Complementary Therapies in Medicine (2009) 17, 131140

available at www.sciencedirect.com

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

Different frequencies of acupuncture treatment for

chronic low back pain: An assessor-blinded pilot
randomised controlled trial
Jing Yuan a, Nithima Purepong a, Ruth Fiona Hunter a, Daniel Paul Kerr a,
Jongbae Park b, Ian Bradbury c, Suzanne McDonough a,
a

School of Health Sciences, University of Ulster, Shore Road, Co Antrim, BT37 0QB, United Kingdom
Department of Physical Medicine and Rehabilitation, University of North Carolina at Chapel Hill, CB7200, NC, USA
c
Frontier Science (Scotland) Ltd, Grampian View, Kincraig, Inverness-shire PH21 1NA, United Kingdom
Available online 4 January 2009
b

KEYWORDS
Acupuncture;
Low back pain;
Randomised
controlled trials;
Frequency

Summary
Objectives: To examine the feasibility of a main RCT to compare the effectiveness of two
frequencies (2 versus 5 times/week) of acupuncture treatment for chronic low back pain (LBP).
Methods: Participants (n = 30) with chronic LBP were randomised into two groups to receive
10 acupuncture treatments: Low Frequency Group, 2 times/week for ve weeks (n = 15); High
Frequency Group, 5 times/week for two weeks (n = 15). The following outcomes were measured
blindly at baseline, 2 weeks, 5 weeks, 3 months and 1 year: pain on a VAS, functional disability
using the RMDQ, quality of life using the Measure Yourself Medical Outcome Prole (MYMOP-2),
psychological impact with the Coping Strategies Questionnaire (CSQ) and Pain Locus of Control
(PLC) questionnaire. Two objective outcomes, the Shuttle Walk Test (SWT) and Lateral Trunk
Flexibility (LTF), were also measured.
Results: The compliance rate was 100% for each group. Some of the measurements were shown
to be sensitive (VAS, RMDQ, MYMOP-2 Wellbeing). 66330 participants would be required for
a fully powered non-inferiority trial. The groups were balanced at baseline for LBP and demographic characteristics. There were no signicant differences between the groups in terms of
any of the outcomes, at each follow-up time point. It was notable however that the clinically important improvement in terms of pain, functional disability, quality of life, and SWT
in both groups was achieved within the rst two weeks, which was maintained at one year
follow-up.
Conclusions: It is feasible to conduct a main RCT, to compare different frequencies of acupuncture for LBP, using sensitive measurements. Also the trend for early clinically important
improvement within a minimum of four measurements is worthy of further study.
2008 Elsevier Ltd. All rights reserved.

Corresponding author at: 1F125, Health & Rehabilitation Sciences Institute, University of Ulster, Jordanstown, Shore Road, CO. Antrim,
Northern Ireland BT37 0QB, United Kingdom. Tel.: +44 2890 366459; fax: +44 2890 368419.
E-mail address: s.mcdonough@ulster.ac.uk (S. McDonough).

0965-2299/$ see front matter 2008 Elsevier Ltd. All rights reserved.
doi:10.1016/j.ctim.2008.10.003

132

Introduction
Acupuncture has gained popularity in the West as a
complementary and alternative therapy,1 and numerous randomised controlled trials (RCTs) have been conducted to test
its effectiveness. Low back pain (LBP) is the most common
reason for visits to acupuncturists,2,3 and up to 2007 more
than 20 RCTs in English has been conducted on acupuncture
for LBP.4,5 However, great variation in acupuncture treatment parameters has emerged in these RCTs,4,6 with little
consensus on the optimal choice of parameters.712,15 Previous systematic reviews have shown that the effectiveness
of physiotherapeutic interventions is entirely dependent on
the treatment parameters or dosage employed,13,14 therefore suggesting that further exploration of the dosage of
acupuncture treatment might be important to guide clinical
management of LBP patients.
According to a systematic review on acupuncture treatment parameters for LBP, two extremes of treatment
frequency for LBP were reported between textbooks, clinical practice and clinical studies, i.e. 12 time/week versus
56 times/week.15 Though it may be assumed that more
frequent treatment might lead to greater effects, this is
not in accordance with the study by Ceccherelli16,17 which
suggested that acupuncture was more successful when given
once weekly than twice weekly, for a total of 10 sessions.
Due to the lack of trials addressing the question of
acupuncture treatment frequency, the current pilot study
has examined the feasibility of conducting a trial to explore
two frequencies (2 times/week versus 5 times/week) of
acupuncture for LBP. The specic objectives were:
i. To assess attendance adherence for daily versus twice
weekly sessions.
ii. To evaluate the appropriateness of the outcome measures.
iii. To complete a power analysis.

