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  • The Internet Journal of Orthopedic Surgery
  • Volume 13
  • Number 2

Original Article

Review of randomised controlled trials comparing efficacy of acupuncture Vs no acupuncture for chronic non-specific low back pain.

S Memon, M Chawala, A Khanna

Citation

S Memon, M Chawala, A Khanna. Review of randomised controlled trials comparing efficacy of acupuncture Vs no acupuncture for chronic non-specific low back pain.. The Internet Journal of Orthopedic Surgery. 2008 Volume 13 Number 2.

Abstract


Study Design:
Systemic review of randomised controlled trials comparing efficacy of acupuncture Vs no acupuncture in non-specific chronic low back pain. Objective: Compare research methods and results. Background: There has been multiple trials to prove the efficacy of acupuncture in patients with non-specific chronic low back pain. We conducted review of randomised controlled trials comparing acupuncture Vs usual care with no acupuncture input. Methods: We identified 8 randomised controlled trials relevant to inclusion criteria. 3 were not focused on the topic and were excluded. Excluded articles were more about immediate pain relief after acupuncture, cost-effectiveness trial and was regarding other branch of Traditional Chinese medicine i.e. Acupressure. Results: None of studies managed to prove dramatic improvement in chronic non-specific back pain, however, all 4 trials proved acupuncture is an effective treatment vs. no acupuncture. 2 trials reached to statistically significant levels, 1 proved long term benefit is more than short term effect and 1 trial with high power managed to reach to near statistically significant. Hence, acupuncture is a safe adjunct to conventional pain relief therapy.

 

Introduction

Non-specific low back pain is one of costliest pain for National Health Service in United Kingdom. About 16% of adult population presents to general practise annually with back pain.1 2 Multitude of non-surgical therapies has been suggested in literature including acupuncture but there is no concrete evidence for the efficacy of the procedure to treat long standing non-specific back pain.34

Acupuncture is the famous branch of Traditional Chinese Medicine (TCM). It is being used by an estimated 2% of adult population in UK for various types of pain management.5Therefore, the purpose of this study is to conduct systemic reviews of randomised trials comparing acupuncture Vs conventional analgesics in chronic low back pain.

Sifting through the literature, we have been unable to find unanimous evidence about the efficacy of the treatment. Although, it has been used in other conditions like radicular back pain,6 pregnancy,7 anxiety and sleep disorders secondary to low back pain,9 and spinal manipulations.8 Acupuncture has been practised in many different ways. Few of them described as Verum, Sham, and electrical stimulation of pins, intramuscular and periosteal acupuncture.9

Figure 1
Table 1 Comparison of Methods

Methods

Study Design and Objective

This is a review of randomised trials comparing acupuncture Vs no acupuncture.

Criteria for selecting studies

We sought trials that compared acupuncture to usual back pain care. We didn’t restrict age, sex or types of acupuncture. We didn’t consider trials of cost effectiveness, or comparing acupuncture with other complimentary therapies.

Search Strategies for Relevant Studies

We conducted a thorough search through major databases, i.e. MEDLINE, EMBASE and Allied and Complimentary medicine and managed to retrieve 274 articles. Our search terms were acupuncture, lumbar and lumbosacral region, pain, backache and low back pain. Our limitations were articles in English language and between the years 2003 and 2005. Review of abstracts identified 8 randomised controlled trials. Last Cochrane review was in 2004 on this topic.10 Out of 8, 3 articles were not focused on the topic and were excluded. 11,12,13,14

Figure 2
Table 2 Comparison of treatment interventions

Results

Report funding

Two studies were funded by insurance and one by NHS (government) and one was funded by Arthritis Association (New York Chapter)

Subject Selection

All 4 studies were multi centred trials conducted in United States of America, United Kingdom and Germany. Investigators selected different age groups of adult population from 18 to 75 years of age with history of chronic low back pain more than 4 weeks to 8 years. They excluded patients with spinal tumour, infection, and fracture or with any neurological deficit (table 1) or spinal cord compression or deformity of the spine.

Randomisation

All 4 studies used computer-generated randomisation to allocate patients into treatment groups. Baseline characteristics were well balanced. Haake et al used 1:1:1 but rest of the investigators preferred to 2:1 randomisation to balance the skills of acupuncturists. All of these studies were based on questionnaires and telephone interviews. Thomas et al couldn’t blind their study because of “pragmatic reasons” but rest of three studies were blinded. Haake et al and Meng et al also assessed their blinding in their questionnaires. It is not very clear whether all patients received their allocated sessions or not. In general, 10/337 in Haake’s17, 1/160 in Thomas’18, 27/147 in Brinkhaus’19, 3/28 in Meng’s20 study didn’t get the active acupuncture treatment. Whether they were included in the final intention to treat analysis is not entirely clear except in Haake’s study where unblended patients were considered non-responders.

