuroscience education” OR “pain
The present SR is reported in accordance with the Preferred neuroscience education” OR “exercise therapy” OR
“stretching” OR “relaxation” OR “ergonomics” OR “graded
Reporting Items for Systematic reviews and Meta-Analyses
activity” OR “graded exposure” OR “cognitive behavioural
(PRISMA) guideline (Moher et al., 2009). In addition, the therapy” OR “cognitive behavioral therapy” OR “motor
review protocol was pre-registered in PROSPERO control” OR “movement control” OR “body movement
(CRD42018093559) prior to starting the literature search. The therapy” OR “meditation” OR “mindfulness”)
research question of the SR was determined using the PICOS 3 TS¼(“pain” OR “disability” OR “quality of life” OR “sleep quality”)
approach: what is the effectiveness of hands-off therapy (I ¼ 4 1 AND 2 AND 3
intervention) on pain intensity, disability, quality of life and
sleep quality (O ¼ outcome) in patients suffering from pri-
mary headache (migraine, tension type headache and chronic
headache) (P ¼ population) when compared to controls (C ¼ the data search (Falagas et al., 2008). Web of Science was also
comparison) in RCT’s (S ¼ study design). The focus of this searched for its multidisciplinary nature and strong coverage
review was on studies in which patients with headache were (Aghaei Chadegani et al., 2013). We consider the coverage of
managed with interventions that were either self-administered the two databases sufficient as they mostly cover fields of other
by the patients or do not require physical contact between the specialized databases.
therapist and the patients. The database search was carried in July 2018, and later
updated on the 27th January 2020. In both instances, the refer-
ence list of the potentially relevant studies was screened to
Information Sources and Search Strategy make the review as complete as possible.
To identify relevant articles, the online databases of PubMed
(1966 to 2020) and Web of Science (1955 to 2020) were
searched for published articles using a search strategy that was
Eligibility Criteria
created based on the PICOS approach (Table 1). PubMed being To be included in this review, studies had to meet these criteria:
an optimal tool in biomedical electronic research was used for 1) adults (18 years) with any of headache, migraine,
Mukhtar et al. 3
cephalgia or head pain, 2) studies that included assessment of Slavin-Spenny et al., 2013; E. Söderberg et al., 2006;
effectiveness of ‘hands-off therapy’ (including pain education, Sorbi et al., 2015); and
neuroscience education, exercise therapy, stretching, relaxa- iii. Thirteen studies were found to be of poor methodolo-
tion, ergonomics, graded activity, graded exposure, cognitive gical quality (Abbott et al., 2007; Abdoli et al., 2012;
behavioral therapy, exercise, aerobics, yoga, motor control, Bakhshani et al., 2015; Devineni & Blanchard, 2005;
movement control, body movement therapy, sauna, mindful- Dittrich et al., 2008; Holroyd et al., 2001; Khazraee
ness and meditation), 3) evaluation of pain intensity, disability, et al., 2018; Lockett & Campbell, 1992; McGrady
QoL and sleep quality, and 4) available full-text RCTs in Eng- et al., 1994; Narin et al., 2003; Peres et al., 2019;
lish. The focus of the review is on effectiveness of interven- Rashid-Tavalai et al., 2015; Tavallaei et al., 2018).
tions, therefore only RCTs were included in the review.
Most of the poor quality studies did not have sufficient
information (unclear risk) concerning random sequence gener-
Study Selection ation, allocation concealment and blinding (participants/out-
The screening consisted of two phases. Firstly, the articles were comes assessment) (Figure 1).
screened based on titles and abstracts (eligibility criteria
derived from the PICOS question). In the second screening, Data Extraction
the full-text reports of articles that were considered potentially From all the included studies, the two assessors (NBM and JM)
eligible and relevant were retrieved. The assessors indepen- independently extracted and harmonized information on popu-
dently performed both the eligibility assessment and the eva- lation, study country, age range/mean, study groups, nature of
luations. Conflicts were later discussed via a physical meeting intervention/control, outcomes/measures and results.
to obtain consensus for all the studies included. The screening
procedure was performed by two researchers; a PhD student
(NBM) and post-doctoral researcher (JM) who are experienced Narrative Synthesis
in systematic reviews and conservative management of chronic We performed the qualitative synthesis of the available infor-
pain on the Rayyan software (https://rayyan.qcri.org). mation by adopting and modifying the scale used by Bakker
et al. (Bakker et al., 2009). The number of studies evaluating an
intervention, the methodological quality of the studies and the
Assessment of Risk of Bias and Evidence Synthesis consistency of the available evidence was used to generate a
The risk of bias in the included studies was evaluated by two five-level of evidence using the modified scale as presented in
assessors (authors; NBM and JM) who were initially blinded Table 2 while the evidence of the included studies is contained
from each other’s evaluation. The Cochrane collaboration’s in Table 3.
tool for assessing ROB in randomized trials (Higgins et al.,
2011) was used for assessing the quality of the included studies, Quantitative Synthesis
and each study could be graded as having good, fair or poor
quality. The two assessors (NBM, JM) and a third author (MM) Meta-analysis was conducted using Review Manager (version
agreed a priori that, if a study has only one item rated unclear, 5.4). Data for meta-analysis was extracted from studies that the
while the remaining items were rated low ROB across the other data allow for meta-analyses using Microsoft Excel by the first
domains, a second step analysis was performed. Depending on author (NBM) and verified by another author (JM). Only stud-
the appraisal whether the unclear item rated was likely to have ies with control group (placebo or wait-list or treatment as
biased the outcome or not, such a study was considered as fair usual) were considered for the pairwise meta-analysis. For
or good quality, respectively. studies with two or more intervention groups, each intervention
On a general note, the overall methodological quality of the group was compared to the same control group by first calcu-
included RCTs was classified as either good, fair or poor after lating the standard error (SE) and subjecting it to approximate
taking into account all the domain scores as presented below: adjustment as recently described (Rücker et al., 2017). This
was necessary in order to conform with pairwise analysis, and
i. Nine out of the 35 studies were graded as having good also avoid unit of analysis error. Where appropriate, the stan-
methodological quality following assessment (Aguir- dard error of the outcomes were calculated using the statistical
rezabal et al., 2019; Alvarez-Melcon et al., 2018; John calculator available on the Review Manager. The pairwise
et al., 2007; Kanji et al., 2015; Lin & Wang, 2015; comparison for each outcome was based on the Generic inverse
Madsen et al., 2018; Seng et al., 2019; E. I. Söderberg variance (IV) method using random effects (RE) analysis in
