Electro-acupuncture for treatment of knee pain from osteoarthritis and the possible endocrinology changes: a study protocol for a randomized controlled trial

Javier Mata, Sandra Cabrera, Pilar Sanchís, Pedro Valentí, Patricia Hernández, Regina Fortuny, Serafin Lirola, Jose Luis Aguilar, Javier Mata, Sandra Cabrera, Pilar Sanchís, Pedro Valentí, Patricia Hernández, Regina Fortuny, Serafin Lirola, Jose Luis Aguilar

Abstract

Background: Osteoarthritis of the knee is a major cause of disability among adults. Electro-acupuncture is considered a potentially useful treatment for osteoarthritis. The purpose of this study is to assess the efficacy of electro-acupuncture on pain control, pain perception, plasma cortisol and beta-endorphin levels, patient-perceived quality of life, and pain medication use in patients with chronic knee pain.

Methods/design: This study is a placebo-controlled, randomized, double-blind, parallel design trial. One hundred sixty out-patients who are more than 50 years old and who have osteoarthritis of the knee will be recruited from the island of Mallorca, Spain. Each participant will be randomly placed into one of two groups: (sham) electro-acupuncture non-insertion technique and real electro-acupuncture. Acupuncture treatments will be the Traditional Chinese Medicine type. The patients will be evaluated after a period of 1 month (with two weekly sessions), 3 months (with one monthly session), 6 months (with one session every 45 days), and 1 year later with follow-up sessions at the end of the study (with one session every 2 months). The primary outcomes will be based on the observed changes from the baseline of the visual analogue scale (VAS) and the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) for pain measured at 12 weeks after the end of treatment. Also to be included in the study are the possible changes in the secondary efficacy variables from baseline as assessed by the Short Form 36 version 2 health survey (patient-perceived quality of life), patient plasma cortisol and beta-endorphin levels at the different treatment stages, the Goldberg Anxiety and Depression Scale, pain medication use, functional capacity and stiffness (WOMAC subscales), and a VAS. These variables will be assessed at 1 month, 3 months, 6 months, and 1 year after study commencement.

Discussion: The findings from this study will help to determine whether electro-acupuncture is effective for chronic knee pain management in older people and whether electro-acupuncture can deliver results for the improvement of pain relief, stiffness, and disability. The study will therefore be a major step toward understanding the roles of the hypothalamic-pituitary-adrenal axis and the endogenous opioid system in the effectiveness of electro-acupuncture for chronic pain.

Trial registration: ClinicalTrials.gov identifier NCT02299713 (11 Nov. 2014).

Figures

Fig. 1
Fig. 1
Trial flow. The study trial flow is described, indicating the patient selection process, treatment, and follow-up. *Visual analogue scale, Western Ontario and McMaster Universities Osteoarthritis Index, Short Form 36 version 2 health survey, blood sample collection, Goldberg Anxiety and Depression Scale, and medication use are measured on each follow-up visit. EA, Electro-acupuncture

