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Longer term clinical and
economic benefits of offering
acupuncture care to patients with
chronic low back pain
KJ Thomas,
1*
H MacPherson,
2,3
J Ratcliffe,
1
L Thorpe,
1
J Brazier,
1
M Campbell,
1
M Fitter,
2
M Roman,
4
S Walters
1
and JP Nicholl
1
1
School of Health and Related Research (ScHARR),
University of Sheffield, UK
2
Foundation for Traditional Chinese Medicine, York, UK
3
School of Health Sciences, University of York, UK
4
York and Selby NHS Primary Care Trust, UK
* Corresponding author
HTA
Health Technology Assessment
NHS R&D HTA Programme
Health Technology Assessment 2005; Vol. 9: No. 32
Executive summary
Benefits of offering acupuncture care to patients with
chronic low back pain
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HTA
Objectives
The primary objective was to test the hypothesis
that a population of patients with persistent
non-specific low back pain, when offered access
to traditional acupuncture care alongside
conventional primary care, gained more
long-term relief from pain than those offered
conventional care only, for equal or less cost.
Secondary objectives were to monitor the safety
and acceptability of acupuncture care to patients,
and to assess the evidence for an ‘acupuncturist
effect’ by testing the heterogeneity of outcomes
for the six acupuncturists participating in
the trial.
Methods
Design
The study was a pragmatic, two parallel group,
randomised controlled trial (n = 241). Patients
in the experimental arm were offered the option
of referral to the acupuncture service comprising
six acupuncturists. The control group received
usual care from their general practitioner
(GP). Eligible patients were randomised in
a ratio of 2:1 to the offer of acupuncture to
allow between-acupuncturist effects to be
tested.
Setting
The study was conducted in three non-NHS
acupuncture clinics, with referrals from 39 GPs
working in 16 practices in York, UK.
Subjects
The subjects were patients aged 18–65 years with
non-specific low back pain of 4–52 weeks’
duration, assessed as suitable for primary care
management by their GP.
Interventions
The trial protocol allowed up to ten individualised
acupuncture treatments per patient. The
acupuncturist determined the content and the
number of treatments according to patient need.
Acupuncture patients received needling using
disposable acupuncture needles, and adjunctive
treatments including massage and advice on diet,
rest and exercise. Usual care commonly entailed a
mixture of physiotherapy, medication and
recommended back exercises. Patients receiving
acupuncture care continued to have access to
usual care for their back pain at the discretion of
their GP.
Main outcome measures
The primary outcome measure was the Short
Form 36 (SF-36) Bodily Pain dimension (range
0–100 points), assessed at baseline, and 3, 12 and
24 months. The study was powered to detect a 10-
point difference between groups at 12 months
post-randomisation. Cost–utility analysis was
conducted at 24 months using the EuroQoL 5
Dimensions (EQ-5D) and a preference-based
single index measure derived from the SF-36 (SF-
6D). Secondary outcomes included the McGill
Present Pain Index (PPI), Oswestry Pain Disability
Index (ODI), all other SF-36 dimensions,
medication use, pain-free months in the past year,
worry about back pain, satisfaction with care
received, and safety and acceptability of
acupuncture care.
Results
The trial successfully recruited 241 patients via
referrals from 39 GPs. Two patients withdrew
immediately, leaving 159 in the ‘acupuncture
offer’ arm and 80 in the ‘usual care’ arm. All 159
patients randomised to the offer of acupuncture
care chose to receive acupuncture treatment, and
received an average of eight acupuncture
treatments within the trial.
Analysis of covariance, adjusting for baseline
score, found an intervention effect of 5.6 points on
the SF-36 Pain dimension [95% confidence
interval (CI) –1.3 to 12.5] in favour of the
acupuncture group at 12 months, and 8 points
(95% CI 0.7 to 15.3) at 24 months. No evidence of
heterogeneity of effect was found for the different
acupuncturists. Patients receiving acupuncture care
did not report any serious or life-threatening
events. Sixteen patients dropped out of
acupuncture treatment, four of whom mentioned
specific minor adverse events, such as pain at
the site of needling.