et al., 2011; Varkey et al., 2011); view of the variation in the outcome measures in the studies.
ii. Thirteen studies were found to have fair quality Only subtotal analyses were performed in order to quantify the
(Bhombal et al., 2014; Bromberg et al., 2012; Calhoun effect of each hands-off therapy. The results were presented as
& Ford, 2007; D’Souza et al., 2008; Kleiboer et al., standardized mean differences (SMD), SE with their corre-
2014; Lee & Lee, 2019; Martin et al., 2014; Merelle spondent 95% confidence interval (CI). Statistical significance
et al., 2008; Rothrock et al., 2006; Sertel et al., 2017; was achieved at 0.05 alpha probability level.
Figure 1. Risk of bias/methodological quality assessment of the included studies. Key: þ (low risk), (high risk), ? (unclear risk).
Table 2. Modified Bakker Scale. had 84% agreement. The conflict on the remaining 16% differ-
ence (seven articles) was resolved after meeting.
Level of Criteria (Based on Good, Fair and Poor
Twenty two studies contributed to the meta-analysis. Of
Evidence Quality Studies)
these, five studies compared more than one treatment group
Strong evidence Consistent findings in two or more good quality with the same control group (Abdoli et al., 2012; D’Souza
studies, or one good quality and at least two fair et al., 2008; Sertel et al., 2017; Slavin-Spenny et al., 2013).
quality studies The remaining 13 studies not included in the meta-analyses
Moderate Consistent findings in one good quality study plus were only excluded because the available data was not appro-
evidence one fair quality study, or two fair quality studies
Limited evidence Only one fair or poor quality study is available
priate for meta-analysis (Abbott et al., 2007; Abdoli et al.,
Conflicting Inconsistent findings in the available studies 2012; Aguirrezabal et al., 2019; Calhoun & Ford, 2007; Dit-
evidence trich et al., 2008; Seng et al., 2019), or there was a lack of
Weak evidence Consistent findings in one fair quality study plus appropriate control group (Lee & Lee, 2019; Peres et al.,
one or more poor, or two or more poor, or just 2019; Rothrock et al., 2006; E. Söderberg et al., 2006; E. I.
one study is available but of good quality Söderberg et al., 2011), and/or the data was of poor quality
Note: Consistent finding is when at least 75% of the available studies reported (Lockett & Campbell, 1992). Of the four outcomes reported
the same conclusion. in the systematic review, only studies reporting on pain inten-
sity, disability and quality of life outcomes were included in the
meta-analysis. Sleep quality was only reported in the systema-
Results
tic review.
Study Selection
As shown in Figure 2, a total of 2,190 records were retrieved
from the online databases search. After the duplicates were Risk of Bias Within Studies
removed, 1,909 unique items remained. Of these, 1,847 articles Initially, the assessors had 83% agreement (203 out of 245
were excluded for not fulfilling the eligibility criteria (title and items). After an additional discussion, a consensus lead to
abstract screening). Thereafter, the full-text reports of the 99% agreement. The remaining differences were solved by the
remaining 62 articles were retrieved and evaluated based on consultation of the third assessor (MM). As for the overall
the inclusion and exclusion criteria. 35 articles met the inclu- assessment/grading of the included studies (good, fair or poor
sion criteria for the review and were included for the qualitative quality), there was only disagreement for three studies, and this
evidence synthesis. During the full-text screening, the assessors was resolved after discussing with the third assessor (MM).
Table 3. Evidence Table of Included Studies.
Outcome(s)
Reference Follow-Up
Country Sample Experimental Group (EG) Control Group (CG) Moments Results Evidence
Aerobic exercises
(Dittrich et al., 2008) Migraine: 30\ Aerobic exercise group (6w) Standard-care control: Pain: SES Pain # (P ¼ 0.024) Moderate evidence:
Austria EG: 15\(33.7 + 12.5 years) 45’ 2/w þ standard medical care Study information þ standard medical care QoL: PLCK QoL ! Pain intensity #
CG: 15\(32.1 + 12.1 years) Weak evidence:
(Lockett & Campbell, Migraine: 20\ Low impact aerobics (6w) Waitlist control: Pain: WHMPI Pain ! Disability # and sleep quality !
1992) EG: 11 (32.5 years) 45mins (dancing and calisthenics), 3/w Asked to wait for 12w due to lack of space Conflicting evidence: QoL
Canada CG: 09 (32.2 years)
(Narin et al., 2003) Migraine: 40\ (20–50 years) Aerobics group (8w) Control group: Pain: VAS Pain #
Turkey EG: 20 (35.20 + 10.23 years) 60’ 3/w þ medication Only medication Disability: PDI Disability#(P ⬍ 0.05)
CG: 20 (40.0 + 8.3 years) QoL:? QoL "
(Peres et al., 2019) Migraine/TTH/Chronic Aerobics group: (6 m) Relaxation group: 6 m Pain:? Pain # (P ⬍ 0.01)
Brazil headache: 74 20–30’ 3/w (6 months) 3/d, 3/w
EG: 5_, 19\ (38.0 + 13.1 Relaxation þ aerobics: aerobics and relaxation
years) together
CG (RLX): 4_, 21\ (41.1 +
16.4 years)
CG (RLXþPA): 5_, 20\(41.8
+ 19.7 years)
(Sertel et al., 2017) TTH: 60\ (39.26 + 9.23 years) Aerobics group (6w) Body awareness therapy group (6w) Pain: VAS Pain #
Turkey EG:20 (36.20 + 7.86 years) 60’ 3/w 60’ 1/w Disability: PDI Disability #
CG (BAT):20 (42.60 + 9.5 Control group: QoL: SF-36 QoL #
years)CG:20 (39.0 + 9.53 No treatment 3 m, 6 m, 12 m (P ⬍ 0.05)
years)
(E. Söderberg et al., TTH: 90 (18–59 years) Physical training group (10w) Acupuncture group (10–12w) Pain: [?] Pain ! (P ⬎ 0.05)
2006) EG:7_, 23\ (18–56 years)CG 45’ 2/w (5w)þ home training 3/w (5w) or 1 10–12 sessionsRelaxation group (10–12w) 3 m, 6 m
Sweden (ACU): 7_, 23\ (18–59 training at the clinic þ 1 or 2 home training/w 1/w
years) (10w)
CG (RLX): 9_, 27\ (22–59
years)
(E. I. Söderberg et al., TTH: 90 (18–59 years) Physical training group (10w) Acupuncture group (10–12w)10–12 sessions, 1/w Sleep-quality: Sleep quality !
2011) EG:7_, 23\ (18–56 years) 45’ 2/w (5w)þ home training 3/w (5w) or 1 Relaxation group (10–12w) MSEP
Sweden CG (ACU): 7_, 23\ (18–59 training at the clinic þ 1 or 1/w 6m
years) 2 home training/w (10w)
CG (RLX): 9_, 27\ (22–59
years)
(Varkey et al., 2011) Migraine: 91 (9_, 82\) Exercise (aerobics) group (12w) Relaxation group (12w) Pain: VAS Pain !
Sweden EG:30; 5_, 25\ (47.0 + 10.8 40’ 3/w 20–30’ 3/w QoL: MSQOL QoL !
years) Topiramate drug group: 6m
CG (RLX):30; 2_,28\ (41.50 + Individualized prescription
11.4 years)
CG (Drug):31; 2_, 29\ (44.4 +
9.2 years)
Active and stretching exercises
(Alvarez-Melcon TTH: 152 (68_, 84\) Head, neck & shoulder exercise group (4w) Control group (4w) Pain: VAS Pain # (P ¼ 0.015 & P
et al., 2018) EG:76; 26_, 50\ (20.23 + 2.50 Exercises þ ergonomics and hygiene þ relaxation þ Ergonomics and hygiene þ relaxation þ autogenic 3m ¼ 0.006 at follow Weak evidence: Pain intensity #
Spain years) autogenic training 7x/w training 7x/w up)
CG:76; 42_, 34\ (20.62 + 2.21
years)
(Lee & Lee, 2019) TTH: 62 (26_, 36\; 19–29 Stretching exercise group (4w) Biofeedback group (4w) Disability: HDI Disability !
Korea years) 25’ 3/w (Ylinen et al.) 13’ 3/w 2w
EG: 21; 6_, 15\ (22.10 + Manual therapy group (4w)
2.31years) 20’ 3/w
CG (Biofeedback): 21; 7_, 14\
(22.91 + 2.84 years)
5
(continued)
6
Table 3. (continued)
Outcome(s)
Reference Follow-Up
CG (Manual therapy): 20; 6_,