Materials and methods

Selection of participants
This pilot study was conducted at the University of Ulster
clinic, from September 2005 to March 2007. Ethical permission was obtained from the Ofce for Research Ethics
Committee, Northern Ireland (ORECNI). Participants with
chronic non-specic LBP were recruited through the e-mail
system and poster advertisements in the University, and
screened using a LBP Examination Form and Participant
History Sheet, based on the strict inclusion and exclusion criteria listed below. Non-specic LBP was dened as
pain below the 12th costal margin and above the inferior
gluteal folds, with or without radiating leg pain, for which
specic etiologies such as infection, tumor, osteoporosis,
fracture, structural deformity, inammatory disorder, radicular syndrome or cauda equina syndrome and other relevant
pathological entities had been excluded.18 The nature of
the treatment was explained in the Participant Information Sheet before each participant was required to give
written informed consent. Screening of all participants was
carried out by a qualied musculoskeletal physiotherapist

J. Yuan et al.
Inclusion, exclusion and withdrawal criteria.
Inclusion criteria
1.
Non-specic chronic LBP (3months) as the chief
complaint, with or without leg pain
2.
Aged between 1860 years and of both genders
Exclusion criteria
1.
History of disc or spine surgery
2.
Sciatica
3.
Neurological disorders and possible serious
pathological back problem
4.
Systemic bone or joint disorders (e.g. rheumatoid
arthritis)
5.
Pregnancy
6.
Dementia
7.
Severe clotting disorders or anticoagulant therapy
8.
Epilepsy
9.
Systemic or visceral disease
10.
Current use of systemic corticosteroids, muscle
relaxants, narcotic medications
11.
Overt psychiatric illness
12.
Received acupuncture treatment within the past 6
months
13.
Unemployed or having current/pending
compensation claims
14.
Other acute orthopaedic or medical problems

who determined, by subjective and objective examination,

whether the patient had non-specic LBP.

Sample size
This study was considered a preliminary study in preparation
for a main RCT, therefore a sample size of 40 participants
(20 per group) was considered appropriate and achievable
on the basis of the time allocated for participant recruitment, treatment and follow-up. The recruitment target was
10 participants per month over a four-month time period.

Randomisation
Allocation was concealed from the screening physiotherapist who determined eligibility of participants for entry
into the trial. Participants were randomly allocated into two
treatment groups, using a computer-generated random allocation sequence and sealed opaque envelopes which were
opened by the acupuncturist before treatment started. The
Low Frequency Group received treatment 2 times/week for
ve weeks (n = 15); and the High Frequency Group received
treatment 5 times/week for two weeks (n = 15).

Acupuncturist
Participants were treated by two acupuncturists with more
than ve years clinical experience in acupuncture.

The Back Book

All participants received the Back Book,19 a readily acceptable and understandable, evidence-based patient education

Different frequencies of acupuncture treatment for chronic low back pain

133

booklet, as a co-intervention, from their treating acupuncturist, which encouraged patients to keep as active as
possible,20 as recommended by the European guidelines,18
the Clinical Standards Advisory Group,21 and the Royal College of General Practitioners.22

RMDQ,2729 1.0/6.0 point reduction on MYMOP-2,30,31 and

25.0m improvement on SWT,32 however, previous studies
have not dened a MCID for the subscales of CSQ, PLC and
LTF. Total completion time for all self-administered questionnaires was approximately 30 min.

