Complementary Therapies in Medicine (2008) 16, 139—146

available at www.sciencedirect.com

journal homepage: www.elsevierhealth.com/journals/ctim

Acupuncture for acute non-specific low back

pain: A pilot randomised non-penetrating
sham controlled trial
S. Kennedy a, G.D. Baxter b, D.P. Kerr a, I. Bradbury a,
J. Park c, S.M. McDonough a,∗

a
Health and Rehabilitation Sciences Research Institute, School of Health Sciences, University of Ulster,
Northern Ireland, United Kingdom
b
Centre for Physiotherapy Research, School of Physiotherapy, University of Otago, New Zealand
c
Division for Research and Education in Complementary and Integrative Medical Therapies, Harvard Medical School,
Osher Institute, USA
Available online 27 April 2007

KEYWORDS Summary
Acupuncture; Objective: A pilot study to assess the feasibility of a trial to investigate the efficacy of acupunc-
Acupuncture therapy; ture compared to placebo needling for the treatment of acute low back pain (LBP). As part of
Low back pain; this, the study was designed to establish the credibility of the placebo control, and to provide
Backache; data to inform a power analysis to determine numbers for a future trial.
Non-penetrating Study design: A pilot patient and assessor blinded randomized controlled trial.
sham control; Setting: Primary care health centre facility, South and East Belfast Trust, Northern Ireland.
Placebo; Patients: Patients from the physiotherapy waiting list (n = 48) with LBP of less than 12 weeks
Randomized duration.
controlled trial; Outcome measures: Roland and Morris Disability Questionnaire (RMDQ), Visual Analogue Scale
Blinding; (VAS), medication use and an exit questionnaire were completed at baseline, end of treatment,
Pilot study and at 3 months follow up.
Results: Ninety-four percent (45/48) of patients completed assigned treatment, 83% (40/48)
completed 3 months follow-up. The sham needle used here proved to be credible: 91.7% in
the placebo group believed they had received acupuncture, compared to 95.8% in the verum
acupuncture group. Differences in baseline characteristics were accounted for using ANCOVA.
There was no significant difference between groups on the RMDQ over time. For pain, the only
statistically significant difference was at the 3 months follow up (worst VAS, point estimate,
18.7, 95% CI 1.5—36.0, p = 0.034). The majority of patients were taking some form of analgesic
medication for LBP at the start of treatment (n = 44; 92%), and at the end of treatment the
verum acupuncture group were taking significantly fewer tablets of pain control medication
(mean (S.D.): 1.0 ± 0.3) than the placebo group (mean (S.D.): 4.2 ± 0.6, p < 0.05). Based upon

∗ Corresponding author. Tel.: +44 2890366459; fax: +44 2890368068.

E-mail address: s.mcdonough@ulster.ac.uk (S.M. McDonough).

0965-2299/$ — see front matter © 2007 Elsevier Ltd. All rights reserved.
doi:10.1016/j.ctim.2007.03.001
140 S. Kennedy et al.

these data, power analysis (power = 90%, alpha = 0.05, minimal clinically important difference
(MCID) for RMDQ = 2.5 points) indicated that 120 participants (60 per group) would be needed to
complete an adequately powered randomized controlled trial.
Conclusions: This study has demonstrated the feasibility of a randomized controlled trial of
penetrating needle acupuncture compared to a non-penetrating sham for the treatment of acute
LBP in primary care; 120 participants would be required in a fully powered trial. The placebo
needle used in this study proved to be a credible form of control.
© 2007 Elsevier Ltd. All rights reserved.