14\ (21.40 + 2.47 years)
(Lin & Wang, 2015) Chronic headache: 60\ Stretching exercises group (30’) Control group Pain: NRS Pain # (P ¼ 0.01)
Taiwan EG: 30 (31.7 + 6.1 years) 25’ neck stretching Management as usual
CG: 30 (31.2 + 5.2 years)
Progressive resistance training
(Madsen et al., 2018) TTH: 60 (19_, 41\) Strength training group (10w) Control group Pain: NRS Pain ! (P ¼ 0.375) Weak evidence:
Denmark EG:30; 8_, 22\ (32(28–37) 3/w (70%–80% of maximal intensity) Ergonomics and posture correction 19–22w Pain intensity !
years)
CG:30; 11_, 19\ (35(31–39)
years)
Behavioral/Cognitive therapies
(Bhombal et al., Migraine: 90 (18_, 72\) BT group (2w) Control group;: Pain:? Pain # (P ¼ 0.001)
2014) EG:45; 6_, 39\ (36.7 + 1.5 Daily þ standard pharmacological treatment Standard pharmacological treatment QoL:? QoL " (P ¼ 0.001) Conflicting evidence: Pain intensity,
Pakistan years) 4w QoL, disability
CG:45; 12_, 33\ (34.6 + 1.8 Limited evidence: Sleep quality "
years)
(Bromberg et al., Migraine: 185 (20_, 165\) BT group (4w) Control: Disability: Disability !
2012) EG:93; 10_, 83\ (43.32 + Web-based BT, 20’ 2/w þ 20’sessions 5x follow up No treatment MIDAS
USA 11.49 years) (1 m) m, 6 m
CG:92; 10_, 82\ (41.91 +
11.53 years)
(Calhoun & Ford, Migraine: 43\ BT group (6w) Control; Sleep quality: Sleep quality " (P ¼
2007) EG: 23 (33.5 years) Behavioral sleep modification (BSM) instructions þ Sham instructions þ usual car SCI 0.01)
USA CG: 20 (35.0 years) usual care
(Devineni & Migraine, TTH or Mixed: 139 BT group (4w) Control group Disability: HDI Disability # (P ⬍ 0.05)
Blanchard, 2005) (29_, 110\) internet-delivered BT, 1/w symptom monitoring waitlist control
USA EG: 39; 05_, 34\ (43.6 + 12
years)
CG: 47; 10_, 37\ (41.0 + 11.8
years)
Dropout: 53; 14_, 39\ (39.2 +
14.7 years)
(Kleiboer et al., Migraine: 368 (54_, 314\) BT group (3 m) Control group;: Pain:? Pain ! (P ⬎ 0.05)
2014) EG: 26_, 169\ (43 + 12 years) Online BT for 8 sessions (60’ per session) þ home Wait list QoL: MSQOL QoL "
Netherlands CG: 28_, 145\ (44.3 + 11 works Disability: Disability #
years) MIDAS
(Martin et al., 2014) Migraine: 127 (43_, 84\) CBT þ Avoidance group (8w) Avoidance group (8w) Pain ! [NRS] Pain !
Australia EG: 15_, 19\ (48.94 + 13.65) Avoidance of triggers þ CBT 1/w 1/w Avoidance of triggers 4 m, 12 m
CG(Avoidance): 11_, 18\ Coping group (8w)
(48.28 + 12.57) learning to cope with triggers 1/w
CG (Coping): 12_, 20\ (44.53 Control group:
+ 13.85) WLC
CG: 05_, 27\ (46.91 + 15.15)
(Merelle et al., 2008) Migraine: 127 (13_, 87\) BT group (10w) Control group: Pain:? Pain !
Netherlands EG: 60; 09_, 51\ (25–59) 7, 120’ sessions of home based BT Wait list (care as usual) Disability: Disability !
CG: 67; 07_, 60\ (18–65) MIDAS QoL !
QoL: MSQOL
(Seng et al., 2019) Migraine: 60 (5_, 55\) BT group (8–10w) Control: Pain: HD
USA EG: 02_, 29\ (36.2 + 10.6) 8 individual 75’ sessions of mindfulness-based Waitlist/treatment as usual Disability: HDI Pain !
CG: 03_, 26\ (44.2 + 11.5) cognitive therapy Disability #
Pain: NRS
(continued)
Outcome(s)
Reference Follow-Up
(Sorbi et al., 2015) Migraine: 368 (54_, 314\) BT group (3.6months) Control: Pain # (P ⬍ 0.032)
Netherlands EG: 26_, 169\ (43.0 + 8 lessons of online BT for 60’ þ 60’–120’of WLC/no treatment Disability ! (P ⬎
12.0)CG: 28_, 145\ (44.3 + homework 0.05)
11.0) QoL ! (P ¼ 0.051)
(Tavallaei et al., 2018) Migraine, TTH: 30\ BT group (8w) Control: Pain: MPQ Pain # (P ⬍ 0.035)
Iran EG: 15 (32.47 + 9.11) Mindfulness based stress reduction (MBSR) weekly Medical treatment as usual (MTAU) Disability: Disability # (P ⬍
CG: 15 (34.87 + 9.12) þ MTAU MIDAS 0.0001)
Relaxation training
(D’Souza et al., 2008) Migraine, TTH: 141 (19_, 122\) Relaxation group (2w) Written emotional disclosure (2w) Disability: Disability # (P ⬍ 0.05)
USA TTH: 51; 9_,42\ (20.3 + 2.30 4, 20’ sessions of self-administered relaxation 4, 20’ sessions MIDAS Moderate evidence: Pain intensity #,
years) Control; 1 m, 3 m disability #
Migraine: 90; 10_,80\ (21.4 + Time management Weak evidence:
5.47 years). Sleep quality ", QoL !
(McGrady et al., Migraine: 23 (3_, 20\) Relaxation group (8–12w) 12 sessions þ 2 daily home Control (self relax) group Pain ! [HPIS] Pain # (P ⬍ 0.01)
1994) EG: 12; 42 (29–59 years) training) Self relax for 10–15mins twice weekly (8–12 weeks) 4–6w
USA CG: 11; 42 (29–53 years)
(Peres et al., 2019) Migraine/TTH/Chronic Relaxation group: 6 m Relaxation þ aerobics: aerobics and relaxation Pain:? Pain !
Brazil headache: 74 3/d, 3/w together
EG (RLX): 4_, 21\ (41.1 + Aerobics group: (6 m)
16.4 years) 20–30’ 3/w (6 months)
CG (RLXþPA): 5_, 20\(41.8
+ 19.7 years)
CG (PA): 5_, 19\ (38.0 + 13.1
years)
(Slavin-Spenny et al., Chronic headache: 147 Relaxation group (4w) Anger awareness therapy group (4w) Disability: Disability # (P ¼ 0.03)
2013) (18_,129\) Daily routines training 3 sessions MIDAS
USA EG:** Control (waitlist) group:
CG:** No treatment
(E. Söderberg et al., TTH: 90 (18–59 years) Relaxation group (10–12w) Physical training group (10w) Pain:? Pain ! (P ⬎ 0.05)
2006) EG:7_, 23\ (18–56 years) 1/w 45’ 2/w (5w)þ home training 3/w (5w) or 1 3 m, 6 m
Sweden CG (ACU): 7_, 23\ (18–59 training at the clinic þ 1 or 2 home training/w
years) (10w)
CG (RLX): 9_, 27\ (22–59 Acupuncture group (10–12w)
years)
(E. I. Söderberg et al., TTH: 90 (18–59 years) Relaxation group (10–12w) Physical training group (10w) Sleep quality: Sleep quality "
2011) EG:7_, 23\ (18–56 years) 1/w 45’ 2/w (5w)þ home training 3/w (5w) or 1 MSEP (P ⬍ 0.05)
Sweden CG (ACU): 7_, 23\ (18–59 training at the clinic þ 1 or 2 home training/w 3 m, 6 m
years) (10w)
CG (RLX): 9_, 27\ (22–59 Acupuncture group (10–12w)
years)
(Varkey et al., 2011) Migraine: 91 (9_, 82\) Relaxation group (12w) Exercise (aerobics) group (12w) Pain: VAS Pain !
Sweden EG (RLX):30; 2_,28\ (41.50 + 20–30’ 3/w 40’ 3/w QoL: MSQOL QoL !
11.4 years) Topiramate drug group: 3 m, 6 m
CG (Aerobics):30; 5_, 25\ Individualized prescription
(47.0 + 10.8 years)
CG (Drug):31; 2_, 29\ (44.4 +