Materials and needling procedure

Data analysis

All of the acupuncture instruments were supplied by

Scarboroughs Ltd in the United Kingdom (UK). Filiform
needles were single use, sterile, copper handled, and prepacked with guide tubes. Sizes (Diameter Length) were
0.25 mm 25 mm, 0.25 mm 50 mm and 0.25 mm 75 mm.
The sizes of glass cups were 66 mm, 55 mm and 45 mm (D),
and the size of the smokeless moxa rolls (mainly made of
ve types of Chinese herbs) was 13 mm 120 mm (D L).
A total of 10 treatment sessions were administered to
each participant. Points were chosen individually for each
participant, either according to traditional Chinese medical (TCM) principles or segmental/extra segmental/trigger
point principles. The mean number of needles inserted
for each participant in each session ranged from three to
twelve. The needles were manually stimulated by rotating,
thrusting, stirring, etc. to produce De Qi sensation, and
then left for 2030 min. The participants were checked at
10 min intervals to ensure De Qi was still being felt with
a view to re-stimulate if necessary. Manipulation was performed by using rotation and/or thrust or twirling. Because
moxibustion and cupping are generally used by TCM practitioners to improve the effectiveness of acupuncture, which
could be regarded as a component of traditional Chinese
acupuncture,11,15 they were applied as supplementary therapy to needling in the trial if necessary.

All data were analysed using the SPSS software (version

15.0) according to the intention-to-treat principle. A Complete Case Analysis was undertaken using Listwise deletion
and then repeated using Imputation Analyses whereby missing values were replaced with imputed values generated
by the expectation maximisation (EM) algorithm method.33
Participant characteristics and the outcome measure questionnaire data at baseline were compared using 2 tests
for discrete nominal variables and T-tests or MannWhitney
U tests for continuous variables. The normal distribution
of the continuous variables was checked using both Box
Plots and the Shapiro-Wilks test. For the outcome measures
at discharge (i.e. two weeks for groups of 5 times/week
treatment and ve weeks for groups of 2 times/week treatment, respectively) or each follow-up time point (2 weeks,
5 weeks, 3 months, 1 year), between-within repeatedmeasures ANCOVA assessed signicant differences between
groups over time using the relevant baseline scores as the
covariate, if the assumptions for parametric statistics held
(otherwise the MannWhitney U test was used). For all
comparisons, a probability of < 0.05 was considered to be
statistically signicant (two-tailed). In addition, power analysis for a non-inferiority trial was completed using an alpha
of 0.05 and power of 90%.

Compliance
Based on ndings from previous studies,15,23 it was determined that participants should receive a minimum of four
and a maximum of 10 treatments in total. Non-compliance
was dened as participants receiving three or less treatments, who were included in all subsequent follow-ups for
the purposes of intention-to-treat analysis.

Outcome measures

Effect size
The treatment effect size was calculated as point estimates
for each time point, i.e. standardised mean difference (SMD)
at two weeks, ve weeks, three months and one year, in a
random-effect model, each with corresponding 95% condence intervals (95% CI). The formula is shown below:
SMD = (Mean in the High Frequency acupuncture group
Mean in the Low Frequency acupuncture group)/
Pooled SD of both groups.

An independent blinded investigator measured the outcomes by interview at the initial visit and then at 2 and 5
weeks after the initial treatment, and 3 months and 1 year
after the end of the treatment. A series of valid and reliable
outcome measures were used to assess the different aspects
of factors related to LBP. There were four subjective measures completed by participants independently: pain (VAS,
Visual Analogue Scale), functional disability (Roland-Morris
Disability Questionnaire, RMDQ), quality of life (Measure
Yourself Medical Outcome Prole, MYMOP-2), psychological impact (Coping Strategies Questionnaire, CSQ; Pain
Locus of Control, PLC), and two objective measures (Shuttle Walk Test, SWT and Lateral Trunk Flexibility, LTF). If
available, minimal clinically signicant differences (MCID)
in these outcomes measures were dened as a 2.0 cm
reduction (of 10 cm) on VAS,2426 2.5 points reduction on

Results
Participant ow is shown in Fig. 1. From September
2005 to March 2006, a total of 30 participants were
recruited and randomised into two groups: Low Frequency
Group, 2 times/week (n = 15; 9 male, 6 female; age,
mean SD = 43.53 9.67 years); High Frequency Group, 5
times/week (n = 15; 9 male, 6 female; age, mean SD =
43.87 10.45 years) (Table 1).
Participants who failed to attend for at least four
treatments were considered non-compliant with the study
protocol, this did not occur, therefore the compliance rate
was 100% for both groups (Fig. 1). The average number

134

J. Yuan et al.

Figure 1

Table 1

Patient ow through the trial.

Baseline demographic and clinical characteristics of patients.