Introduction Inclusion criteria

Adults able to give informed consent, males and females
An unresolved question concerning acupuncture is whether aged 18—70 years. Current episode of non-specific LBP, with
there is a specific effect attributable to the needling proce- or without referred pain, of up to 12 weeks duration. LBP
dure itself1 ; to address this issue requires trials using valid was defined as pain localised below the lowest ribs, and
sham (placebo) controls.1,2 above the inferior gluteal folds, with or without radiation
Several non-penetrating needles have been developed to the lower extremities.12
(i.e. The Streitberger needle and The Park Sham Device),
which have both been shown to be credible and valid con- Exclusion criteria
trols for acupuncture trials.3—7 To date, no studies have Pain lasting more than 12 weeks. Presentation of red flags
assessed their potential utility in trials for low back pain as defined by the Clinical Standards Advisory Guidelines13 ;
(LBP). contra-indications to acupuncture or previous acupuncture
Two recent systematic reviews have highlighted the lack treatment; conflicting or ongoing treatment.
of research to support the use of acupuncture in acute LBP,
and the need for more well-controlled trials in such an Clinical interventions
under-researched area.8,9 A full conventional clinical assessment was carried out
Therefore, the aim of this study was to test the feasibil- at first attendance by the treating therapist to ensure
ity of a randomized controlled trial to compare the efficacy the patient fulfilled the inclusion criteria. Patients were
of verum acupuncture to a non-penetrating sham needling requested to continue normal activities, and to avoid other
control in acute LBP. Specific objectives were first to provide forms of treatment for the duration of the study, apart
necessary data upon which to base a power analysis and from routine physician management and analgesics. Patients
secondly to assess the credibility of the proposed placebo were informed that they may or may not receive acupunc-
needle. ture as part of their treatment; none had previously received
acupuncture. Therapists were not permitted to use any
Methodology treatments other than those in the designated protocol; all
treatment records were available in order to verify adher-
Study design ence to the protocol.
Both verum and sham controlled treatments were per-
This was a pilot (feasibility) study10,11 for a patient and formed by the same senior experienced physiotherapists
assessor blind randomised controlled trial. Subjects were (n = 3); each had a minimum of 10 years clinical experience,
randomly allocated into groups using a computer generated and were members of the Acupuncture Association of Char-
randomization table (http://www.randomization.com). To tered Physiotherapists (AACP).14 Patients were allocated to
ensure concealment of allocation, an administrative assis- the therapists in sequence so that equal numbers of patients
tant not otherwise involved in the study held the were allocated to each therapist.
randomization list. Verum acupuncture. Acupuncture style was based on a
western medical approach: unilateral or bilateral points
were chosen to effect analgesia according to the patient’s
Ethical considerations pattern of pain.15 Each therapist chose points from a
set range commonly used in LBP (based on review of
Ethical approval was gained from the Queens Univer- textbooks,16—21 RCTs22,23 ; confirmed by local expert opinion);
sity Belfast Research Ethics Committee, Northern Ireland. see Table 1.
Approval was also gained from South and East Belfast Trust Patients were treated in prone lying and received a min-
where the trial was completed. imum of three and a maximum of 12 treatments over a
4—6 weeks period. Frequency of treatment was once or
Subjects twice a week depending on symptom severity, and availabil-
ity of appointments, and was determined by the treating
Patients currently on the waiting list for physiotherapy therapist. Within each treatment the therapist inserted
through referral by their general practitioner (GP) were con- 8—13 needles which were stimulated manually every 5 min
tacted by telephone and screened for inclusion in the study. until subjective acupuncture specific sensation or de qi
Acupuncture for acute low back pain 141

