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2 School of Health & Social Care Evaluation of the effectiveness of elbow orthotic devices compared to physiotherapeutic interventions for the treatment of patients with lateral epicondylitis (tennis elbow) A systematic Review Claudia Köckritz Module title: Dissertation Module code: RMH4009-N A Dissertation submitted in partial fulfilment of the requirements of the University of Teesside for the Degree of the Master of Science Advanced Clinical Practice of Manipulative Therapy. Supervisor: John Dixon Date of Submission: 3 rd May 2011 Word count: 14999

3 This research programme was conducted in the School of Health & Social Care, University of Teesside. The copyright of this Dissertation belongs to the author under the terms of the United Kingdom Copyright acts as qualified by the University of Teesside Regulations and Polices. Due acknowledgement must always be made of the use of any material contained in, or derived from, this Dissertation.

4 Abstract Lateral epicondylitis is one of the most diagnosed musculoskeletal disorders at the upper extremity with increasing incidences. The aim of this review was to synthesise the best available evidence on the effectiveness of physiotherapeutic interventions compared to orthotic devices for the treatment of lateral epicondylitis, hence to identify the more effective treatment in reducing pain and improving function. Both treatment approaches are commonly used and recommended by the literature for patients suffering from lateral epicondylitis. Published research provides relevance for both treatment options, nevertheless their effectiveness in comparison seems not to be assessed in previous research, and no systematic review was found which assessed and specifically focused on this objective/comparison. Published research provides relevance for both treatment options, nevertheless their effectiveness in comparison seems not to be assessed in previous research, and no systematic review was found which assessed and specifically focused on this objective/comparison. Exhaustive electronic searches were conducted until November 2010 in PEDro, Cochrane, EMBASE, MEDLINE, AMED and Cinahl databases, supplemented with screening of reference lists and searches in journals and websites. Finally, four RCTs and one CCT were included in this review. For assessing methodological quality of trials the PEDro-scale was implemented. Additionally, reporting quality, methodological and overall issues were critically discussed and judged. Data analysis was performed descriptively, no statistical calculations were included. Appraisal of the trials revealed considerable flaws in reporting and methodological quality. Furthermore, heterogeneity among the trials was detected mainly related to interventions and outcomes characteristics and partly to study population. Overall, there is evidence that physiotherapeutic approaches of exercises with or without supplementary physical therapy are more effective in reducing pain and improving function or activities compared to orthotic devices. This conclusion relates to the efficacy at short-term. Further high-quality research is required with improved methodology, reporting quality and conduction.

5 Zusammenfassung Epicondylitis lateralis ist eine der häufigst diagnostizierten muskoloskeletalen Erkrankung der oberen Extremität, mit steigender Inzidenz. Die Zielsetzung dieses Reviews war es die beste verfügbare Evidenz bezüglich der Effektivität physiotherapeutischer Interventionen im Vergleich zu Orthesen für die Behandlung von epicondylitis lateralis zu synthetisieren, und demzufolge die effektivere Behandlung zur Schmerzlinderung und Funktionsverbesserung zu ermitteln. Beide sind häufig angewendete und von der Literatur empfohlene Behandlungsansätze für Patienten, die an epicondylitis lateralis leiden. Relevanz wird anhand veröffentliche Forschung für beide Behandlungsoptionen vermittelt, dennoch scheint deren Effektivität im Vergleich in vorangegangener Forschung noch nicht bewertet/untersucht worden zu sein. Es wurde kein systematischer Review, welcher diesen Ansatz bzw. Vergleich beurteilt und fokussiert, gefunden. Ausgiebige elektronische Suchen wurden bis November 2010 in den Datenbanken PEDro, Cochrane, EMBASE, MEDLINE, AMED und Cinahl durchgeführt und ergänzt durch Screening von Referenzlisten und Suchen in Journalen und Webseiten. Letztendlich wurden 4 RCTs und 1 CCT in diesen Review einbezogen. Zur Bewertung der Studien bezüglich methodologischer Qualität wurde die PEDro- Skala implementiert. Außerdem, wurden die berichtende Qualität, methodologische und allgemeine Aspekte diskutiert und bewertet. Die Datenanalyse wurde deskriptiv ausgeführt und es wurden keine statistischen Berechnungen eingeschlossen. Die Beurteilung der Studien enthüllte beachtliche Schwachstellen bezüglich der berichtenden und methodologischen Qualität. Des Weiteren, wurde eine Heterogenität zwischen den Studien bemerkt hauptsächlich bezogen auf die Interventionen und Charakteristik der Ergebnissmessungen und teilweise bezüglich der Studienpopulation. Allumfassend, gibt es Evidenz, dass physiotherapeutische Ansätze mittels Übungen, mit oder ohne ergänzende physikalische Therapie, effektiver zur Schmerzreduzierung und Funktions- oder Aktivitätsverbesserung sind im Vergleich zu Orthesen. Diese Schlussfolgerung bezieht sich auf die Kurzzeitwirksamkeit. Weitere Forschung von hoher Qualität mit verbesserter Methodologie, berichtenden Qualität und Durchführung ist erforderlich.

