Clinical comparative effectiveness of acupuncture versus manual therapy treatment of lateral epicondylitis: feasibility randomized clinical trial

Katrine Bostrøm, Sverre Mæhlum, Milada Cvancarova Småstuen, Kjersti Storheim, Katrine Bostrøm, Sverre Mæhlum, Milada Cvancarova Småstuen, Kjersti Storheim

Abstract

Background: Lateral epicondylitis (LE) is a challenging condition for clinicians, and research has yet not proven the superiority of one specific treatment approach. However, manual therapy (elbow mobilization) in addition to eccentric exercise has been found to be superior to exercise alone. As well, acupuncture is effective in short-term pain relief when compared with sham treatment, but there is little knowledge on the comparative effectiveness of manual therapy and acupuncture treatment of LE in terms of pain relief. The primary objective of this pilot trial was to assess the feasibility (retention and adherence rates) of performing a randomized controlled trial (RCT) to explore the clinical effectiveness of acupuncture and manual therapy treatment of LE.

Methods: This pilot trial took place in an outpatient interdisciplinary institute of sports medicine and rehabilitation in Oslo, Norway. Thirty-six adults with clinically diagnosed LE were randomly allocated into one of three groups: eccentric exercise alone, eccentric exercise plus acupuncture, or eccentric exercise plus manual therapy for a 12-week treatment period. Primary outcomes were patient retention and adherence rates. Secondary outcomes included patient-reported pain (NRS), level of disability (Quick-DASH), and participant's satisfaction with treatment and global perceived effect.

Results: Nine (69%) patients in the acupuncture group completed the 1-year follow-up, compared to eight (67%) in the manual therapy group and five (45%) in exercise alone. Our goal was to demonstrate a retention rate above 80% to avoid serious threats to validity, but the result was lower than expected. The majority of participants (64%) in both treatment groups received only three-treatment sessions; the reasons included non-attendance or recovery from pain. Secondary outcomes support the rationale for conduction of an RCT. There were no adverse advents related to study participation.

Conclusions: Based on differences in pain relief between groups, patient retention, and adherence rates, an RCT seems to be feasible to assess treatment effectiveness more precisely. In a future definitive trial, greater dropout may be reduced by maintaining contact with the participants in the exercise alone group throughout the intervention, and objective assessments might be considered.

Trial registration: ClinicalTrials.gov, NCT02321696.

Keywords: Eccentric exercise; Physical therapy; Tendinopathy.

Conflict of interest statement

Competing interestsThe authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
Recruitment and participant flow
Fig. 2
Fig. 2
The pattern of change in pain intensity from baseline to last follow-up for all groups. Blue line, exercise alone; green line, manual therapy; red line, acupuncture. Data shown as mean pain using NRS (0–10): 0, no pain; 10, worst pain