9.2 years)
Avoidance, coping and stress management
(Bakhshani et al., Migraine, TTH: 40 (13_, 27\) Mindfulness based stress reduction group (8w) Control group;: Pain: NRS Pain # (P ¼ 0.001)
2015) EG: 20; 6_,14\ (30.6 + 9.08 MBSR therapy of 90’–120’/w þ pharmacotherapy pharmacotherapy QoL: [SF-36] QoL " (P ⬍ 0.05) Weak evidence: Pain intensity #, QoL ",
Iran years) Anti-depressant group: disability # for stress management
CG: 20; 7_,13\ (31.5 + 9.57 Medication only Conflicting evidence: Pain intensity for
years) coping techniques
7
(continued)
8
Outcome(s)
Reference Follow-Up
(Holroyd et al., 2001) TTH: 203 (48_, 155\) Stress management therapy (STM) group (2 m) Anti-depressant þSTM (2 m) Disability: HDI Disability # (P ⬍ 0.01) Limited evidence: Pain intensity # for
USA EG: 49; 10_, 39\ (37.4 + 1.7 Counselor administered 3, 60’ sessions Combination of the two 1 m, 6 m avoidance of triggers
years) Control group:
CG (Drug þ STM): 53; 10_,43\ Placebo
(37.1 + 1.7 years)
CG (Drug): 53; 18_, 35\ (35.6
+ 1.5 years)
CG: 48
(Martin et al., 2014) Migraine: 127 (43_, 84\) Avoidance group (8w) CBT þ Avoidance group (8w) Pain: NRS Pain # (P ¼ 0.001) for
Australia EG(Avoidance): 11_, 18\ 1/w Avoidance of triggers Avoidance of triggers þ CBT 1/w coping group
(48.28 + 12.57) Coping group (8w) Control group:
EG (Coping): 12_, 20\ (44.53 learning to cope with triggers 1/w WLC
+ 13.85)
CG (CBT þ Avoidance): 15_,
19\ (48.94 + 13.65)
CG: 05_, 27\ (46.91 + 15.15)
(Rashid-Tavalai et al., Migraine: 35 (7_, 28\) Coping skills group (7w) Control group: Pain: HI Pain ! (P ¼ 0.26)
2015) EG: 03_, 15\ 7, 120’/w sessions of coping skills þ Pharmacotherapy QoL: QoL ! (P ¼ 0.49)
Iran CG: 04_, 13\ pharmacotherapy WHOQOL
Education
(Aguirrezabal et al., Migraine: 116 (21_, 95\) Pain education group (2 m) Control group Pain:? Pain # (P ⬍ 0.005) Moderate evidence:
2019) EG: 57; 13_, 44\ Five, 105’ sessions of pain neuroscience education þ Usual care (periodical primary care appointments) Disability: Disability # (P ⬍ Disability #
Spain CG: 59; 08_, 51\ usual care MIDAS 0.001)
(Rothrock et al., Migraine: 100 (8_, 92\) Pain education group (1 m) Control group: Disability: Disability # (P ⬍ 0.05) Weak evidence:
2006) EG: 50; 4_, 46\ (43.4 years) 3 classes of 90’ þ usual care Usual care MIDAS Pain intensity #
USA CG: 50; 4_, 46\ (41.6 years) 3 m, 6m
Psychotherapy (Acceptance and commitment therapy)
(Khazraee et al., Migraine, Chronic headache: 40 Psychotherapy (acceptance and commitment therapy) (2 Control group: Pain: HD Pain # (P ⬍ 0.05) Limited evidence: Pain intensity #,
2018) (3_, 30\) m) MTAU Disability: HDI Disability # (P ⬍ 0.05) disability #
Iran EG: 02_, 14\ (33.76 years) Eight 90’/w sessions þ MTAU (2 months)
CG: 01_, 16\ (33.24 years)
Biofeedback exercises
(Lee & Lee, 2019) TTH: 62 (26_, 36\; 19–29 Biofeedback group (4w) Manual therapy group (4w) Disability: HDI Disability # (P ⬍ 0.01) Weak evidence: Disability #
Korea years) 13’ 3/w 20’ 3/w QoL:? QoL " (P ⬍ 0.05)
EG (Biofeedback): 21; 7_, 14\ Stretching exercise group (4w) 2w
(22.91 + 2.84 years) 25’ 3/w (Ylinen et al.)
CG (Manual therapy): 20; 6_,
14\ (21.40 + 2.47 years)
CG (Stretching): 21; 6_, 15\
(22.10 + 2.31years)
Guided imagery
(Abdoli et al., 2012) TTH: 60 (18_,42\) Guided imagery with tape (5w) Control group (5w) Pain: VAS Pain # (P ⬍ 0.0001) Limited evidence: Pain intensity #
Iran EG (Imagery):20; 7_, 13\ Imagery with tape, 3 times per week þ individualized Individualized headache therapy
(33.1(20–57)years) headache therapy
EG (Happy memory): 20; 5_, Guided imagery with perceived happy memory (5w)
15\ (32.7(19–53) years) Happiest personal memory, 3 times per week þ
CG: 20; 6_, 14\ (32.4(20–59) individualized headache therapy
years)
Tai-chi
(Abbott et al., 2007) TTH: 30 (8_, 22\) Tai-Chi group (15w) Control (waitlist) group: QoL: SF-36 QoL " (P ¼ 0.016) Limited evidence: QoL "
USA EG: 03_, 10\ (47 years) Yang style short form of Tai Chi delivered bi-weekly WLC
CG: 04_, 12\ (42 years)
Sauna
(continued)
Outcome(s)
Reference Follow-Up
(Kanji et al., 2015) TTH: 37 (8_, 29\) Sauna group (8w) Control group: Pain: NRS Pain # (P ¼ 0.002) Weak evidence: Pain intensity #,
New Zealand EG: 17; 05_, 12\(44.3 + 10.5 Self-directed soft tissue massage þ 20’ sauna 3/w Self-directed soft tissue massage Sleep quality:? Sleep quality ! (P ¼ disability #
years) 0.77)
CG: 20; 03_, 17\(40.7 + 16.8
years)
Yoga
(John et al., 2007) Migraine: 65 (16_, 49\) Yoga group (12w) Control group: Pain: NRS Pain # (P ⬍ 0.001) Weak evidence: Pain intensity #
India EG: 10_, 22\ (34.38 + 8.74 60’ session, 5x/w Self-care
years)
CG: 06_, 27\ (34.21 + 9.66
years)
Legend abbreviations and signs: CBT ¼ Cognitive behavioral therapy, BT ¼ Behavioral therapy, HD ¼ headache diary, HDI ¼ headache disability index, HI ¼ headache index, HPIS ¼ headache pain intensity score,
MSEP ¼ Minor Symptom Evaluation Profile questionnaire, PDI ¼ pain disability index, MBSR ¼ mindfulness based stress reduction, MIDAS ¼ migraine disability assessment score, MPQ ¼ McGill pain questionnaire,
MSQOL ¼ migraine specific quality of life questionnaire, MTAU ¼ medical treatment as usual, NRS ¼ numeric rating scale, PLCK ¼ profil der lebensqualität chronisch kranker, QoL ¼ Quality of life, SCI ¼ sleep
characteristics inventory, SES ¼ Schmerzempfindungsskala, TTH¼ Tension type headache, SF-36 ¼ short form 36, VAS ¼ visual analogue scale, WHMPI ¼ West Haven Yale multidimensional pain inventory,
WHOQOL ¼ world health organization quality of life, WLC ¼ wait list control, " ¼ improvement through increase, # ¼ improvement through decrease, ! ¼ no difference in improvement,? ¼ name of outcome tool
not specified by researcher(s), **¼ no group based data.
Note: Only studies that presented p-values were reflected in the table.
9
Idenficaon Records idenfied through PubMed Records idenfied through Web of Science
database searching database searching
(n = 1569+25*=1594) (n = 470+126*=596)
Records aer duplicates removed