Table 1 Acupuncture points

Acupuncture Location Method of insertion

points

GV3 Below spinous process 4th lumbar vertebra Perpendicular 0.5—1 in.
GV4 Below spinous process 2nd lumbar vertebra Perpendicular 0.5—1 in.
BL23 1.5 cun lateral to lower border of spinous process 2nd Perpendicular 1—1.5 in.
lumbar vertebra
BL25 1.5 cun lateral to lower border of spinous process 4th Perpendicular 1—1.5 in.
lumbar vertebra, level with iliac crest
GB29 Midway between ASIS and greater trochanter Perpendicular 0.5—1 in.
GB30 Junction of middle and lateral third of the distance Perpendicular 2—3 in.
between great trochanter and sacral hiatus
GB31 Midline lat aspect thigh (tip of middle finger) Perpendicular 0.7—1.2 in.
GB34 In the depression anterior and inferior to fibula head Perpendicular 1—1.5 in.
BL36 Middle of transverse gluteal fold Perpendicular 0.7—1.5 in.
BL37 6 cun below BL36 Perpendicular 0.7—1.5 in.
BL40 Middle of transverse crease popliteal fossa Perpendicular 0.5—1.5 in.
BL56 Centre of belly of gastrocnemius Perpendicular 0.5—1.5 in.
BL60 Depression between lateral malleolus and TA Perpendicular 0.5 in.

was achieved, or for 30 s using an even technique. Nee- Outcome measures and follow-up procedures
dle retention time was 30 min per treatment. The Park
Sham Device (AcuPrime, UK) with verum acupuncture nee- A range of outcome measures were used as recom-
dles were used (Spring and Scarborough, Wujiang jia chen mended by Bombardier26 : these included questionnaires
Acupuncture Devices Co. Ltd.; sterile single use needles with proven psychometric properties for LBP-specific
with guide tube, size 0.25 mm × 40 mm) to maintain patient functional disability26—28 (Roland and Morris Disability Ques-
blinding. tionnaire, RMDQ) and pain29 (Visual Analogue Scale, VAS),
Control intervention. The same Park Sham Device and a multidimensional patient-centred questionnaire (work
(AcuPrime, UK) was also used in the control group, so absenteeism, analgesic medication consumption, additional
that patients were blinded to treatment5,7 ; however in healthcare). These were completed at baseline, discharge,
this group non-penetrating sham needles were used which and 3 months (by post). An exit questionnaire which assessed
touched but did not penetrate the skin (sterile single use patient satisfaction, success of blinding, and evaluated the
needles with guide tube, size 0.3 mm × 40 mm, AcuPrime, credibility of the placebo was also completed by each
Dong Bang Acupuncture Inc, Korea). The same acupuncture patient at the end of treatment.
points and clinical protocol was followed for the control
as for the verum acupuncture group to ensure the same
therapeutic experience. Data analyses
Co-interventions. Clinical guidelines recommend advice to
remain active and medication as routine care for acute All variables were analysed using the Statistical Package
LBP.13,24 Advice was standardised at the first treatment by for the Social Sciences (SPSS) version 11. Intention-to-treat
giving all participants the Back Book, an evidence-based analysis was carried out by an investigator who was masked
booklet, developed for use by patients with LBP.25 Medica- to treatment allocation. Any missing data were replaced
tion intake was not controlled and may have been prescribed by carrying forward the most recent non-missing value.
by the referring physician or obtained over the counter by Analysis of covariance (ANCOVA), using pretreatment value
the patient. Medication intake was recorded at initial assess- as the covariate, was used to determine any differences
ment and patients were asked to complete a daily diary between the groups at the post-treatment and follow-up
to record the type of medication, the dose in mg and the visits. Exploratory analysis was carried out using numbers
number taken per day. of treatments as an additional covariate, and the numbers
Blinding. Given the nature of the treatments, it was pos- of treatments between the groups was compared using the
sible to blind subjects but not therapists with respect to Mann—Whitney test. Analgesic intake between the groups
the content of the interventions. The success of patient was compared using the Van Elteren test, which is a modifi-
blinding was assessed at the end of treatment. The primary cation of the Mann—Whitney test that accounts for baseline
researcher, who was unaware of patient allocation until the differences.30 Because of doubts about the appropriateness
completion of the data analysis, carried out data collection of parametric ANCOVA for medication usage, the baseline
at all time points. medication usage was grouped into four categories using
Compliance and drop-outs. Non-compliance was defined quartile cut-points (category 1: 0—25% = 0—2 tablets, cat-
as receipt of less than three treatments, but such patients egory 2: 25—50% = 3—4 tablets, category 3: 50—75% = 5—8
were included in subsequent follow-ups for the purposes of tablets and category 4: 75—100% = 9—15 tablets). The result-
intention-to treat analysis. ing categories were used as baseline scores in a Van Elteren
142 S. Kennedy et al.