Intervention

All 4 studies compared acupuncture Vs no acupuncture. Haake et al and Brinkinhaus et al compared 3 groups namely acupuncture, sham (minimal acupuncture) and no acupuncture (conventional therapy). However, Meng et al and Thomas et al didn’t consider sham acupuncture since it is superficial needling at non-acupuncture points.

Measurements of outcomes

All 4 studies measured multiple outcomes using validated tools for back specific disability, pain, general function, and psychological function (Table 1).

Haake used Von Korff Chronic Pain Grade Scale (VKCPGS) Questionnaire where 33% improvement or 3-point improvement considered statistically significant or 12% improvement on back-specific Hanover Functional Ability (HFA) Questionnaire. This study proved 3.4% (CI –3.7-10.3%; P value-0.39) improvement in Verum vs. sham acupuncture. However, Verum vs. conventional therapy shown considerable improvement of 20.2%(CI13.4%-26.7%; P value-0.001) and sham vs. conventional therapy were 16.8%(CI 10.1%-23.4%; P value 0.001).

Meng et al used Roland Disability questionnaire as main outcome measure where 4-point reduction is significant. They managed to get 4.1-point reduction at week 6 Vs 0.7 point with conventional therapy. He also used global transition score.

Figure 3
Table 1 Flow chart of screening, randomisation, Lost follow up and final analysis.

Brinkhaus et al used modified version of pain questionnaire published by German society for study of pain but primary outcome measure was Visual Analogue Scale (VAS). 40 points change considered significant in VAS. They found 28.7 30.2 mm improvement in acupuncture group, 23.631mm in minimal (sham) acupuncture and 6.922 mm in waiting list patients who were on conventional therapy.

Thomas et al used SF-36 (main outcome measure), oswestry disability index (ODI), McGill present pain index, safety and patient satisfaction. At 12 months, they found 30.8 points reduction in acupuncture and 30.4 points in patients on conventional therapy. This interventional effect was statistically more significant at 24 months at 8 points between acupuncture and no acupuncture (>5 points is significant in SF-36) as compared to 5.6 points at 12 months. Therefore, shown strong evidence of small effect at 24 months but week evidence of some effect of acupuncture at 12 months.

Discussion

Critical appraisal

Haake et al study is one of the biggest and vigorous trials carefully conducted on acupuncture in chronic low back pain. They managed to prove considerable difference between acupuncture vs. guideline based conventional therapy. They managed to segregate physiologic effect from psychological effect by comparing Verum with sham acupuncture which further accentuate the credibility of the trial and understanding of the way acupuncture works. Positive points would be high power, low drop out rates and blinding checks. Negative points can be overtly poor results with conventional therapy.

Meng et al study is the smallest of all 4. Few positives are patients being sole assessors of their symptoms; similarly cross over of patients after the completion of the study did prove the symptom improvements after the treatment. It also reduces the confounding of acupuncture and same pain relief as of acupuncture group further confirms the findings of the acupuncture group. Negative points were low power, needle improvement was mixed with electric stimulation, patients with buttock and leg pain (? Spinal/ vascular) weren’t excluded. On the other hand, 3 patients were excluded because they couldn’t fill in the forms properly and finally, high loss of follow up.

Brinkhaus et al again presented with similar results. They managed to prove statistically significant difference between acupuncture and no acupuncture but no difference between two types of acupuncture. Positive points of this study are well-balanced baseline characteristics and again cross over to prove the results further. It was big multicentre trial but was conducted on outcome measure of limited sensitivity and specificity. They later also took sham acupuncture as placebo but later proven to be wrong and ethically patients were informed of kind of acupuncture they will get after being randomised, though this did help in blinding.

Thomas et al study produced few surprising results that acupuncture produces more long-term results than short term. Technically, well organises study with well-predicted drop out rates and compensating power analysis. 2:1 randomisation allowed to accommodate the difference of acupuncturist’s skills but this did tripped the balance towards acupuncture. Few negatives include open (unblended) trial, “individualizing” the patients (extra 5 acupuncture sessions was provided if pain is not better), all “off work” patients were offered acupuncture and statistically low power but then re recruiting of patients to improve the power.

In conclusion, none of these studies could confirm dramatic improvements in chronic low back pain after acupuncture therapy in short or long term despite of big power but few of them managed to reach statistically significant confidence intervals.