References

    1. Waersted M, Hanvold TN, Veiersted KB. Computer work and musculoskeletal disorders of the neck and upper extremity: a systematic review. BMC Musculoskeletal Disorders. 2010. 10.1186/1471-2474-11-79.
    1. Waseem M, Nuhmani S, Ram CS, Sachin Y. Lateral epicondylitis: a review of the literature. J Back Musculoskelet Rehabil. 2012;25:131–142. doi: 10.3233/BMR-2012-0328.
    1. Bisset L, Vicenzino B. Physiotherapy management of lateral epicondylalgia. J Physiother. 2015;61:174–181. doi: 10.1016/j.jphys.2015.07.015.
    1. Walker-Bonde K, Palmer KT, Reading I, Coggon D, Cooper C. Occupation and epicondylitis: a population-based study. Rheumatology. 2012;51:305–310. doi: 10.1093/rheumatology/ker228.
    1. Van Rijn R, Huisstede B, Koes B, Burdorf A. Associations between work-related factors and specific disorders at the elbow: a systematic literature review. Rheumatology. 2009;48:528–536. doi: 10.1093/rheumatology/kep013.
    1. Ahmed Z, Siddiqui N, Malik SS, Abdus-Samee M, Tytherleigh-Strong G, Ruston N. Lateral epicondylitis: a review of pathology and management. Bone Joint J. 2013;95(9):1158–1164. doi: 10.1302/0301-620X.95B9.29285.
    1. Coombes BK, Bisset L, Vicenzino B. A new integrated model of lateral epicondylalgia. Br J Sports Med. 2009;43:252–258. doi: 10.1136/bjsm.2008.052738.
    1. Coombes BK, Bisset L, Vicenzino B. Management of lateral elbow tendinopathy: one size does not fit all. J Orthop Sports Phys Ther. 2015;45:938–949. doi: 10.2519/jospt.2015.5841.
    1. Bisset L, Paungmali A, Vicenzino B, Beller B. A systematic review and meta-analysis of clinical trial on physical interventions for lateral epicondylalgia. Br J Sport Med. 2005;39:411–422. doi: 10.1136/bjsm.2004.016170.
    1. Stasinopoulos D. Lateral elbow tendinopathy: evidence of physiotherapy management. World J Orthop. 2016;7(8):463–466. doi: 10.5312/wjo.v7.i8.463.
    1. Cullinane F, Boocock M, Trevelyan F. Is eccentric exercise an effective treatment for lateral epicondylitis? A systematic review. Clin Rehabil. 2014;28:3–19. doi: 10.1177/0269215513491974.
    1. Ortega-Castillo M, Medina-Porqueres I. Effectiveness of the eccentric exercise therapy in adults with symptomatic shoulder impingement or lateral epicondyle tendinopathy: a systematic review. J Sci Med Sport. 2016:438–53.
    1. Molsberger A. Acupuncture in orthopedics. Der Orthopade. 2012;41:100–105. doi: 10.1007/s00132-011-1865-8.
    1. Vickers AJ, Cronin AM, Maschino AC, et al. Acupuncture for chronic pain: individual patient data-analysis. Arch Intern Med. 2012;172:1444–1453. doi: 10.1001/archinternmed.2012.3654.
    1. Goldman N, Chen M, Fujita T, et al. Adenosine A1 receptors mediate local anti-nociceptive effects of acupuncture. Nat Neurosci. 2010;13:883–889. doi: 10.1038/nn.2562.
    1. Gadan M, Yeung WF, Liu H, et al. Acupuncture and moxibution for lateral epicondylitis: a systematic review of randomized controlled trials. BMC Complement Altern Med. 2014. 10.1186/1472-6882-14-136.
    1. Hoogvliet P, Randsdorp M, Dingemanse R, Koes B, Huisstede B. Does effectiveness of exercise therapy and mobilization techniques offer guidance for the treatment of lateral and medial epicondylitis? A Systematic review. Br J Sports Med. 2013;47:1112–1119. doi: 10.1136/bjsports-2012-091990.
    1. Olaussen Morten, Holmedal Oeystein, Lindbaek Morten, Brage Soeren, Solvang Hiroko. Treating lateral epicondylitis with corticosteroid injections or non-electrotherapeutical physiotherapy: a systematic review. BMJ Open. 2013;3(10):e003564. doi: 10.1136/bmjopen-2013-003564.
    1. Jaki T. Multi-arm clinical trials with treatment selection: what can be gained and at what price. Clin Invest (Lond) 2015;5(4):393–399. doi: 10.4155/cli.15.13.
    1. Ruyter K, Førde R, Solbakk JH. Medisinsk og helsefaglig etikk. Oslo: Gyldendal Norsk Forlag; 2011.
    1. Eldridge S, Chan C, Campbell MJ, et al. CONSORT 2010 statement: extension to randomized pilot and feasibility trials. BMJ. 2016. 10.1136/bmj.i5239.
