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Hay, Elaine; Barlas, Panos; Foster, Nadine; Hill, Jonathan; Thomas, Elaine; Young, Julie (2004)
Publisher: BioMed Central
Journal: BMC Musculoskeletal Disorders
Languages: English
Types: Article
Subjects: Diseases of the musculoskeletal system, RC925-935, Study Protocol, RA



Acupuncture is a popular non-pharmacological modality for treating musculoskeletal pain. Physiotherapists are one of the largest groups of acupuncture providers within the NHS, and they commonly use it alongside advice and exercise. Conclusive evidence of acupuncture's clinical effectiveness and its superiority over sham interventions is lacking. The Arthritis Research Campaign (arc) has funded this randomised sham-controlled trial which addresses three important questions. Firstly, we will determine the additional benefit of true acupuncture when used by physiotherapists alongside advice and exercise for older people presenting to primary care with knee pain. Secondly, we will evaluate sham acupuncture in the same way. Thirdly, we will investigate the treatment preferences and expectations of both the participants and physiotherapists participating in the study, and explore the effect of these on clinical outcome. We will thus investigate whether acupuncture is a useful adjunct to advice and exercise for treating knee pain and gain insight into whether this effect is due to specific needling properties.


This randomised clinical trial will recruit 350 participants with knee pain to three intervention arms. It is based in 43 community physiotherapy departments in 21 NHS Trusts in the West Midlands and Cheshire regions in England. Patients aged 50 years and over with knee pain will be recruited. Outcome data will be collected by self-complete questionnaires before randomisation, and 6 weeks, 6 months and 12 months after randomisation and by telephone interview 2 weeks after treatment commences. The questionnaires collect demographic details as well as information on knee-related pain, movement and function, pain intensity and affect, main functional problem, illness perceptions, self-efficacy, treatment preference and expectations, general health and quality of life. Participants are randomised to receive a package of advice and exercise; or this package plus real acupuncture; or this package plus sham acupuncture. Treatment details are being collected on a standard proforma. Interventions are delivered by experienced physiotherapists who have all received training in acupuncture to recognised national standards. The primary analysis will investigate the main treatment effects of real or sham acupuncture as an adjunct to advice and exercise.


This paper presents detail on the rationale, design, methods, and operational aspects of the trial.

  • The results below are discovered through our pilot algorithms. Let us know how we are doing!

    • McAlindon TE, Cooper C, Kirwan JR, Dieppe PA: Knee pain and disability in the community. Br J Rheumatol 1992, 31:189-192.
    • 2. O'Reilly SC, Muir KR, Doherty M: Screening for pain in knee osteoarthritis: which question? Ann Rheum Dis 1996, 55:931-933.
    • 3. Scott DL, Shipley M, Dawson A, Edwards S, Symmons DP, Woolf AD: The clinical management of rheumatoid arthritis and osteoarthritis: strategies for improving clinical effectiveness. Br J Rheumatol 1998, 37:546-554.
    • 4. Hawley DJ, Wolfe F: Pain, disability, and pain/disability relationships in seven rheumatic disorders: a study of 1,522 patients. J Rheumatol 1991, 18:1552-1557.
    • 5. Creamer P, Flores R, Hochberg MC: Management of osteoarthritis in older adults. Clin Geriatr Med 1998, 14:435-454.
    • 6. Hochberg MC, Altman RD, Brandt KD, Clark BM, Dieppe PA, Griffin MR, Moskowitz RW, Schnitzer TJ: Guidelines for the medical management of osteoarthritis. Part II. Osteoarthritis of the knee. Arthritis Rheum 1995, 38:1541-1546.
    • 7. Lane NE, Thompson JM: Management of osteoarthritis in the primary-care setting: an evidence-based approach to treatment. Am J Med 1997, 103:25S-30S.
    • 8. Altman RD, Lozada CJ: Practice guidelines in the management of osteoarthritis. Osteoarthritis Cartilage 1998, 6:22-24.
    • 9. The Primary Care Rheumatology Society: The management of osteoarthritis - Guidelines 1999 [http://www.pcrsociety.com/guidelines/ management_osteoarthritis.html].
    • 10. Mazzuca SA, Brandt KD, Katz BP, Dittus RS, Freund DA, Lubitz R, Hawker G, Eckert G: Comparison of general internists, family physicians, and rheumatologists managing patients with symptoms of osteoarthritis of the knee. Arthritis Care Res 1997, 10:289-299.