References

    1. Lawrence RC, Helmick CG, Arnett FC, Deyo RA, Felson DT, Giannini EH, et al. Estimates of the prevalence of arthritis and selected musculoskeletal disorders in the United States. Arthritis Rheum. 1998;41:778–99. doi: 10.1002/1529-0131(199805)41:5<778::AID-ART4>;2-V.
    1. Felson DT, Lawrence RC, Dieppe PA, Hirsch R, Helmick CG, Jordan JM, et al. Osteoarthritis: new insights. Part 1: the disease and its risk factors. Ann Intern Med. 2000;133:635–46. doi: 10.7326/0003-4819-133-8-200010170-00016.
    1. Bijlsma JW, Berenbaum F, Lafeber FP. Osteoarthritis: an update with relevance for clinical practice. Lancet. 2011;377:2115–26. doi: 10.1016/S0140-6736(11)60243-2.
    1. Zhang Y, Jordan JM. Epidemiology of osteoarthritis. Clin Geriatr Med. 2010;26:355–69. doi: 10.1016/j.cger.2010.03.001.
    1. Ausiello JC, Stafford RS. Trends in medication use for osteoarthritis treatment. J Rheumatol. 2002;29:999–1005.
    1. National Collaborating Centre for Chronic Conditions . Osteoarthritis: national clinical guideline for care and management in adults. London: Royal College of Physicians; 2008.
    1. Zhang FW, Moskowitz RW, Nuki G, Abramson S, Altman RD, Arden N. OARSI recommendations for the management of hip and knee osteoarthritis, Part II: OARSI evidence-based, expert consensus guidelines. Osteoarthritis Cartilage. 2008;16:137–62. doi: 10.1016/j.joca.2007.12.013.
    1. MacPherson H, Thomas K, Walters S, Fitter M. The York acupuncture safety study: prospective survey of 34 000 treatments by traditional acupuncturists. BMJ. 2001;323:486–7. doi: 10.1136/bmj.323.7311.486.
    1. White A, Hayhoe S, Hart A, Ernst E. Adverse events following acupuncture: prospective survey of 32 000 consultations with doctors and physiotherapists. BMJ. 2001;323:485–6. doi: 10.1136/bmj.323.7311.485.
    1. Cherkin DC, Sherman KJ, Deyo RA, Shekelle PG. A review of the evidence for the effectiveness, safety, and cost of acupuncture, massage therapy, and spinal manipulation for back pain. Ann Intern Med. 2003;138:898–906. doi: 10.7326/0003-4819-138-11-200306030-00011.
    1. Lao L, Hamilton GR, Fu J, Berman BM. Is acupuncture safe? A systematic review of case reports. Altern Ther Health Med. 2003;9:72–83.
    1. Melchart D, Weidenhammer W, Streng A, Reitmayr S, Hoppe A, Ernst E, et al. Prospective investigation of adverse effects of acupuncture in 97 733 patients. Arch Intern Med. 2004;164:104–5. doi: 10.1001/archinte.164.1.104.
    1. American College of Rheumatology Subcommittee on Osteoarthritis Guidelines Recommendations for the medical management of osteoarthritis of the hip and knee: 2000 update. Arthritis Rheum. 2000;43:1905–15. doi: 10.1002/1529-0131(200009)43:9<1905::AID-ANR1>;2-P.
    1. Jordan K, Arden N, Doherty M, Bannwarth B, Bijlsma J, Dieppe P, et al. 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;62:1145–55. doi: 10.1136/ard.2003.011742.
    1. Herman JP, Figueiredo H, Mueller NK, Ulrich-Lai Y, Ostrander MM, Choi DC, et al. Central mechanisms of stress integration: hierarchical circuitry controlling hypothalamo-pituitary-adrenocortical responsiveness. Front Neuroendocrinol. 2003;24:151–80. doi: 10.1016/j.yfrne.2003.07.001.
    1. Harris RE, Zubieta JK, Scott DJ, Napadow V, Gracely RH, Clauw DJ. Traditional Chinese acupuncture and placebo (sham) acupuncture are differentiated by their effects on [mu]-opioid receptors (MORs) Neuroimage. 2009;47:1077–85. doi: 10.1016/j.neuroimage.2009.05.083.
    1. Zubieta JK, Stohler CS. Neurobiological mechanisms of placebo responses. Ann N Y Acad Sci. 2009;1156:198–210. doi: 10.1111/j.1749-6632.2009.04424.x.
    1. Jones GT, Harkness EF, Nahit ES, McBeth J, Silman AJ, Macfarlane GJ. Predicting the onset of knee pain: results from a 2-year prospective study of new workers. Ann Rheum Dis. 2007;66:400–6. doi: 10.1136/ard.2006.057570.