    1. Peterson M, Butler S, Eriksson M, Sværdsudd K. A randomized controlled trial of eccentric vs. concentric graded exercise in chronic tennis elbow (lateral elbow tendinopathy) Clin Rehabil. 2014;28(9):862–872. doi: 10.1177/0269215514527595.
    1. Stasinopoulos D, Stasinopoulos K, Johnsen MI. An exercise programmer for the management of lateral elbow tendinopathy. Br J Sports Med. 2005;39:944–947. doi: 10.1136/bjsm.2005.019836.
    1. Webster-Harrison Philip, White Adrian, Rae Jonny. Acupuncture for Tennis Elbow: An E-Mail Consensus Study to Define a Standardised Treatment in a Gps— Surgery. Acupuncture in Medicine. 2002;20(4):181–185. doi: 10.1136/aim.20.4.181.
    1. Vicenzino B, Cleland JA, Bisset L. Joint Manipulation in the management of lateral epicondylalgia: a clinical commentary. J Man Manip Ther. 2007;15:50–56. doi: 10.1179/106698107791090132.
    1. Ferreira-Valente MA, Pais-Ribeiro JL, Jensen MP. Validity of four pain intensity-rating scales. Pain. 2011;152(10):2399–2404. doi: 10.1016/j.pain.2011.07.005.
    1. Gummesson C, Ward MM, Atroshi I. The shortened disabilities of the arm, shoulder and hand questionnaire (quick DASH): validity and reliability based on responses within the full-length DASH. BMC Musculoskelet Disord. 2006. 10.1186/1471-2474-7-44.
    1. Haldorsen B, Svege I, Roe Y, Bergland A. Reliability and validity of the Norwegian version of the Disabilities of the Arm, Shoulder and Hand questionnaire in patients with shoulder impingement syndrome. BMC Musculoskelet Disord. 2014. 10.1186/1471-2474-15-78.
    1. Kamper SJ, Ostelo R, Knol DL, Maher CG, De Vet H, Hancock MJ. Global Perceived Effect scales provided reliable assessments of health transition in people with musculoskeletal disorders, but ratings are strongly influenced by status. J Clin Epidemiol. 2010;63:760–766. doi: 10.1016/j.jclinepi.2009.09.009.
    1. Johansen GA, Brook GP. Initial scale development; sample size for pilot studies. Educ Psych Mesa. 2010;70:394–400. doi: 10.1177/0013164409355692.
    1. Aalen OO, Frigessi A, Moger TA, Schiel I, Skovlund E, Veierød MB. Statiske metoder i medisin og helsefag. Oslo: Gyldendal Norsk Forlag; 2012.
    1. Prakash A, Risser RC, Mallinckrodt CH. The impact of analytic method on interpretation of outcomes in longitudinal clinical trials. Int J Clin Pract. 2008;62(8):1147–1158. doi: 10.1111/j.1742-1241.2008.01808.x.
    1. Wasam A. Efficacy vs effectiveness and explanatory vs pragmatic: where is the balance in pain medicine research? Pain Med. 2014;15:539–540. doi: 10.1111/pme.12420.
    1. Paungmali A, Vicenzino B, Smith M. Hypoalgesia induced by elbow manipulation in lateral epicondylalgia does not exhibit tolerance. J Pain. 2003;4(8):448–454. doi: 10.1067/S1526-5900(03)00731-4.
    1. Neal B, Longbottom J. Is there a role for acupuncture in the treatment of tendinopathy? Acupuncture Med. 2012;30(4):346–349. doi: 10.1136/acupmed-2012-010208.
    1. Weber C, Thai V, Neuheuser K, Groover K, Christ O. Efficacy of physical therapy for the treatment of lateral epicondylitis: a meta-analysis. BMC Musculoskelet Disord. 2015. 10.1186/s12891-015-0665-4.
    1. Argent Rob, Daly Ailish, Caulfield Brian. Patient Involvement With Home-Based Exercise Programs: Can Connected Health Interventions Influence Adherence? JMIR mHealth and uHealth. 2018;6(3):e47. doi: 10.2196/mhealth.8518.
    1. Salaffi F, Stancati A, Silvestri CA, Ciapetti A, Grassi W. Minimally clinically important changes in chronic musculoskeletal pain intensity measured on a numerical rating scale. Eur J Pain. 2014;8:283–291. doi: 10.1016/j.ejpain.2003.09.004.
    1. Van Tulder M, Malmivaara A, Hayden J, Koes B. Statistical significance versus clinical importance. trials on exercise therapy for chronic low back pain as example. Spine. 2007;32(16):1785–1790. doi: 10.1097/BRS.0b013e3180b9ef49.

Source: PubMed

3
구독하다