    • 11. Coyte PC, Hawker G, Croxford R, Attard C, Wright JG: Variation in rheumatologists' and family physicians' perceptions of the indications for and outcomes of knee replacement surgery. J Rheumatol 1996, 23:730-738.
    • 12. Arthritis Care Report: Osteoarthritis Nation: the most comprehensive UK report of people with osteoarthritis 2004 [http://oanation.arthritis care.org.uk].
    • 13. Pencharz JN, Grigoriadis E, Jansz GF, Bombardier C: A critical appraisal of clinical practice guideline for the treatment of lower-limb osteoarthritis. Arthritis Res 2002, 4:36-44.
    • 14. Wainapel SF, Thomas AD, Kahan BS: Use of alternative therapies by rehabilitation outpatients. Arch Phys Med Rehabil 1998, 79:1003-1005.
    • 15. Eisenberg DM, Kessler RC, Foster C, Norlock FE, Calkins DR, Delbanco TL: Unconventional medicine in the United States. Prevalence, costs and patterns of use. N Engl J Med 1993, 328:246-252.
    • 16. Eisenberg DM, Davis RB, Ettner SL, Appel S, Wilkey S, Van Rompay M, Kessler RC: Trends in alternative medicine in the United States: 1990-1997. Results of a follow-up national survey. JAMA 1998, 280:1569-1575.
    • 17. Thomas K, Fall M, Parry G, Nichol J: National survey of access to complementary health care via general practice 1995 [http://www.shef.ac.uk/ scharr/mcru/reports/access1.pdf]. Sheffield: University of Sheffield
    • 18. Filshie J, White AR: Medical acupuncture London: Churchill-Livingstone; 1998.
    • 19. Ernst E, White A: The BBC survey of complementary medicine use in the UK. Complement Ther Med 2000, 8:32-36.
    • 20. Vickers A: Recent advances: Complementary medicine. BMJ 2000, 321:683-686.
    • 21. Woollam CHM, Jackson AO: Acupuncture in the management of chronic pain. Anaesthesia 1998, 53:593-595.
    • 22. Zollman C, Vickers A: ABC of complementary medicine: Users and practitioners of complementary medicine. BMJ 1999, 319:836-838.
    • 23. Felson DT, Lawrence RC, Hochberg MC, McAlindon T, Dieppe PA, Minor MA, Blair SN, Berman BM, Fries JF, Weinberger M, Lorig KR, Jacobs JJ, Goldberg V: Osteoarthritis: new insights. Part 2: Treatment approaches. Ann Intern Med 2000, 133:726-737.
    • 24. Hurley M, Dziedzic K, Bearne L, Sim J, Bury T: Clinical and cost effectiveness of physiotherapy in the management of older people with common rheumatological conditions 2001 [http://www.csp.org.uk/effectiveprac tice/evidencebasedpractice/publications.cfm]. London: Chartered Society of Physiotherapy
    • 25. Puett DW, Griffin MR: Published trials of nonmedicinal and noninvasive therapies for hip and knee osteoarthritis. Ann Intern Med 1994, 121:133-140.
    • 26. Foley A, Halbert J, Hewitt T, Crotty M: Does hydrotherapy improve strength and physical function in patients with osteoarthritis - a randomised controlled trial comparing a gymbased and a hydrotherapy based strengthening programme. Ann Rheum Dis 2003, 62:1162-1167.
    • 27. Van Baar ME, Assendelft WJJ, Dekker J, Oostendorp RAB, Bijlsma JWJ: Effectiveness of exercise therapy in patients with osteoarthritis of the hip or knee. Arthritis Rheum 1999, 42:1361-1369.
    • 28. Evcik D, Sonel B: Effectiveness of a home-based exercise therapy and walking program on osteoarthritis of the knee. Rheumatol Int 2002, 22:103-106.
    • 29. Rejeski WJ, Focht BC, Messier SP, Morgan T, Pahor M, Penninx B: Obese, older adults with knee osteoarthritis: weight loss, exercise and quality of life. Health Psychol 2002, 21:419-426.
    • 30. Thomas KS, Muir KR, Doherty M, Jones AC, O'Reilly SC, Bassey EJ: Home based exercise programme for knee pain and knee osteoarthritis: randomised controlled trial. BMJ 2002, 325:752-756.