test to compare post-treatment medication usage between

Table 2 Baseline characteristics
groups.
Data from the exit questionnaire were analysed using Sham Acupuncture p value
Mann—Whitney tests to establish any differences between group group
groups. A power analysis was completed using a between
group minimal clinically important difference (MCID) of 2.5 Age
points for the RMDQ,31 at an alpha of 0.05 and power of 90%. Mean 44.6 46.5 0.50
S.D. 10.8 11.4

Results Sex (%)

Males 41.7 54.2 0.56
Forty-eight patients were recruited and randomized into Females 58.3 45.8
groups: see Fig. 1.32 Outcome data were obtained from 94% Pain distribution (%)
of participants at the end of treatment; at 3 months follow Referred pain 46 50 1.00
up this had reduced to 83%. Reasons given for not complet- Simple back pain 54 50
ing treatment were: no benefit gained, no time available,
and work commitments. Work status (%)
Employed 45.8 54.2 0.20
Sick leave 20.8 29.2
Outcome measures Unemployed 16.7 4.2
Homemaker 12.5 8.3
Table 2 shows distribution of age, gender, pain distribution, Retired 4.2 4.2
work status, days off work and medication intake, whilst
Table 3 shows baseline values for all outcome measures. No Health care usage (%)
significant differences between the two groups were iden- GP 83.3 66.7 0.47
tified; however the placebo group had higher scores on VAS Private physiotherapy 8.3 4.2
and RMDQ at baseline, thus supporting the use of ANCOVA Chiropractor/osteopath 4.2 20.9
analysis. CAM 4.2 8.4

Figure 1 The flow of the trial according to the CONSORT statement.32

Acupuncture for acute low back pain 143

Table 3 Outcome measure scores expressed as mean ± S.E.M. values

Verum acupuncture (mean ± S.E.M.) Sham acupuncture (mean ± S.E.M.)

Baseline End of 3 months Baseline End of 3 months

treatment follow up treatment follow up

RMDQ 12.7 ± 1.1 6.0 ± 1.0 5.0 ± 1.0 12.8 ± 1.1 7.0 ± 1.3 7.7 ± 1.5
VAS average 56.2 ± 5.7 27.3 ± 4.9 26.5 ± 5.2 62.6 ± 4.0 36.3 ± 6.1 40.7 ± 6.2
VAS worst 76.4 ± 4.7 40.71 ± 6.1 33.3 ± 5.7 73.8 ± 4.1 52.5 ± 6.1 51.7 ± 5.8
Days off work 11.1 ± 4.5 13.9 ± 5.3 — 7.5 ± 2.3 10.9 ± 4.1 —
Medication intake (tablets per day) 4.2 ± 0.6 1.0 ± 0.3 — 5.3 ± 0.8 4.2 ± 0.6 —