Male (%)
Age (yrs) (mean, SD)
Height (cm) (mean, SD)
Weight (kg) (mean, SD)
LBP duration (yrs) (mean, SD)
LBP with leg pain (%)
Patients employed (%)
Medication taking (%)

2 times/wk (n = 15)

5 times/wk (n = 15)

60
43.53
169.75
78.32
14.18
87
7
33

60
43.87
168.28
76.51
10.77
100
13
20

1.000
0.928
0.695
0.784
0.370
0.143
0.543
0.409

(9.67)
(10.32)
(17.11)
(10.72)

(10.45)
(9.95)
(18.67)
(9.81)

Overall T-tests (or non-parametric equivalent, the MannWhitney U test), or 2 tests for nominal variables, were not statistically
signicant (T P = 0.05).

Different frequencies of acupuncture treatment for chronic low back pain

Table 2

135

Baseline values of all outcomes (raw data).

Outcome (mean, 95% CI)

2 times/wk (n = 15)

5 times/wk (n = 15)

Subjective outcomes
Pain Intensity
Visual analogue Scale (010 cm)
Average back pain
Worst back pain
Average leg pain
Worst leg pain

4.30
6.90
1.97
3.32

Functional Disability
Roland Morris Disability Questionnaire (024)

6.40 (4.37, 8.43)

7.80 (5.41, 10.19)

Quality of Life
Measure Yourself Outcome Prole - Wellbeing score

2.20 (1.72, 2.68)

2.86 (2.07, 3.65)

Psychological Impact
Coping Strategies Questionnaire
Distraction
Catastrophizing
Ignoring pain sensations
Distancing from pain
Coping self-Statements
Praying
Locus of Control Questionnaire
Pain control
Pain responsibility
Objective outcomes
Shuttle Walk Test (m)
Lateral Trunk Flexibility
Left side
Right side

4.87
5.27
9.40
2.60
10.53
2.27

(3.06,
(5.80,
(0.72,
(1.55,

(1.89,
(2.48,
(6.46,
(0.41,
(7.64,
(0.35,

5.53)
8.00)
3.22)
5.09)

7.85)
8.05)
12.34)
4.79)
13.43)
4.18)

3.98
6.40
1.35
2.23

7.73
6.67
10.33
3.87
13.93
2.33

(2.87,
(5.17,
(0.26,
(1.08,

5.10)
7.62)
2.44)
3.38)

(4.64, 10.83)
(3.07, 10.26)
(7.21, 13.46)
(1.67, 6.06)
(11.05, 16.82)
(0.25, 4.42)

20.40 (17.36, 23.44)

11.20 (9.67, 12.73)

18.60 (16.01, 21.19)

11.93 (10.25, 13.62)

468.00 (389.32, 546.68)

563.33 (440.10, 686.56)

15.86 (13.56, 18.16)

16.78 (14.45, 19.11)

17.70 (14.95, 20.45)

17.36 (14.64, 20.08)

Overall T-tests (or non-parametric equivalent, the MannWhitney U test) were not statistically signicant.

of treatment sessions received per participant was 9.2 for

the Low Frequency Group, and 9.8 for the High Frequency
Group. Follow-up data were obtained from 14 (93%) and 15
(100%) participants at 2 weeks, 5 weeks and 3 months, and
11 (73%) and 10 (67%) participants at 1 year, for the Low and
High Frequency Group, respectively.
The baseline demographic, clinical characteristics
(Table 1) and outcome measure scores (Table 2) of the
participants were well balanced between groups, except
for the MYMOP-2 prole score in which the High Frequency
Group was signicantly higher than the score in the Low
Frequency Group (P = 0.034), however 70% follow-up data
for this outcome was missing due to an administrative error,
therefore this part of the data were considered unreliable
and not accounted for in the results.
Based on a TCM diagnostic system, kidney deciency was
shown to be the fundamental cause of LBP, which was often
accompanied by other causes, e.g. muscle strain or colddamp. Points used most frequently in this study were BL23,
BL24, BL26, BL40 and Ashi points. Other common points used
on more than 50% of the participants were Jia Ji, BL18,
BL20, BL25, BL27, BL60, BL62, GV3, CV6, CV12, KI3, KI7,
LR3, GB34, SI3, ST36, SP6. On average 410 needles were
inserted per session. 53% of the participants received cupping and 20% received moxibustion in the Low Frequency

Group, and 47% received cupping and 33% received moxibusion in the High Frequency Group.