    • 31. Topp R, Woolley S, Hornyak J, Khuder S, Kahaleh B: The effect of dynamic versus isometric resistance training on pain and functioning among adults with osteoarthritis of the knee. Arch Phys Med Rehabil 2002, 83:1187-1195.
    • 32. Lewek MD, Rudolph KS, Snyder-Mackler L: Quadriceps femoris muscle weakness and activation failure in patients with symptomatic knee osteoarthritis. J Orthop Res 2004, 22:110-115.
    • 33. Jordan KM, Arden NK, Doherty M, Bannwarth B, Bijlsma JW, Dieppe P, Gunther K, Hauselmann H, Herrero-Beaumont G, Kaklamanis P, Lohmander S, Leeb B, Lequesne M, Mazieres B, Martin-Mola E, Pavelka K, Pendleton A, Punzi L, Serni U, Swoboda B, Verbruggen G, Zimmerman-Gorska I, Dougados M, Standing Committee for International Clinical Studies Including Therapeutic Trials ESCISIT: EULAR Recommendations 2003: an evidence based approach to the management of knee osteoarthritis: Report of a Task Force of the Standing Committee for International Clinical Studies including therapeutic trials (ESCISIT). Ann Rheum Dis 2003, 62:1145-1155.
    • 34. Han JS: Central neurotransmitters and acupuncture analgesia. In: Scientific Bases of Acupuncture Edited by: Pomeranz B, Stux G. New York: Springer-Verlag; 1989:7-33.
    • 35. Andersson S, Lundeberg T: Acupuncture - from empiricism to science: Functional background to acupuncture effects in pain and disease. Med Hypotheses 1995, 45:271-281.
    • 36. Haker E, Egekvist H, Bjerring P: Effect of sensory stimulation (acupuncture) on sympathetic and parasympathetic activities in healthy subjects. J Autonom Nerv Syst 2000, 79:52-59.
    • 37. Knardahl S, Elam M, Olausson B, Wallin BG: Sympathetic nerve activity after acupuncture in humans. Pain 1998, 75:19-25.
    • 38. Ter Riet G, Kleijnen J, Knipschild P: Acupuncture and chronic pain: A criteria-based meta-analysis. J Clin Epidemiol 1990, 43:1191-1199.
    • 39. Smith LA, Oldman AD, McQuay HJ, Morre RA: Teasing apart quality and validity in systematic reviews: an example from acupuncture trials in chronic neck and back pain. Pain 2000, 86:119-132.
    • 40. Ernst E, White AR: A review of problems in clinical acupuncture research. Am J Chin Med 1997, 25:3-11.
    • 41. Takeda W, Wessel J: Acupuncture for the treatment of pain of osteoarthritic knees. Arthritis Care Res 1994, 7:118-122.
    • 42. Christensen BV, Iuhl IU, Vilbek H, Bullow H-H, Dreijer NC, Rasmussen HF: Acupuncture treatment of severe knee osteoarthrosis: a long term study. Acta Anaesthesiol Scand 1992, 36:519-525.
    • 43. Anonymous: NIH Consensus Conference: Acupuncture. JAMA 1998, 280:1518-1524.
    • 44. Deluze C, Bosia L, Zirbs A, Chantraine A, Vischer TL: Electroacupuncture in fibromyalgia: Results of a controlled trial. BMJ 1992, 305:1249-1252.
    • 45. Berman BM, Swyers JP: Complementary medicine treatments for fibromyalgia syndrome. Baillieres Best Pract Res Clin Rheumatol 1999, 13:487-492.
    • 46. Ezzo J, Hadhazy V, Birch S, Lao L, Kaplan G, Hochberg M, Berman B: Acupuncture for osteoarthritis of the knee: a systematic review. Arthritis Rheum 2001, 44:819-825.
    • 47. Streitberger K, Kleinhenz J: Introducing a placebo needle into acupuncture research. Lancet 1998, 352:364-365.
    • 48. White P, Lewith G, Hopwood V, Prescott P: The placebo needle, is it a valid and convincing placebo for use in acupuncture trials? A randomised, single-blind, cross-over pilot trial. Pain 2003, 106:401-409.