6 Acknowledgements I would like to thank my supervisor, John Dixon, for the excellent support and supervision during the last eight months. Your relaxed and reassuring nature helped me through the period of dissertation and made it far easier for me. I have taken great advantage of your professional knowledge and experience as well as of your very helpful comments and suggestions. Thank you very much for all your motivations and patience! Furthermore, I thank the module leader Dr Katherine Sanderson for the good guidance throughout the module and the provided support to occurring queries. It is very important for me to thank my best friend Jana for the tireless assistance, patience and endurance. You have never got tired to encourage me in many respects throughout the last 2 ½ years and helped me to conquer my language limitations. Thank you very much! I would like to give special thanks to Rosita Boose. Your encouragement and understanding at all times and under any circumstances helps me and means a lot to me and made the Master programme far easier for me. Furthermore, I would like to thank Andrea for always being there on our long way, for providing help and support at any time and for being my Peng you know what I mean.

7 Contents Title page Abstract Acknowledgements Contents List of contents List of tables List of figures i ii iii iv v viii ix

8 List of contents content page 1. Introduction Evidence in current situation 2 2. Specific background Lateral epicondylitis Aetiology Clinical presentation and diagnosing Physiotherapeutic treatment and orthotic interventions Area of research Research question and aims Methods Methodology of review Ethical consideration General approach Design of review Criteria for considering trials for review Types of participants Types of intervention and comparison Types of outcome measures Types of studies Search strategy Data sources Search terms, keywords and strings Data collection and analysis Study selection Data extraction Appraising the quality Data analysis Results Process of search and selection 32

9 st stage of the process nd stage of the process Characteristics of included studies Description of participants Description of interventions and comparison interventions Description of outcomes Quality of methodology and risk of biases Summary of results from included studies Exercise interventions versus orthotic devices Mixed physiotherapeutic approaches versus orthotic devices Discussion Consideration of methodolocial quality and risk of biases of the trials Overall synthesis and implication for practice Critical discussion and limitation of available evidence Implication for future research Strength, weakness and limitation of this review Declaration and conflicts of interest Authors conclusion References 83 Appendices Appendix 1: Ethics release/confirmative letter 96 Appendix 2: Review planning process protocol 97 Appendix 3: Search strategy for the trials 125 Appendix 4: 1 st screening form of literature selection 133 Appendix 5: 2 nd screening form of literature selection 134 Appendix 6: Features of excluded trials 135 Appendix 7: Data extraction form for trials 145 Appendix 8: PEDro Scale form 151

10 Appendix 9: Publication details of included trials 154 Appendix: 10: Results of included studies, complete reporting 155 Consent form for Learning Resource Centre 172 Agreement for Authorship 173

11 List of Tables 4.1. Electronic search results of title and abstract Outcome measures of included trials Characteristics of included trials Results of assessment by PEDro rating criteria Results of included studies of exercise interventions versus orthotic devices Results of included studies of mixed physiotherapeutic approaches versus orthotic devices 61

12 List of Figures Figure 3.1: Flow chart: Procedure of the review 16 Figure 4.1: Flow chart: Search of trials and process of selection 34

13 7. References Altan, L. and Kanat, E. (2008) `Conservative treatment of lateral epicondylitis: comparison of two different orthotic devices `, Clinical Rheumatology, 27 (8), pp Baltaci, G., Bayrakci, T.V., Ergun. N. (2002) ` Effectiveness of Cyriax manipulative therapy and elbow band in the treatment of lateral epicondylitis`, European Journal of Sports Traumatology and Related Research Sep;23(3), pp Barrington, J. and Hage, W.D. (2003) ` Lateral epicondylitis (tennis elbow): nonoperative, open, or arthroscopic treatment?`, Current Opinion in Orthopaedics, 14, pp Barthi A., Avasthi S., Solanki K., Kumar S., Swaroop A., Seangar G.K. (2010), `Clinical assessment of functional outcome in lateral epicondylitis managed by local infiltration of autologous blood`, Internet Medical Journal of Update 2010 January, 5(1) pp.20-24,[online accessed] Beard, J.M. and Safranek, S.M. (2009) `What treatment works best for tennis elbow?`, The Journal Of Family Practice, VOL 58, NO 3, pp Bettany-Saltikov, J. (2010a) `Learning how to undertake a systematic review: part 1`, Nursing Standard, 24 (50), pp Bettany-Saltikov, J. (2010b) `Learning how to undertake a systematic review: part 2`, Nursing Standard, 24 (51), pp Binder, A., Hodge, G., Greenwood, A.M., Hazleman, B.L., Page, Thomas D.P. (1985)` Is therapeutic ultrasound effective in treating soft tissue lesions?` British Medical Journal, Feb 16;290(6467), pp Bisset, L., Paungmali, A., Vicenzino B., Beller, E. (2005) `A systematic review and meta-analysis of clinical trials on physical interventions for lateral epicondylalgia`, British Journal of Sports Medicine ;39, pp Bisset, L., Beller, E., Jull, G., Brooks, P., Darnell, R., Vicenzino, B. (2006) ` Mobilisation with movement and exercise, corticosteroid injection, or wait and see for tennis elbow: randomised trial`, British Medical Journal, Nov 4;333(7575), pp