Outcomes
Complete case analysis
All of the 30 participants complied adequately with the
relevant treatment. The repeated-measures ANCOVA (using
baseline values as covariates) or MannWhitney U test
revealed no signicant differences at 2 weeks, 5 weeks,
3 months, 1 year or discharge between groups (Fig. 2,
Appendix I).
The repeated-measures one-way ANOVA or Kruskal-Wallis
H test revealed statistically signicant improvements at the
follow-up point compared with baseline for all outcomes
within groups, except some subscales of CSQ (distraction,
ignoring pain sensations, distancing from pain and praying),
PLC-pain control and LTF.
In general, clinically important improvements were found
within the rst two weeks in both groups in terms of most of
the outcome measures, i.e. average/worst LBP VAS, RMDQ,
MYMOP-2-Wellbeing, and SWT, after which there were little change over time up to one year (Fig. 2, Table 3,
Appendix I, II). The same trend was shown for Average/Worst

136

J. Yuan et al.
Imputation analysis
Repeated-measures ANOVA and adjusted repeated-measures
ANCOVA ndings were generally consistent with the complete case analysis, by using imputed values to replace
missing values, as described before.
Power analysis for a non-inferiority trial
Given the small differences between the groups at all time
points (and at 2 weeks in particular given that the Low
Frequency group had only received 4 treatments versus 10
treatments in the High Frequency Group), the power for a
non-inferiority trial was calculated, using Proc Power from
SAS 9.1, with the aim of conrming the lack of difference
between these numbers of treatments at this time point. In
Proc Power the hypothesis was set to the clinically chosen
acceptable inferiority level and the alternative at 0 (i.e. we
calculated power under the assumption that there is truly
no difference between treatments).
For example, we assumed that the less frequent treatment would be regarded as acceptable if the difference in
worst VAS scores for pain were 1 cm, but no larger.
The pooled standard deviation of the mean difference
from this study and the group differences for each outcome
which were considered not to be clinically important (1.0 cm
for the average (SD 1.66) and worst (SD 2.57) VAS, 1.0 points
for the RMDQ (SD 3.9), 0.5 points for the MYMOP-2-Wellbeing
(SD = 1.29), and 10m for the SWT (SD = 208)) were used to
calculate the numbers required in an appropriately sized
non-inferiority trial, with a power of 95% to detect inferiority for pain, functional disability, quality of life and walking
pace between groups. As a result, the minimum number of
participant needed in each group would be: average LBP
on VAS (n = 66), worst LBP on VAS (n = 144), RMDQ (n = 330),
MYMOP-wellbeing (n = 145), SWT (n = 1500). In order to conrm that both treatments are more effective than standard
GP care, a third standard care arm would be included in a
main trial.

Figure 2 Mean (2 SEM) values at baseline, 2 weeks, 5 weeks,

3 months and 1 year.

Leg Pain however such change was not clinically important.

The mean change in most of the outcomes over time
for both groups on the CSQ (Distraction, Ignoring pain sensations, Distancing from pain, Coping self-statements, and
Praying) and PLC subscales (Pain control and Pain responsibility), was within one to three units, which was considered
to be small when compared with the mean change on CSQ
or PLC in previous studies.32,34 The only exception is the
CSQ-catastrophising, where little change was found for both
groups within the rst two weeks, however, at one year
follow-up an improvement was achieved (indicating positive expectancy about coping with pain) in the 2 times/week
group, whereas not in the 5 times/week group.
The mean change in outcomes on LTF (both sides) over
time within both groups was generally within 0.51.0 cm,
which was considered to be small when compared with the
mean change on LTF in previous studies in LBP.35

Effect size
The SMD for all outcomes with available data has been shown
to be small between the two groups at all time points, ranging from 0.41 to 0.65 (Table 3, Appendix II).
Adverse effects
Only some minor incidences were reported throughout the
duration of the trial. In the Low Frequency Group, four participants reported minor bleeding, two reported pain, and
one reported tiredness, minor dizziness, twitch of muscle
and stuck needle respectively. In the High Frequency Group,
seven participants reported minor bleeding, three reported
tiredness, and one reported minor dizziness, headache, redness and dry mouth, respectively.