    • 49. Brinkhaus B, Becker-Witt C, Jena S, Linde K, Streng A, Wagenpfeil S, Irnich D, Hummelsberger J, Melchart D, Willich SN: Acupuncture Randomized Trials (ART) in patients with chronic low back pain and osteoarthritis of the knee - design and protocols. Forsch Komplementarmed Klass Naturheilkd 2003, 10:185-191.
    • 50. Tukmachi E, Jubb R, Dempsey E, Jones P: The effect of acupuncture on the symptoms of knee osteoarthritis-an open randomised controlled study. Acupunct Med 2004, 22:14-22.
    • 51. Ernst E: The placebo needle, is it a valid and convincing placebo for use in acupuncture trials? A randomised, singleblind, cross-over pilot trial [letter]. Pain 2004, 109:197-8.
    • 52. NHS Executive: R&D in primary care. National Working Group report (the Mant report) 1997 [http://www.rcgp.org.uk/information/publica tions/summaries/summary98/summ9804.doc]. London: Department of Health
    • 53. Rainville J, Bagnall D, Phalen L: Health care providers' attitudes and beliefs about functional impairments and chronic back pain. Clin J Pain 1995, 11:287-295.
    • 54. Moss-Morris R, Weinman J, Petrie K, Horne R, Cameron LD, Buick D: The Revised Illness Perception Questionnaire (IPQ-R). Psychol Health 2002, 17:1-16.
    • 55. Hurley MV: The role of muscle weakness in the pathogenesis of osteoarthritis. Rheum Dis Clin North Am 1999, 25:283-298.
    • 56. Foster NE, Barlas P, Dziedzic K, Daniels J, Gray R: Current physiotherapy management of knee osteoarthritis informs a clinical trial [abstract]. Rheumatology 2000, 39(Supp 1):166.
    • 57. Melchart D, Linde K, Fischer P, Berman B, White A, Vickers A, Allais G: Acupuncture for idiopathic headache (Cochrane Review). In The Cochrane Library 2004): [http://www.cochrane.org/cochrane/ revabstr/ab001218.htm]. Chichester, UK: John Wiley & Sons Ltd
    • 58. He D, Bo Veiersted K, Hostmark AT, Ingulf Medbo J: Effect of acupuncture treatment on chronic neck and shoulder pain in sedentary female workers: a 6-month and 3-year follow-up study. Pain 2004, 109:299-307.
    • 59. Kleinhenz J, Streitberger K, Windeler J, G├╝├čbacher A, Mavridis G, Martin E: Randomised clinical trial comparing the effects of acupuncture and a newly designed placebo needle in rotator cuff tendinitis. Pain 1999, 83:235-241.
    • 60. Vincent CA, Lewith G: Placebo controls for acupuncture studies. J R Soc Med 1995, 88:199-202.
    • 61. Bellamy N: WOMAC Osteoarthritis Index. A User's Guide. London (Ontario): London Health Services Centre, McMaster University; 1996.
    • 62. Lorig K, Chastain RL, Ung E, Shoor S, Holman HR: Development and evaluation of a scale to measure perceived self-efficacy in people with arthritis. Arthritis Rheum 1989, 32:37-44.
    • 63. Kind P, Dolan P, Gudex C, Williams A: Variations in population health status: results from a United Kingdom national questionnaire survey. BMJ 1998, 316:736-741.
    • 64. Office for National Statistics: Standard occupational classification 2000. The coding index. London 2000, 2:.
    • 65. Office for National Statistics: The National Statistics Socio-economic classification user manual. Version 1. London 2002.
    • 66. Peat G, Thomas E, Handy J, Wood L, Dziedzic K, Myers H, Wilkie R, Duncan R, Hay E, Hill J, Croft P: The Knee Clinical Assessment Study - CAS(K): Prospective study of knee pain and knee osteoarthritis in the general population. BMC Musculoskeletal Disorders 2004, 5:4.
    • 67. van der Windt DA, Koes BW, Deville W, Boeke AJ, de Jong BA, Bouter LM: Effectiveness of corticosteroid injections versus physiotherapy for treatment of painful stiff shoulder in primary care: randomised trial. BMJ 1998, 317:1292-1296.
    • 68. Norman GR, Streiner DL: Biostatistics: the bare essentials. St Louis: Mosby; 1994:160.
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    The results below are discovered through our pilot algorithms. Let us know how we are doing!

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