The estimated marginal mean differences in all outcome group (4.2 ± 0.6). This difference remained significant after
measures at the end of treatment and follow up (adjusted allowance for pretreatment differences in medication usage
for baseline values) are summarized in Table 4. There was (p < 0.05, Van Elteren test).
no significant difference between groups on the RMDQ over Patients received a mean of 5.7 treatments. There was
time. a significant difference between groups in the number of
Pain was measured as average pain and worst pain. There treatments received (Mann—Whitney test, p = 0.001). The
was no significant difference between groups at the end of acupuncture group received more treatments (6.3 ± 1.5;
treatment for average pain or worst pain (p > 0.05); how- mean ± S.D.): 11 patients in this group received more than
ever, at follow up there was a trend towards a greater six treatments, compared to none in the placebo group
analgesic effect for average pain in the verum acupuncture (5.2 ± 1.4). In exploring the effect of this on each outcome
group (average VAS: estimated marginal mean difference measure there was only weak evidence (p = 0.075) for a posi-
from baseline, 10.6, 95% CI −0.41 to 25.3, p = 0.152). In the tive relationship between RMDQ at the follow-up period and
case of worst pain, such differences were found to be sta- the number of treatments received; however allowance for
tistically significant at the 3 months follow up (worst VAS: this by using the number of treatments as a covariate in the
estimated marginal mean difference from baseline, 18.7, analysis did not substantially affect the conclusions.
95% CI 1.5—36.0, p = 0.034).
Results for medication intake showed that the majority
of patients were taking some form of analgesic medica- Power analysis
tion for LBP at the start of treatment (n = 44; 92%). At
the end of treatment, subjects in the verum acupuncture The current data were used to calculate numbers required
group were taking significantly fewer doses (tablets per day) to detect significant differences for pain (average VAS) and
of medication (1.0 ± 0.3; mean ± S.E.M.) than the placebo RMDQ between groups. For average pain, using an estimated

Table 4 This table shows the estimated marginal mean values for verum and placebo acupuncture adjusted for the initial
baseline score for each outcome measure, and the between-group difference values plus statistical analyses of these values

Verum Placebo Placebo-verum Statistical analysis of

between group
differences (p value)
Estimated marginal Estimated marginal Estimated marginal
mean mean mean between-group
differences

RMDQ end of treatment 6.1 ± 1.0 7.0 ± 1.0 0.9 ± 1.4 0.504
95% CI, 5.0—8.9 95% CI, 4.1—8.0 95% CI, −1.8—3.7
3 months 5.1 ± 1.2 7.7 ± 1.2 2.6 ± 1.6 follow up 0.119
95% CI, 2.7—7.4 95% CI, 5.3—10.0 95% CI, −0.7—5.9
VAS average end of treatment 28.8 ± 5.2 34.9 ± 5.2 6.1 ± 7.4 0.12
95% CI, 18.3—39.2 95% CI, 24.4—45.3 95% CI, −8.7—20.9
3 months 28.3 ± 5.1 38.9 ± 5.1 10.6 ± 7.3 0.152
95% CI, 17.9—38.6 95% CI, 28.5—49.2 95% CI, −4.1—25.3
VAS worst end of treatment 40.4 ± 6.1 52.8 ± 6.1 12.5 ± 8.6 0.152
95% CI, 28.2—52.5 95% CI, 40.7—65.0 95% CI, −4.8—29.7
3 months 33.1 ± 6.1 51.8 ± 61 18.7 ± 8.6 0.034
95% CI, 20.8—45.3 95% CI, 39.6—64.0 95% CI, 1.5—36.0
Significant differences between groups are in bold for worst VAS, the acupuncture group demonstrated significant hypoalgesia at follow
up.
144 S. Kennedy et al.

Table 5 Exit questionnaire Table 5 ( Continued )

Placebo Acupuncture Statistics Placebo Acupuncture Statistics

group (%) group (%) (n) (p value) group (%) group (%) (n) (p value)
(n) (n)

Treatment receiveda I was given a chance to ask questions

Acupuncture 91.7 (22) 95.8 (23) 1.0 Strongly disagree 4.5 (1) 0.012
Advice 41.7 (10) 66.7 (16) Disagree
Uncertain 36.4 (8) 8.7 (2)
I would have it again
Agree 59.1 (13) 91.3 (21)
Strongly disagree 0.031
Strongly agree
Disagree
a Patients were asked whether they had received acupuncture
Uncertain 13.6 (3) 17.4 (4)
Agree 31.8 (7) 82.6 (19) yes/no; or whether they had received advice yes/no.
Strongly agree 54.5 (12)
I would recommend it to others within group S.D. of 30 points, an MCID between groups of
Strongly disagree 0.068 20, alpha of 0.05 and power at 90%, a total of 56 subjects (28
Disagree in each arm) would need to be recruited. For RMDQ, using
Uncertain 9.1 (2) 17.4 (4) the same power and alpha level, an estimated within group
Agree 31.8 (7) 82.6 (19) S.D. of four points, and an MCID between groups of 2.5, a
Strongly agree 59.1 (13) total of 120 subjects (60 in each arm) would be needed.