References

1. Department of health. The prevalence of back pain in Great Britain in 1998. London: Government Statistical Service, 1999.
2. Clinical Standards Advisory Group on Back pain. Back pain: Epidemiology and costs. London. HSMO,1994.
3. BMJ Publishing Group. Clinical evidence. Low back pain and Sciatica (Chronic). Feb 2003. www.clinicalevidence.com.
4. Mac Auley D.Back pain and physiotherapy; NHS Treatment is of little value. BMJ 2004, 329;694-5.
5. Thomas KJ, Nichol J, Coleman P. Use and expenditure on complementary medicine in England- a population based survey. Complement Ther Med 2001;9:1-11.
6. Hongchun Y. Acupuncture for intervertebral lumbar disc prolapse: Case studies and clinical experience J-chin-Med, June 2005, CODEN-JCMOB.
7. Guerrerio JB, Nakamurea MU, Cordeiro JA, Kulay L.Jr. Acupuncture for low back pain in Pregnancy – a prospective, quasi-randomised controlled study. Acupunt-Med. Jun 2004, Vol 22, No.2, P-60-7.
8. Johnston BC, DA Costa B R., Devereaux P. J, AKL Elie A, BUSSE Jason W. The use of expertise-based randomised controlled trial to assess spinal manipulation and acupuncture for low back pain – a systemic review. Spine 2008 Apr15;33(8): 914-8.
9. Hansson Y, Carlsson c, Olsson E. Intramuscular periosteal acupuncture for anxiety and sleep quality in patients with chronic musculoskeltal pain—an evaluator blind controlled study. Acupunct-Med, Dec 2007, vol.25, no.4, p.148-57.
10. Furlan AD, van Tulder MW, Cherkin DC, Tsukayama H, Lao L, Koes BW, Berman BM. Acupuncture and dry-needling for low back pain. Cochrane review 2004.
11. Brinkhaus B, Whitt C, Jena S, Linde K, Streng A, Irnich D, Hummelsberger J, Hammes M, Pach D, Melchart D, Willich S. Interventions and Physician Charactersitics in a randomised multicenter trial of acupuncture in patients with low back pain. Journal of Alternative and Complementary Medicine. Sept 1, 2006, 12(7),649-657. doi:10.1089/acm.2006.12.649.
12. Inoue M, Kitakoji H, Ishizaki N, Tawa M, Yano T, Katsumi Y, Kawakita K. Relief of low back pain immediately after acupuncture treatment- a randomised controlled trial. Acupunct Med 2006 Sep;24(3):103-8.
13. Ratcliffe J, Thomas K, MacPherson H. A randomised controlled trial of acupuncture care for persistent low back pain : cost effectiveness analysis. BMJ 2006;333:626 (23 September), doi:10.1136/bmj.38932.806134.7C
14. Itoh K, Katsumi, Yasukazu, Hirota S, Kitakoji H. Effects of trigger point acupuncture on chronic low back pain in elderly patients- a sham controlled randomised trial. Acupunt-Med, Mar 2006, Vol 24, no.1, p-5-12.
15. Haake M, Muller H, Brittinger C, Basler H, Schafer H, Maier C, Endres H, Trampisch H, Molsberger A. German Acupuncture Trials for Chronic low back pain. Arch intern Med Vol 167, no.17 Sep 24, 2007.
16. Thomas KJ, MacPherson H, Thorpe L, Brazier J, Fitter M, Campbell MJ, Roman M, Walters SJ, Nicholl J. Randomised controlled trial of a short course of traditional acupuncture compared with usual care for persistent non-specific low back pain. BMJ DOI:10.1136/bmj.38878.907361.7C 15 september 2006.
17. Brinkhaus B, Witt C, Jena S, Linde K, Streng A, Wagenpfeil S, Irnich D, Walther H, Melchart D, Willich S. Acupuncture in patients with chronic low back pain. A randomised controlled trial. Arch intern Med Vl 166, Feb 27, 2006.
18. Meng C, Wang D, Ngeow, Lao L, Peterson M, Paget S. Acupuncture for chronic low back pain in older patients: a randomised controlled trial. Rheumatology 2003;42:1508-1517

Author Information

Sahib Dino Memon, MRCS
University Hospital of North Staffordshire

Madhavi Chawala, MBBS
Musgrove Park Hospital, Taunton and Somerset NHS Foundation Trust

Anil Khanna, MRCS, MS (Orthopaedics)
University Hospital of North Staffordshire

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