(n = 1786+123*=1909)
Screening
Records screened Records excluded

(n = 1786+123*=1909) (n = 1735+112*=1847)
Eligibility
Full-text arcles excluded based on

the inclusion/exclusion criteria
(n = 27)
Full-text arcles assessed for eligibility
(n = 51+11*=62) Excluded due to; Age =2,
Intervenon=7, Populaon= 5,
Study design= 8, outcome=4, no
full text=1
Included
Studies included in qualitave synthesis

(n = 35) Studies excluded in meta-analysis
(n = 13)
Data not appropriate for MA =7

Lack of placebo/waitlist/TAU
control= 5, Poor quality of
data/graphs=1
Studies included in meta-analysis
(n = 22)
Figure 2. PRISMA flow chart of the review process. Note: * ¼ Additional articles obtained due to update of the database search, MA ¼ Meta-
analysis, TAU ¼ Treatment as usual.
Study Characteristics et al., 2018; Peres et al., 2019; Sertel et al., 2017; E. Söderberg
et al., 2006; E. I. Söderberg et al., 2011; Tavallaei et al., 2018),
A total of 3,403 (2,797 females) patients with different types of
while four studies investigated patients with primary chronic
headaches participated across the included studies. Majority of
headaches (Khazraee et al., 2018; Lin & Wang, 2015; Peres
the participants were females (82%) mainly having migraine,
et al., 2019; Slavin-Spenny et al., 2013). The sample size of
TTH and chronic headache. Twenty-three out of the 35 studies included studies varied from 20 to 368.
reported on migraine (Aguirrezabal et al., 2019; Bakhshani The hands-off interventions reported are; aerobic exercises
et al., 2015; Bhombal et al., 2014; Bromberg et al., 2012; (Dittrich et al., 2008; Lockett & Campbell, 1992; Narin et al.,
Calhoun & Ford, 2007; D’Souza et al., 2008; Devineni & 2003; Peres et al., 2019; Sertel et al., 2017; E. Söderberg et al.,
Blanchard, 2005; Dittrich et al., 2008; John et al., 2007; Khaz- 2006; E. I. Söderberg et al., 2011; Varkey et al., 2011), avoid-
raee et al., 2018; Kleiboer et al., 2014; Lockett & Campbell, ance training (Martin et al., 2014), behavioral/cognitive ther-
1992; Martin et al., 2014; McGrady et al., 1994; Merelle et al., apy (Bhombal et al., 2014; Bromberg et al., 2012; Calhoun &
2008; Narin et al., 2003; Peres et al., 2019; Rashid-Tavalai Ford, 2007; Devineni & Blanchard, 2005; Kleiboer et al., 2014;
et al., 2015; Rothrock et al., 2006; Seng et al., 2019; Sorbi Martin et al., 2014; Merelle et al., 2008; Seng et al., 2019; Sorbi
et al., 2015; Tavallaei et al., 2018; Varkey et al., 2011), 15 et al., 2015; Tavallaei et al., 2018), biofeedback exercises (Lee
reported on tension type headache (Abbott et al., 2007; Abdoli & Lee, 2019), guided imagery (Abdoli et al., 2012), pain edu-
et al., 2012; Alvarez-Melcon et al., 2018; Bakhshani et al., cation (Aguirrezabal et al., 2019; Rothrock et al., 2006), learn-
2015; D’Souza et al., 2008; Devineni & Blanchard, 2005; Hol- ing to cope with triggers (Martin et al., 2014; Rashid-Tavalai
royd et al., 2001; Kanji et al., 2015; Lee & Lee, 2019; Madsen et al., 2015), psychotherapy (acceptance and commitment
Mukhtar et al. 11
therapy) (Khazraee et al., 2018), relaxation training (D’Souza Narrative Synthesis of the Review Results
et al., 2008; McGrady et al., 1994; Peres et al., 2019; Slavin-
Spenny et al., 2013; E. Söderberg et al., 2006; E. I. Söderberg Exercise Training
et al., 2011; Varkey et al., 2011), stress management therapy Twelve studies (Alvarez-Melcon et al., 2018; Dittrich et al.,
(Holroyd et al., 2001), Tai-Chi (Abbott et al., 2007), sauna 2008; Lee & Lee, 2019; Lin & Wang, 2015; Lockett & Camp-
(Kanji et al., 2015) and yoga (John et al., 2007). Other bell, 1992; Madsen et al., 2018; Narin et al., 2003; Peres et al.,
hands-off interventions tested in the studies are self- 2019; Sertel et al., 2017; E. Söderberg et al., 2006; E. I. Söder-
administered; strength training (Madsen et al., 2018) and berg et al., 2011; Varkey et al., 2011) reported treatment effects
stretching exercises (Lee & Lee, 2019; Lin & Wang, 2015). of different types of exercise interventions in headache man-
For the outcomes: pain intensity in the studies was majorly agement. Aerobic exercises/physical training for headache
assessed by Visual Analogue Scale (VAS) (Abdoli et al., was reported in eight studies (Dittrich et al., 2008; Lockett
2012; Alvarez-Melcon et al., 2018; Narin et al., 2003; Sertel & Campbell, 1992; Narin et al., 2003; Peres et al., 2019;
et al., 2017; Varkey et al., 2011) and Numeric Rating Scale Sertel et al., 2017; E. Söderberg et al., 2006; E. I. Söderberg
(NRS) (Bakhshani et al., 2015; John et al., 2007; Kanji et al., et al., 2011; Varkey et al., 2011), of which seven (Dittrich
2015; Lin & Wang, 2015; Madsen et al., 2018; Martin et al., et al., 2008; Lockett & Campbell, 1992; Narin et al., 2003;
2014; Sorbi et al., 2015); quality of life (QoL) was assessed by Sertel et al., 2017; E. Söderberg et al., 2006; Varkey et al.,
migraine specific quality of life (MSQOL) (Kleiboer et al., 2011) assessed pain intensity as the study outcome. The
2014; Merelle et al., 2008; Sorbi et al., 2015; Varkey et al., results indicated that pain intensity was only significantly
2011), world health organization quality of life (WHOQOL) reduced in patients with headaches compared to control sub-
(Rashid-Tavalai et al., 2015) and SF-36 questionnaires (Abbott jects in four studies (Dittrich et al., 2008; Narin et al., 2003;
et al., 2007; Bakhshani et al., 2015; Sertel et al., 2017); dis- Peres et al., 2019; Sertel et al., 2017). Three other studies
ability was assessed using migraine disability assessment scale (Lockett & Campbell, 1992; E. Söderberg et al., 2006; Varkey
(MIDAS) (Aguirrezabal et al., 2019; Bromberg et al., 2012; et al., 2011), reported no significant reduction in pain inten-
D’Souza et al., 2008; Merelle et al., 2008; Rothrock et al., sity compared to control.
2006; Seng et al., 2019; Slavin-Spenny et al., 2013; Sorbi Quality of life was reported across three studies (Narin et al.,
et al., 2015; Tavallaei et al., 2018), pain disability index (PDI) 2003; Sertel et al., 2017; Varkey et al., 2011), of which two
(Narin et al., 2003; Sertel et al., 2017) and headache disability recorded significant improvements (Narin et al., 2003; Sertel
index/inventory (HDI) (Devineni & Blanchard, 2005; Holroyd et al., 2017). Furthermore, two studies reported significant
et al., 2001; Khazraee et al., 2018; Lee & Lee, 2019; Seng et al., reduction in disability level following exercise training (Narin
2019); and sleep quality was assessed by Minor Symptom et al., 2003; Sertel et al., 2017). One study investigated sleep
Evaluation Profile questionnaire (MSEP) (E. I. Söderberg quality and no significant difference existed when compared
et al., 2011) and sleep characteristics inventory (Calhoun & with the control (E. I. Söderberg et al., 2011). One study
Ford, 2007). In this review, 26 (Abdoli et al., 2012; Aguirre- (Alvarez-Melcon et al., 2018) reported that active exercises
zabal et al., 2019; Alvarez-Melcon et al., 2018; Bakhshani of head, neck and shoulder decreases pain intensity, while two
et al., 2015; Bhombal et al., 2014; Dittrich et al., 2008; John studies reported different results for the efficacy of stretching
et al., 2007; Kanji et al., 2015; Khazraee et al., 2018; Kleiboer exercises of the neck and chest regions in decreasing pain
et al., 2014; Lin & Wang, 2015; Lockett & Campbell, 1992; intensity among patients with headache (Lee & Lee, 2019;
Madsen et al., 2018; Martin et al., 2014; McGrady et al., 1994; Lin & Wang, 2015). Lastly, Madsen et al. investigated the
Merelle et al., 2008; Narin et al., 2003; Peres et al., 2019; effects of progressive strength training for headache patients
Rashid-Tavalai et al., 2015; Seng et al., 2019; Sertel et al., and they found that there was no significant difference in pain
2017; Slavin-Spenny et al., 2013; E. Söderberg et al., 2006; intensity compared to the control after intervention (Madsen
Sorbi et al., 2015; Tavallaei et al., 2018; Varkey et al., 2011), et al., 2018).
10 (Bakhshani et al., 2015; Bhombal et al., 2014; Dittrich et al., It was concluded that aerobic exercises are effective
2008; Kleiboer et al., 2014; Merelle et al., 2008; Narin et al., in reducing pain intensity among patients with headache
2003; Rashid-Tavalai et al., 2015; Sertel et al., 2017; Sorbi (moderate evidence). The evidence to support reduction in
et al., 2015; Varkey et al., 2011), 18 (Aguirrezabal et al., disability and improvement in sleep quality among patients
2019; Bromberg et al., 2012; D’Souza et al., 2008; Devineni with headache following aerobic exercises is weak. Meanwhile,
& Blanchard, 2005; Holroyd et al., 2001; Kanji et al., 2015; conflicting evidence was found on the effects of aerobic exer-
Khazraee et al., 2018; Kleiboer et al., 2014; Lee & Lee, 2019; cises in enhancing QoL.