Discussion
Acupuncture treatment dosage is considered to have an
important impact on outcome,8,9,3638 however, few RCTs
have been conducted to compare the effects of different doses especially treatment frequency. The current pilot
study has conrmed the feasibility to conduct a fully powered non-inferior RCT, to compare different frequencies of
acupuncture for LBP.

Results of outcome measures at 2 weeks, 5 weeks, 3 months and 1 year (raw data).

Outcome

2 times/wk (n = 15)
(mean, 95% CI)

Subjective outcomes
Pain VAS (10cm)
Average back pain
2wks
1.46
5wks
1.23
3mths
1.08
1yr
1.35
Worst back pain
2wks
5wks
3mths
1yr

3.05
2.67
2.69
3.20

5 times/wk (n = 15)
(mean, 95% CI)

5 times/wk 2 times/wk
(mean difference, 95% CI)

P Value

Standard Mean Difference

(random), 95%CI

(0.37,
(0.39,
(0.36,
(0.52,

2.56)
2.07)
1.81)
2.18)

1.03
1.67
1.33
1.41

(0.46,
(0.92,
(0.82,
(0.58,

1.60)
2.43)
1.84)
2.24)

0.43
0.44
0.25
0.06

(0.83,
(1.62,
(1.17,
(1.32,

1.70)
0.74)
0.67)
1.20)

0.49
0.45
0.59
0.92

0.25
0.28
0.20
0.04

[0.48,
[1.01,
[0.93,
[0.88,

0.98]
0.45]
0.53]
0.80]

(1.52,
(1.25,
(1.19,
(1.45,

4.57)
4.09)
4.19)
4.94)

1.96
3.18
3.76
2.79

(0.85,
(2.06,
(2.31,
(1.23,

3.07)
4.30)
5.21)
4.34)

1.09
0.51
1.07
0.41

(0.87,
(2.39,
(3.25,
(2.12,

3.05)
1.38)
1.11)
2.94)

0.26
0.59
0.32
0.74

0.41
0.20
0.36
0.14

[0.32,
[0.93,
[1.10,
[0.70,

1.15]
0.53]
0.37]
0.98]

0.57
0.78
1.20
0.32
0.77

(2.41,
(4.34,
(3.32,
(2.17,
(4.49,

3.54)
2.78)
0.91)
2.81)
2.96)

0.70
0.66
0.25
0.79
0.67

0.14
0.16
0.42
0.11
0.18

[0.59,
[0.89,
[1.16,
[0.73,
[1.02,

0.87]
0.57]
0.31]
0.95]
0.66]

Functional Disability
Roland Morris Disability Questionnaire (024)
2wks
3.50 (1.15, 5.85)
5wks
3.29 (0.74, 5.83)
3mths
1.93 (0.85, 3.01)
1yr
2.92 (0.98, 4.85)
1yr
12.33 (10.35, 14.31)

2.93
4.07
3.13
2.60
13.10

(1.28, 4.58)
(1.80, 6.33)
(1.46, 4.81)
(1.54, 3.66)
(10.09, 16.11)

Different frequencies of acupuncture treatment for chronic low back pain

Table 3

Overall ANCOVAs (using baseline values as covariates), or non-parametric equivalent, the MannWhitney U test were not statistically signicant.