    1. Selfe TK, Taylor AG. Acupuncture and osteoarthritis of the knee: a review of randomized, controlled trials. Fam Community Health. 2008;31:247–54. doi: 10.1097/01.FCH.0000324482.78577.0f.
    1. Ahsin S, Saleem S, Bhatti AM, Iles RK, Aslam M. Clinical and endocrinological changes after electro-acupuncture treatment in patients with osteoarthritis of the knee. Pain. 2009;147:60–6. doi: 10.1016/j.pain.2009.08.004.
    1. Fransen M, McConnell S, Bell M. Exercise for osteoarthritis of the hip or knee. Cochrane Database Syst Rev. 2003;3
    1. Berman BM, Lao L, Langenberg P, Lee WL, Gilpin AM, Hochberg MC. Effectiveness of acupuncture as adjunctive therapy in osteoarthritis of the knee: a randomized, controlled trial. Ann Intern Med. 2004;141:901–10. doi: 10.7326/0003-4819-141-12-200412210-00006.
    1. Witt C, Brinkhaus B, Jena S, Linde K, Streng A, Wagenpfeil S, et al. Acupuncture in patients with osteoarthritis of the knee: a randomised trial. Lancet. 2005;366:136–43. doi: 10.1016/S0140-6736(05)66871-7.
    1. Sangdee C, Teekachunhatean S, Sananpanich K, Sugandhavesa N, Chiewchantanakit S, Pojchamarnwiputh S, et al. Electroacupuncture versus diclofenac in symptomatic treatment of osteoarthritis of the knee: a randomized controlled trial. BMC Complement Altern Med. 2002;2:3. doi: 10.1186/1472-6882-2-3.
    1. Vas J, Méndez C, Perea-Milla E, Vega E, Panadero MD, León JM, et al. Acupuncture as a complementary therapy to the pharmacological treatment of osteoarthritis of the knee: randomised controlled trial. BMJ. 2004;329:1216. doi: 10.1136/bmj.38238.601447.3A.
    1. Moerman DE, Jonas WB. Deconstructing the placebo effect and finding the meaning response. Ann Intern Med. 2002;136:471–6. doi: 10.7326/0003-4819-136-6-200203190-00011.
    1. Whitehurst DG, Bryan S, Hay EM, Thomas E, Young J, Foster NE. Cost-effectiveness of acupuncture care as an adjunct to exercise-based physical therapy for osteoarthritis of the knee. Phys Ther. 2011;91:630–41. doi: 10.2522/ptj.20100239.
    1. Schulz KF, Altman DG, Moher D. CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. BMJ. 2010;340:c332. doi: 10.1136/bmj.c332.
    1. MacPherson H, Altman DG, Hammerschlag R, Li Y, Wu T, White A, et al. Revised Standards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA): extending the CONSORT statement. Acupunct Med. 2010;28:83–93. doi: 10.1136/aim.2009.001370.
    1. Shuster JJ. Practical handbook of sample size guidelines clinical trials MAC. Boca Raton, FL: CRC Press; 1992.
    1. EUROHIS: Developing Common Instruments for Health Surveys. A. Nosikov and C. Gudex (Eds.) Amsterdam: IOS Press; 2003
    1. Montón C, Pérez Echeverría MJ, Campos R, García Campayo J, Lobo A. Anxiety scales and Goldberg’s depression: an efficient interview guide for the detection of psychologic distress. Aten Primaria. 1993;12:345–9.
    1. Ware JE, Jr, Sherbourne CD. The MOS 36-item short-form health survey (SF-36) I Conceptual Framework Item Selection Med Care. 1992;30:473–83.
    1. Alonso J, Prieto L, Antó JM. The Spanish version of the SF-36 Health Survey (the SF-36 health questionnaire): an instrument for measuring clinical results. Med Clin (Barc) 1995;104:771–6.
    1. Lao L, Bergman S, Hamilton GR, Langenberg P, Berman B. Evaluation of acupuncture for pain control after oral surgery: a placebo-controlled trial. Arch Otolaryngol Head Neck Surg. 1999;125:567–72. doi: 10.1001/archotol.125.5.567.
    1. Gong X, Pan Z, Shen Y, Wang S. Blinding effect of non-penetrating sham needle in the randomized controlled trials of acupuncture: a systematic review. J Acupunct Tuina Sci. 2014;12:8–11. doi: 10.1007/s11726-014-0738-1.

Source: PubMed

赞助者和合作者

医疗条件

药物干预

3
订阅