Merelle et al., 2008; Narin et al., 2003; Peres et al., 2019; Furthermore, there is weak evidence to support the use of
Rothrock et al., 2006; Seng et al., 2019; Sertel et al., 2017; active and stretching exercises of the head, neck and shoulder
Slavin-Spenny et al., 2013; Sorbi et al., 2015; Tavallaei in reducing pain intensity among patient with headache.
et al., 2018) and three (Calhoun & Ford, 2007; Kanji et al., Lastly, weak evidence suggests that progressive resistance
2015; E. I. Söderberg et al., 2011) RCTs reported on pain training is not effective in reducing pain intensity for these
intensity, QoL, disability and sleep quality, respectively. patients.
Behavioral and/or Cognitive Therapies Söderberg et al., 2011; Varkey et al., 2011). Lastly, one study
assessed the impact of relaxation training on sleep quality and
The effects of behavioral and/or cognitive therapy in the man-
the results indicated that the intervention had no significant
agement of headache was investigated across 10 studies
effect on sleep quality (E. I. Söderberg et al., 2011).
(Bhombal et al., 2014; Bromberg et al., 2012; Calhoun & Ford,
There is moderate level evidence to support the effect of
2007; Devineni & Blanchard, 2005; Kleiboer et al., 2014; Mar-
relaxation training in reducing disability and pain intensity.
tin et al., 2014; Merelle et al., 2008; Seng et al., 2019; Sorbi
The evidence to support the use of relaxation training on sleep
et al., 2015; Tavallaei et al., 2018). Pain intensity was assessed
quality is weak. The use of relaxation training does not
in seven studies (Bhombal et al., 2014; Kleiboer et al., 2014;
improve QoL of patients with headache (strong evidence).
Martin et al., 2014; Merelle et al., 2008; Seng et al., 2019; Sorbi
et al., 2015; Tavallaei et al., 2018), however, a significant
reduction in pain intensity among patients with headaches com- Avoidance, Coping and Stress Management
pared to control group was only found in three studies (Bhom- Techniques
bal et al., 2014; Sorbi et al., 2015; Tavallaei et al., 2018), the
Avoidance, coping and/or stress management techniques were
remaining studies reported comparable results (Kleiboer et al.,
reported in four studies (Bakhshani et al., 2015; Holroyd et al.,
2014; Martin et al., 2014; Merelle et al., 2008; Seng et al.,
2001; Martin et al., 2014; Rashid-Tavalai et al., 2015). Bakh-
2019). Of the seven studies that assessed the effects of beha-
shani et al. (Bakhshani et al., 2015) and Holroyd et al. (Holroyd
vioral and/or cognitive therapy on disability level (Bromberg
et al., 2001) found significant improvement in pain intensity,
et al., 2012; Devineni & Blanchard, 2005; Kleiboer et al., 2014;
disability and QoL of patients with headache following stress
Merelle et al., 2008; Seng et al., 2019; Sorbi et al., 2015;
management. Secondly, while Martin et al. (Martin et al., 2014)
Tavallaei et al., 2018), only four studies recorded significant
found coping techniques to significantly reduce pain intensity,
reductions in disability scores (Devineni & Blanchard, 2005;
Rashid-Tavalai et al. (Rashid-Tavalai et al., 2015) did not find
Kleiboer et al., 2014; Seng et al., 2019; Tavallaei et al., 2018).
any significant impact. Finally, Martin et al. (Martin et al.,
Quality of life was assessed by four studies (Bhombal et al.,
2014) reported the effect of avoidance of triggers and it was
2014; Kleiboer et al., 2014; Merelle et al., 2008; Sorbi et al.,
not effective in reducing pain intensity.
2015), and significant improvement in QoL scores was
There is weak evidence to support the use of stress man-
reported in only two of these studies (Bhombal et al., 2014;
agement therapy for improving pain intensity, disability and
Kleiboer et al., 2014). Lastly, one study investigated and found
QoL of patients with headache. There is conflicting evidence to
sleep quality to be significantly improved following behavioral
support the effect of coping techniques on pain intensity, the
therapy (Calhoun & Ford, 2007).
evidence to support the use of avoidance of triggers in man-
It was concluded that there is conflicting evidence to support
aging pain intensity among patients with headache is limited.
the effectiveness of behavioral and/or cognitive therapies in
improving pain intensity, QoL and disability levels, while the
evidence to support their efficacy on sleep quality of patients Education
with headache is limited.
Two studies by Rothrock et al. (Rothrock et al., 2006) and
Aguirrezabal et al. (Aguirrezabal et al., 2019) reported on the
effect of pain education in the management of headache. In
Relaxation Training comparison with control group, education was found to signif-
The use of relaxation training for managing patients with head- icantly reduce disability levels in both studies, while pain inten-
ache was reported across seven studies (D’Souza et al., 2008; sity was significantly reduced in one study (Aguirrezabal et al.,
McGrady et al., 1994; Peres et al., 2019; Slavin-Spenny et al., 2019) among patients with headache.
2013; E. Söderberg et al., 2006; E. I. Söderberg et al., 2011; There is moderate and weak level evidence to support using
Varkey et al., 2011). Out of four studies that reported the pain education for reducing disability and pain intensity
effects of relaxation training on pain intensity (McGrady among headache patients, respectively.
et al., 1994; Peres et al., 2019; E. Söderberg et al., 2006; Var-
key et al., 2011), two studies reported significant pain reduction
among patients with headaches compared to control (McGrady
Other Interventions
et al., 1994; Peres et al., 2019). D’Souza et al. (D’Souza et al., The effects of psychotherapy in form of acceptance and com-
2008) and Slavin-Spenny et al. (Slavin-Spenny et al., 2013) mitment therapy (ACT) in patients with headache was reported
investigated and found that relaxation training significantly by Khazraee et al. (Khazraee et al., 2018), and their results
reduced the disability scores of patients with headaches com- indicated significant reduction in pain intensity and disability.
pared to the control groups. In contrast, two studies investi- One study by Lee and Lee reported that biofeedback exercises
gated the impact of relaxation training on the QoL, but did not led to significant reduction in headache related disability (Lee
find any significant difference between the experimental and & Lee, 2019). Abdoli et al. (Abdoli et al., 2012) assessed the
other groups comprising of stand-alone interventions (acu- effects of guided imagery in the management of patients with
puncture, exercise training and topiramate drug) (E. I. headache, and they found a significant reduction in headache
Mukhtar et al. 13
pain intensity. Abbott et al. (Abbott et al., 2007) reported on the awareness therapy. Interventions such as sauna, progressive
effects of Tai-Chi in the treatment of headache patients, and resisted exercise, avoidance therapy, acceptance and commit-
reported a significant improvement in QoL among the patients ment, coping, and written and emotional disclosure did not
compared to the control group. Kanji et al. reported on the have any significant effect. On the overall, beside stress man-
effects of Sauna in managing pain intensity, disability and agement, none of the other hands-off therapies was effective in
sleep quality among patients with headache patients (Kanji improving the quality of life of patients with headache.
et al., 2015). Their results indicated significant reduction in
pain intensity and disability, but not sleep quality among
patients with headache compared to the control group. John Discussion
et al. (John et al., 2007) assessed the effect of Yoga in the The present SR and meta-analysis evaluated the existing evi-
management of headache, and they reported a significant dence for the effectiveness of hands-off therapy in the manage-
reduction in pain intensity among the experimental group in ment of patients suffering from primary headache. To our
comparison to the control group. knowledge, this is the first study to categorize hands-off thera-
For improvement in pain intensity, the evidence to support pies as an intervention group and review its effectiveness.
the use of sauna bathing and yoga in patients with headache is Although some of the therapies may be administered as adju-
weak while ACT and guided imagery are supported by limited vant therapies, a lot of other therapies are prescribed as stan-
evidence. Additionally, there is weak evidence supporting the dalone treatment thereby necessitating evidence for their
effectiveness of biofeedback exercises, and sauna bathing in effectiveness. The results of this SR, as supported by moderate
improving disability in patients with headache whereas ACT evidence, found aerobic exercises, relaxation training and pain