Overall I was satisfied with my care

Credibility of placebo acupuncture
Strongly disagree 0.066
Disagree
Results of the exit questionnaire are summarised in Table 5.
Uncertain 4.5 (1) 13.0 (3)
All patients who offered an opinion (22 placebo group,
Agree 31.8 (7) 87.0 (20)
23 verum group) believed they had received acupuncture,
Strongly agree 63.6 (14)
supporting the credibility of non-penetrating sham acupunc-
I didn’t recover as well as I hoped ture.
Strongly disagree 27.3 (6) 30.4 (7) 0.747
Disagree 40.9 (9) 39.1 (9) Discussion
Uncertain 9.1 (2) 13.0 (3)
Agree 18.2 (4) 17.4 (4)
Results from this study indicate that a larger trial would
Strongly agree 4.5 (1)
require 60 participants in each arm in order to have the
Physiotherapy was a complete waste of time power to demonstrate statistically significant changes in
Strongly disagree 54.5 (12) 82.6 (19) 0.035 both pain and function in acute LBP. Return to function is
Disagree 36.4 (8) 17.4 (4) of primary importance in LBP and should be considered the
Uncertain 9.1% (2) main outcome in a fully powered trial. To calculate this value
Agree we used an RMDQ between group difference value of 2.5
Strongly agree points as recommended by Roland and Fairbanks31 and an
I enjoyed coming for physiotherapy S.D. of four points derived from our pilot data.
Strongly disagree 4.5 (1) 0.244 This study has also demonstrated the feasibility of a
Disagree 4.3 (1) methodologically rigorous, sham-controlled trial in a clin-
Uncertain 68.2 (15) 8.7 (2) ically appropriate setting (a busy hospital outpatient clinic)
Agree 27.3 (6) 34.8 (8) using a typical group of patients with acute LBP. Acupuncture
Strongly agree 52.2 (12) intervention was carried out as part of the normal workload
of treating physiotherapists, and patients accepted comple-
I feel she listened to what I had to say tion of a range of validated outcome measures with minimal
Strongly disagree 4.5 (1) 0.006 drop out at the 3 months follow up (placebo 12%; verum 4%).
Disagree In a main trial we would anticipate recruiting multiple phys-
Uncertain 40.9 (9) 8.7 (2) iotherapy departments across Northern Ireland but would be
Agree 54.5 (12) 91.3 (21) more prudent and estimate a drop out of 20%.
Strongly agree Finally this study is the first to use the Park Sham
I was given good advice about my back Device in acute LBP patients, and thus adds to the valid-
Strongly disagree 4.5 (1) 0.052 ity already demonstrated in healthy adults and those with
Disagree stroke.5,7 Furthermore verum acupuncture produced a clin-
Uncertain 27.3 (6) 8.7 (2) ically important (for pain and function33,34 ) and statistically
Agree 68.2 (15) 91.3 (21) significant (for worst pain) analgesic effect compared to
Strongly agree non-penetrating sham acupuncture, at 3 months follow up.
Coupled with this effect was a significant reduction in med-
ication intake for the verum group over the course of
Acupuncture for acute low back pain 145

treatment. No significant effects were observed for func- placebo-acupuncture for postoperative nausea and vomiting
tion, although there was a trend for a greater (clinically prophylaxis: a randomized placebo-controlled patient and
important) improvement in the verum group at follow up. observer blind trial. Anaesthesia 2004;59:142—9.
Previous studies have been unable to disentangle spe- 7. Park J, White AR, James MA, Hemsley AG, Johnson P, Cham-
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sham controlled, subject- and assessor-blind, randomised trial.
used penetrating needles23,35,36 which may produce physi-
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