Executive summary: Benefits of offering acupuncture care to patients with chronic low back pain
Executive summary
No treatment effect was found for any of the
SF-36 dimensions other than Pain, or for
the ODI. Patients receiving acupuncture care
reported a significantly greater reduction in worry
about their back pain at 12 and 24 months
compared with the usual care group. At 24
months, the acupuncture care group was
significantly more likely to report 12 months pain
free and less likely to report the use of medication
for pain relief.
The acupuncture service was found to be cost-
effective at 24 months; the estimated cost per
quality-adjusted (QALY) was £4241 (95% CI £191
to £28,026) using the SF-6D scoring algorithm
based on responses to the SF-36, and £3598 (95%
CI £189 to £22,035) using the EQ-5D health
status instrument. The NHS costs were greater in
the acupuncture care group than in the usual care
group. However, the additional resource use was
less than the costs of the acupuncture treatment
itself, suggesting that some usual care resource use
was offset.
Conclusions
Traditional acupuncture care delivered in a
primary care setting was safe and acceptable to
patients with non-specific low back pain.
Acupuncture care and usual care were both
associated with clinically significant improvement
at 12- and 24-month follow-up. Acupuncture care
was significantly more effective in reducing bodily
pain than usual care at 24-month follow-up. No
benefits relating to function or disability were
identified. GP referral to a service providing
traditional acupuncture care offers a cost-effective
intervention for reducing low back pain over a
2-year period.
Implications for healthcare
Based on the study’s findings, commissioners of
musculoskeletal services would be justified in
considering making GP referral to a short course
of traditional acupuncture care available for a
typical population of primary care attendees with
persistent non-specific low back pain.
Recommendations for research
The following recommendations are suggested for
further research.
●
Trials are needed to assess the impact of
traditional acupuncture on the persistence and
recurrence of low back pain compared with
other possible short-term packages of care (such
as massage, chiropractic or physiotherapy),
delivered in an episode of non-acute low back
pain.
●
The cost-effectiveness of different types of
acupuncture offered as short-term packages of
care, delivered in an episode of non-acute low
back pain, could be assessed.
●
Research is needed into the optimum timing for
an acupuncture treatment package in a patient
episode of low back pain, and to assess the
value of repeated courses of acupuncture for
patients experiencing recurrent episodes of low
back pain.
●
Further studies with more patients per
acupuncturist are warranted to explore
differences between acupuncturists. No
significant difference between acupuncturists
was found in this study. However, this lack of
evidence of heterogeneity does not mean that
there is no heterogeneity.
●
Exploration is needed of the underlying causes
and mechanisms involved in the continued
improvement over time of patients with low
back pain receiving a short course of traditional
acupuncture.
●
Qualitative investigation is needed into the
meaning to patients of the substantial reported
reduction in worry about back pain found
in the acupuncture care group, but not in the
usual care group, its relationship to patient
coping strategies and its implications for the
care and management of this group of
patients.
●
There is a need for the distillation of a protocol
for traditional acupuncture treatment for low
back pain that allows individualised treatment
to be delivered while defining a package of care
that represents value for money, which can be
commissioned reliably and safely.
●
Acupuncture may be delivered in a number of
different ways. This trial examined traditional
acupuncture delivered by qualified
practitioners. There is a case for research to
look at the comparative cost-effectiveness
of different modes of acupuncture offered
as short-term packages of care, delivered in an
episode of non-acute low back pain, for
example acupuncture care delivered by
physiotherapists in a primary care
setting.
●
Qualitative work is indicated to assess the
relative value placed on process utilities by
patients, such as feelings of relaxation and
support during treatment, and the possibility
of trade-off between these and conventional
Health Technology Assessment 2005; Vol. 9: No. 32 (Executive summary)
pain outcomes should be explored using
standard methods for preference elicitation
such as conjoint analysis.
●
Methodological work is needed to guide the
research community about the best way to
proceed with missing data in clinical trials with
longer term outcomes.
Publication
Thomas KJ, MacPherson H, Ratcliffe J, Thorpe L,
Brazier J, Campbell M, et al. Longer term clinical
and economic benefits of offering acupuncture
care to patients with chronic low back pain. Health
Technol Assess 2005;9(32).
Executive summary: Benefits of offering acupuncture care to patients with chronic low back pain
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