is supported by weak evidence. Lastly, there is limited evidence education as the effective hands-off therapies for primary
supporting the effectiveness of Tai-Chi in improving QoL of headache management. In a somewhat similar fashion, the
patients with headache. meta-analysis result found hands-off therapies such as aerobic
exercise and relaxation training to be effective in decreasing
Quantitative Synthesis of the Review Results pain intensity and disability, but rarely for improving quality of
life for primary headache patients.
The results of the pairwise meta-analyses indicated the effect of
14, eight and five hands-off therapies on pain intensity, dis-
ability and quality of life respectively (Figure 3A, B, and C).
Exercise Training
The sub-group analyses showed that the effect of hands-off Although several hands-off therapy methods were reported in
therapies significantly differed for all the three outcomes ana- the included studies of this SR, there are varying effects of the
lyzed as follows; pain intensity (X2 ¼ 161.80; I2 ¼ 92%; p ¼ interventions used. Self-administered exercises were the most
0.00001), disability (X2 ¼ 20.01; I2 ¼ 64%; p ¼ 0.006) and common hands-off therapy used in managing headache patients.
quality of life (X2 ¼ 18.55; I2 ¼ 78.4%; p ¼ 0.0010). Beha- Aerobic exercises were the most frequent type of exercises used
vioral/Cognitive therapy was the mostly reported hands-off in reducing pain and disability among these patients in the SR
therapy. However, the results indicated that it had only a small (moderate evidence). This is not surprising because aerobic exer-
effect on pain intensity (Effect size ¼ 0.17; CI ¼ 0.30 to cises were considered as a new approach for migraine prevention
0.04; I2¼; 0%; p ¼ 0.010), moderate effect on disability and treatment (Nicholson et al., 2011). Moreover, exercises have
(Effect size ¼ 0.5; CI ¼ 0.88 to 0.13; I2¼; 88%; p ¼ been reported to induce analgesia by activation of central inhi-
0.009) and no significant effect on quality of life (Effect size ¼ bitory pathways (Lima et al., 2017). On the other hand, weak
0.09; CI; 0.24 to 0.05; I2¼; 9%; p ¼ 0.22). Aerobic exercise evidence (SR) was mostly found to support improvement in
training also showed a large effect on pain intensity (Effect size sleep quality and a conflicting evidence on QoL. The meta-
¼ 2.23; CI ¼ 2.81 to 1.66; I2¼; 0%; p ⬍ 0.00001), but not analysis results only included a few of the studies reporting on
for disability level (Effect size ¼ 1.96; CI ¼ 5.04 to 1.11; aerobic exercise studies. Only two aerobic exercise studies were
I2¼; 96%; p ¼ 0.21). Relaxation training showed moderate entered for meta-analysis (Narin et al., 2003; Sertel et al., 2017)
effect on both pain intensity (Effect size ¼ 0.40; CI ¼ as the remaining were excluded because of lack of appropriate
0.76 to 0.03; I2¼; 0%; p ¼ 0.03), and disability level control group. Despite this a conclusive evidence was found.
(Effect size ¼ 0.42; CI ¼ 0.76 to 0.07; I2¼; 0%; p ¼ The range of the exercise duration per session as reported by
0.02). Finally, active and stretching exercises also had a mod- the included studies was 40–45 mins, the frequency was two to
erate effect on pain intensity of patients with headache (Effect five times weekly and all exercises lasted for 6 weeks to 3
size ¼ 0.41; CI ¼ 0.68 to 0.14; I2¼; 0%; p ¼ 0.003). months. Although we found many studies reporting aerobic
The remaining studies included in the sub-group pairwise exercises and there is consistency in their findings, the
meta-analyses per outcome were single studies. Nevertheless, design and conduct of the studies had tendencies for ROB,
the results indicated that some of the hands-off interventions and this accounted for the moderate evidence reached for
had either significant effect on either pain intensity or disabil- the intervention in our results. Improvement in disability
ity. The interventions include body awareness therapy and was supported by a weak evidence, which is insufficient for
anger awareness therapy, stress management, yoga, and body judgment, likewise sleep quality which has weak evidence
Figure 3. (A) Forest plot for pain intensity. (B) Forest plot for disability. (C) Forest plot for quality of life.
Mukhtar et al. 15
Figure 3. (continued).
indicating lack of improvement. Sleep quality is seldom slightly heterogeneous. For example, whereas three studies
reported in the headache studies, as only three out of the recruited migraine patients, one study recruited TTH, which
35 included studies measured sleep quality. might have also contributed in the QoL variations.
We found conflicting evidence concerning the QoL out- Active and stretching exercises of the head, neck and
come among the aerobic exercise studies. Four studies (Dittrich shoulder mostly resulted in weak evidence. However, this was
et al., 2008; Narin et al., 2003; E. Söderberg et al., 2006; mainly because there were no adequate studies on these types
Varkey et al., 2011) reported QoL and each of the studies used of exercises that permit strong judgment, nevertheless, the few
a different tool to assess the QoL, and these differences may studies under this category were well designed and with min-
have been a source of the results variation (Middel & Van imal risk of biases (two good quality and one fair quality stud-
Sonderen, 2002). For the exercise protocols, we did not notice ies). Moreover, meta-analysis found these exercises to
a lot of variations among the studies and the population was effectively reduce pain intensity.
Figure 3. (continued).
Behavioral/Cognitive Therapy (BT) our meta-analysis, BT was only marginally effective for both
pain intensity and disability. In the case of disability, the results
In this SR behavioral therapy comprising 10 studies resulted in
were highly heterogenous, which is contrary to the mixed-
conflicting/limited evidence concerning the effectiveness of
findings reported by Harris et al. (2015). Another potential
BT in improving pain, QoL, disability and sleep quality among
source of variations in the SR result may be related to the
headache patients. On the other hand, meta-analysis found BT duration of the intervention. Most of the studies did not report
to be marginally effective in reducing pain intensity and dis- the duration, frequency and the time frame for the intervention.
ability, but not quality of life. The conflict in the SR results of The few that reported, have a wide range of training duration
the BT studies is not likely to be associated with the studies’ with 20mins being the minimum training duration reported,
population because, all the 10 studies recruited migraine while 2 hours was the maximum. Additionally, intervention
patients, except in three studies that included migraine or TTH duration last for between 2 weeks to 3 months, which may
or both. The variation in the results may be related to the type also be a source of conflicts in the outcomes reported in this
of BT. Moreover, there was a high level of heterogeneity found review. Behavioral/cognitive therapy have for long been con-
among the studies reporting on behavioral/cognitive therapy in sidered the first-line preventive options and has been sug-
the meta-analysis. The method of BT was found to differ across gested the most effective non-pharmacological intervention
the studies. Some of the studies used web-based method for migraine and tension headache based on RCTs findings
(Bromberg et al., 2012; Devineni & Blanchard, 2005; Kleiboer (Nicholson et al., 2011), our meta-analysis has shown that the
et al., 2014; Sorbi et al., 2015), while some used a face to face efficacy may not be clinically substantial.
method and other studies used a self-home training method and
a previous meta-analysis has reported differences in outcomes
between web-based and non-web-based interventions in favor Relaxation Training
of web-based intervention for behavioral outcomes (Wantland Another frequently used hand-off intervention is relaxation
et al., 2004). This pattern might have contributed to the conflict training, which was reported in seven of the included studies.
in our SR results, as web-based and non-web-based BT were A strong evidence (SR) found that QoL was not improved after
not appraised separately. Additionally, corroborating our find- relaxation for headache patients, but it reduces disability and
ing is another previous review on CBT for headache, which pain intensity (moderate evidence). The reduction in pain
reported mixed findings (Harris et al., 2015). Interestingly, in intensity and disability following relaxation training was also
Mukhtar et al. 17
found following the meta-analysis. It is important to note that Implications