137

138
There was a very high compliance rate for daily or twice
weekly attendance. However, as the study was conducted in
the University clinic, and most of the participants were staff
working in the University, the generalisability of the results
might be limited (academic staff may be more accepting of
RCT activity, with easy access to the study, and therefore
this might have improved compliance). A multi-centered
RCT would be preferred for the main study, involving primary care trusts and hospital physiotherapy departments.
And to promote compliance in the main study, multifactoral
adherence-enhancing strategies may be required.39
Some of the outcome measurements used in this pilot
study have been shown to be sensitive, i.e. VAS, RMDQ,
MYMOP-2 Wellbeing, which demonstrated MCIDs within
groups over time. Little change has been demonstrated in
most of the subscales of CSQ and PLC over time, which
might suggest that either acupuncture does not have any
psychological benets for LBP participants, or these measurements were not sensitive enough in such a small sample
to detect any change. With regards to sensitivity, the CSQcatastrophising subscale appeared to be more sensitive than
the other subscales, as some improvements were achieved
over time in both groups up to one year (Appendix II). In
addition, some RCTs using different psychological measurements have shown that acupuncture is superior over usual
care, in terms of reduction in worry about LBP at 12 and 24
months,40 or psychological distress measured by the hospital
anxiety and depression scale.41,42 Therefore further investigation on the psychological impact of acupuncture for LBP
is required. In addition, the outcomes in our study covered
three of ve domain measures for LBP advocated by a panel
of experts (pain, back-specic function and general healthy
status),43 whereas the other two measures (work disability and patient satisfaction) should be considered in a main
study.
In this study, the SMD for all outcomes with available
data was small at all time points, which corresponds with
some of the effect sizes showed in recent systematic reviews
on acupuncture for chronic LBP,5,36 in which the size of
the effects was inuenced by the nature of the between
group comparison. Thus, the most potent effect sizes (moderate to large) in terms of pain and functional disability
were observed in the comparison of acupuncture versus no
treatment, or acupuncture plus conventional therapy versus conventional therapy alone, whereas other groups of
comparisons generally achieved small to moderate effect
sizes. Given the small differences between the groups at all
time points, the power for a non-inferiority trial was calculated, and the minimum number of participant needed in
each group would range from 66 to 1500, depending on the
outcomes chosen.
To our knowledge, only one trial16 has compared frequency of acupuncture (for migraine), in which two groups of
patients were treated with 10 sessions of the same acupuncture modality, once weekly (Group I, n = 30) or twice weekly
(Group II, n = 15). At the end of the treatment, Group I
seemed to show a better result than Group II, with only
one case of hyperalgesia (3.33%) compared with three cases
(20%) in Group II.16,17 Although these ndings are in contrast
to our study, they are unlikely to be robust as the study
numbers are quite small and the ndings are not based on a
statistical analysis.

J. Yuan et al.
As a result of our study design we were also able to
explore whether there was an optimal number of treatment sessions for LBP (4 treatments versus 10 treatments),
and the exploratory ndings would suggest that fewer treatments may be as effective as more treatment. This conicts
with results from a RCT on chronic LBP which has shown
that participants receiving ten sessions of acupuncture seem
to gain a better effect in reducing pain than participants
receiving ve sessions (again the result was not based on a
statistical analysis),44 and a review38 which suggested that
six or more treatments were important to achieve an optimal
reduction of chronic pain. However, in our study clinically
important improvements with regards to average/worst LBP
VAS, RMDQ, MYMOP-Wellbeing and SWT have been achieved
within the rst two weeks, irrespective of receiving four or
ten treatment sessions, and such improvements were maintained until the one year follow-up. Again, our conclusion
was limited by the small sample size, therefore the minimum number of treatment sessions to produce a clinically
important effect should be explored further.
Some of the strengths of this study in terms of internal/external validity were, rstly, it implemented most of
the items listed by the Van Tulder scale,45 therefore has a
high methodological quality score (internal validity) of 9/11
(two points were missing because patients and acupuncturists were not blinded to the allocation). Secondly with
regards to the external validity, individual acupuncture
treatment was used for each participant in this study, which
has been suggested to be more effective than formula treatments for chronic pain.46,47
Despite the limitations in sample size and measurements
discussed before, some other limitations were, rstly, due to
limited time, the recruitment was stopped before achieving
the original target of 40 participants, however, we considered 30 participants appropriate for such a preliminary
pilot study. Secondly, it could be argued that the clinically
important/statistically signicant improvements commonly
achieved in the rst two-weeks highlighted the possibility of
placebo effects or non-treatment related effects (e.g. natural course of LBP, regression to the mean), therefore future
larger trials should consider placebo and no-treatment controls.
In conclusion, this study has demonstrated the feasibility
of a RCT comparing different frequencies of acupuncture for
chronic LBP; the compliance rate was high; VAS, RMDQ and
MYMOP-Wellbeing might be appropriate outcome measures;
and depending on the outcomes chosen, 66330 participants would be required in a fully powered non-inferiority
trial.

Acknowledgements
Thanks are given to the Vice Chancellors Research Scholarship, and the Strategic Priority Grant, Department for
Employment and Learning, Northern Ireland.

Appendix A. Supplementary data

Supplementary data associated with this article can
be found, in the online version, at doi:10.1016/j.ctim.
2008.10.003.

Different frequencies of acupuncture treatment for chronic low back pain

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