the studies focusing on quality of life were not suitable for
From the results of our SR and meta-analysis, several hands-off
meta-analysis. Hence, the strong evidence that was achieved
therapy methods are being used in the management of head-
meant that relaxation training did not improve QoL of head-
ache, which is an indication of the efforts put in by researchers
ache patients despite being reported by two good quality stud-
in finding effective alternative methods for treating headache.
ies (E. I. Söderberg et al., 2011; Varkey et al., 2011). No
Reports have shown that health-care is changing toward a
difference between relaxation groups and the comparing
greater involvement of the patients in their own care so that
groups were found probably because exercise training, acu-
clinicians’ contribution is reduced to increase the self-efficacy
puncture and topiramate (drug), that could be potentially effec-
of the patient (Peters et al., 2004) and the current evidence of
tive, were used as the control group instead of a wait-list/usual
our review has shown that active and autonomous therapies in
care/placebo control group. This limitation did not also permit
the form of aerobic exercises and relaxation training; and a
us to include the studies in the meta-analysis despite their good
passive therapy in form of pain education are likely to be
quality. Although not all the studies have reported the details of
successful for managing headaches. This is highly important
the relaxation training but some have used standard and cited
in chronic and more frequent medical conditions like headache
methods as reported by Larson and Daleflod (Jacobsen, 1929;
(Tyreman, 2005).
Schultz & Luthe, 1959), and Larson and Andrasik (Larsson &
From the current evidence of our review, hands-off thera-
Andrasik, 2002). A weak evidence was reported for the effect
pies like aerobic exercises and relaxation training showed the
of relaxation on sleep quality because only one study was
better promise for improving headache outcomes. Further stud-
available which was not suitable for meta-analysis. Moreover,
ies focusing on other hands-off therapies with sound methodo-
only few of the included studies of this review assessed sleep
logical quality are still needed to conclude on the topic area.
quality (Calhoun & Ford, 2007; Kanji et al., 2015; E. I. Söder-
berg et al., 2011).
Limitations
Avoidance, Coping and Stress Management The quality of the studies included varied and only nine of the
Four of the reviewed studies reported the effects of avoidance, included studies are of good methodological quality. Although
coping and stress management in the treatment of headache, the tool (Higgins et al., 2011) used to assess the methodological
however, these studies were not enough to permit conclusive quality of the studies is very critical, care has to be taken in
judgments in both narrative and quantitative synthesis. In interpreting these results. Also, many studies did not report data
general, most of the hands-off therapies were only scantily that will be suitable for meta-analysis. This also calls for the
reported. For example, avoidance and stress management need for more high quality and well-designed trials in the sub-
were represented by one study each, while coping was ject area going forward.
reported by two studies that resulted in two conflicting results Some studies were excluded from the review because they
which may be related to the difference in coping interventions reported pain index (headache index), which comprises of pain
given in the studies. severity, frequency and intensity rather than pain intensity.
Moreover, a recent review (Haywood et al., 2018) has recom-
mended headache frequency as a standard outcome for head-
Pain Education ache, but the findings were not available at the start of our
Pain education has a moderate evidence supporting its effec- review. To this extent, it may therefore be possible that, some
tiveness in reducing disability and a limited evidence that it studies reporting the effects of some hands-off therapy might
reduces pain intensity among headache patients. Although have been missed, if they reported only pain index or frequency
there is consistency in their findings, only two studies reported (did not report pain intensity or disability or QoL or quality of
this intervention and both were not suitable for meta-analysis. sleep as predefined in our PICOS). Sertel et al. (Sertel et al.,
Therefore, additional studies are still warranted. 2017), one of the included studies, did not report the gender
distribution of the study participants. However, when one of the
authors was contacted this was provided. This means we uti-
Other Interventions lized information outside what was published in the paper, but
Sauna and yoga were found to have weak evidence, because this has no effect on the results and conclusions of this review.
they were represented by single, although well designed (good No clear definition or a list of treatments that experts con-
quality), studies respectively. Lastly, a number of other inter- sider to be exclusively hands-off therapy exists. Therefore, all
ventions such as acceptance and commitment therapy, biofeed- treatments included in this review were considered hands-off
back exercises, guided imagery and Tai-Chi were graded as with the guidance of the two senior researchers in the study
limited evidence mainly because they were represented by just (MM and BC) who are experienced physiotherapists and have
one and poorly designed studies. All the studies in this category trained and mentored several other physiotherapists. Hence,
entered meta-analysis as a single study per intervention, which our interpretation of hands-off therapy might have led to exclu-
makes them unfit for conclusive judgments. sion of other relevant studies and or search databases. Lastly,
we categorized some interventions because of their similarity, Alvarez-Melcon, A., Valero-Alcaide, R., Atin-Arratibel, M., Melcon-
which simplifies the result presentation, but variations in the Alvarez, A., & Beneit-Montesinos, J. (2018). Effects of physical
interventions may exist within the same category which makes therapy and relaxation techniques on the parameters of pain in
the interventions not exactly the same. university students with tension-type headache: A randomised con-
trolled clinical trial. Neurologıá (English Edition), 33(4), 233–243.
Andersson, G., Lundström, P., & Ström, L. (2003). Internet-based
Conclusion treatment of headache: Does telephone contact add anything?
Based on our findings, current evidence seems to support the Headache: The Journal of Head and Face Pain, 43(4), 353–361.
use of hands-off therapy in the form of aerobic exercises and Baillie, L. E., Gabriele, J. M., & Penzien, D. B. (2014). A systematic
relaxation training for reducing pain intensity and disability review of behavioral headache interventions with an aerobic exer-
levels in patients with primary headache. However, no evi- cise component. Headache: The Journal of Head and Face Pain,
dence seems to support the use of hand-off therapy for improv- 54(1), 40–53.
ing quality of life of these patients. The evidence to support Bakhshani, N. M., Amirani, A., Amirifard, H., & Shahrakipoor, M.
other hands-off therapy interventions is limited by paucity of (2015). The effectiveness of mindfulness-based stress reduction on
studies (weak or limited evidence) or marginal efficacy. Nev- perceived pain intensity and quality of life in patients with chronic
ertheless, additional studies with better methodological quali- headache. Global Journal of Health Science, 8(4), 142–151.
ties are still needed for conclusive evidence for most of these https://doi.org/10.5539/gjhs.v8n4p142
interventions. Bakker, E. W., Verhagen, A. P., van Trijffel, E., Lucas, C., & Koes, B.
W. (2009). Spinal mechanical load as a risk factor for low back
Acknowledgments pain: A systematic review of prospective cohort studies. Spine,
Dr Jibril Mohammed is the recipient of a European Respiratory Soci- 34(8), E281–E293.
ety Fellowship in Guidelines Methodology (MTF 2019-01). Benoliel, R., Svensson, P., Evers, S., Wang, S.-J., Barke, A., Korwisi,
B., Rief, W., & Treede, R.-D. (2019). The IASP classification of
Declaration of Conflicting Interests chronic pain for ICD-11: Chronic secondary headache or orofacial
The author(s) declared no potential conflicts of interest with respect to pain. Pain, 160(1), 60–68.
the research, authorship, and/or publication of this article. Bhombal, S. T., Usman, A., & Ghufran, M. (2014). Effectiveness of
behavioural management on migraine in adult patients visiting
Funding family practice clinics a randomized controlled trial. Journal of
The author(s) disclosed receipt of the following financial support for the Pakistan Medical Association, 64(8), 900–906.
the research, authorship, and/or publication of this article: This Biondi, D. M. (2005). Physical treatments for headache: A structured
research did not receive any specific grant from funding agencies in review. Headache, 45(6), 738–746. https://doi.org/10.1111/j.1526-
the public, commercial, or not-for-profit sectors. 4610.2005.05141.x
Bishop, M. D., Bialosky, J. E., & Cleland, J. A. (2011). Patient expec-
ORCID iD tations of benefit from common interventions for low back pain
Naziru Bashir Mukhtar https://orcid.org/0000-0003-3965-0759 and effects on outcome: Secondary analysis of a clinical trial of
manual therapy interventions. Journal of Manual & Manipulative
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Review

Evaluation & the Health Professions

Naziru Bashir Mukhtar1,2 , Mira Meeus1,3,4, Ceren Gursen5, Jibril Mohammed2,

Background Roth, 2015). The treatment approaches of headache mainly

CG (Manual therapy): 20; 6_,

Records aer duplicates removed

Records screened Records excluded

Full-text arcles excluded based on

Studies included in qualitave synthesis

Data not appropriate for MA =7

found following the meta-analysis. It is important to note that Implications

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