14 BMJ `Clinical Evidence`, evidence.bmj.com/ceweb/about/index.jsp [online accessed October 2010] Borkholder, C.D., Hill, V.A., Ewing Fees, E. (2004) `The Efficacy of Splinting for Lateral Epicondylitis- A Systematic Review`, Journal of Hand Therapy, 17, pp Bowers D. (2008), Medical Statistics from Scratch- An Introduction for Health Professionals, John Wiley & Sons Ltd., Chichester, England BpB Bundeszentrale für politische Bildung (2006), Buckup, K. (2005), Klinische Tests an Knochen, Gelenken und Muskeln,3rd ed., Stuttgart- New York: Georg-Thieme Verlag Burton, A.K. (1988) ` A comparative trial of forearm strap and topical antiinflammatory as adjuncts to manipulative therapy in tennis elbow`, Manual Medicine;3(4), pp Chen, S.C. (1977) `A Tennis Elbow Support`, British Medical Journal, October 1, p. 894 Chumbley, E.M., O Connor, F.G., Nirschl, R.P. (2000) `Evaluation Of Overuse Elbow Injuries`, American Family Physician, Feb., 61, pp Clinton, R.E. & Murthi, A.M. (2008) `Lateral Epicondylitis`, Current Orthopaedic Practice, Nov./Dec. Vol. 19 (6), pp Collins, J.A. and Fauser, B.C.J.M. (2005) `Balancing the strengths of systematic and narrative reviews`, European Society of Human Reproduction and Embryology Human - Reproduction Update, Vol.11, No.2, pp Coombes, B.K., Bisset, L., Vicenzino, B. (2008) ` A new integrative model of lateral epicondylalgia`, British Journal Of Sports Medicine, 43, pp Crumbley, E.T., Wiebe, N., Cramer, K., Klassen, T.P., Hartling, L. (2005) `Which resources should be used to identify RCT/CCTs for systematic reviews: a systematic review`, BMC Medical Research Methodology, 5, 24,

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18 Johnson, G.W, Cadwallader, K., Scheffel, S.B., Epperly, T.D. (2007) `Treatment of lateral epicondylitis.` American Familiy Physician, Sept. 15, 76(6): (31 ref), [online accessed] Karnath, B. (2003), `Common Musculoskeletal Problems of the upper Extremity: Review of Clinical Signs`, Hospital Physician, January 2003, Knebel, P.T. Avery, D.W., Gebhardt, T.L., Koppenhaver, S.L., Allison, S.C., Bryan, J.M., Kelly, A. (1999) `Effects of the forearm support band on wrist extensor muscle fatigue`, Journal of Orthopaedic and Sports Physical Therapy, Nov 1, 29(11), pp Kochar, M.& Dogra, A. (2002): Effectiveness of a specific physiotherapy regimen on patients with tennis elbow: clinical study, Physiotherapy, 2002 Jun; 88 (6), pp , [online accessed] Kohia M., Brackle J., Byrd K., Jennings A., Murray W., Wilfong E. (2008), `Effectiveness of physical therapy treatments on lateral epicondylitis`, Journal of Sport Rehabilitation, 17(2), pp , [online accessed] Kromer, T.O. (2004), Das Ellenbogengelenk- Grundlagen, Diagnostik, physiotherapeutische behandlung, 2004, XII, Springer-Verlag Liberati A., Altmann, D.G., Tetzlaff, J., Mulrow, C., Gotsche, P.C., Ioannidis, J.P.A., Clarke, M., Devereaux, P.J., Kleijnen, J., Moher, D. (2009) `The PRISMA statement for reporting systematic reviews and meta-analysis of studies that evaluate health care interventions: Explanation and Elaboration`, PLos Medicine, Vol. 6(7): e Locke L.F., Spirduso W.W., Silverman S.J. (2007), `Proposals that work. A Guide for Planning Dissertations and Grant Proposals`, 5 th ed., London Sage Luginbuhl, R., Brunner, F., Schneeberger, A.G. (2008) ` No effect of forearm band and extensor strengthening exercises for the treatment of tennis elbow: a prospective randomised study`, La Chirurgia Degli Organi di Movimento [Musculoskeletal Surgery] Jan;91(1), pp MacDermid, J.C. (2001) `Outcome Evaluation in Patients with Elbow Pathology: Issues in Instrument Development and Evaluation`, Journal of Hand Therapy, April- June, 14, pp

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21 Pienimaki, T., Karinen, P., Kemila, T., Koivukangas, P., Vanharanta, H. (1998) ` Long-term follow-up of conservatively treated chronic tennis elbow patients. A prospective and retrospective analysis`, Scandinavian Journal of Rehabilitation Medicine, Sep;30(3), pp Popey, J. (2006) `Moving beyond effectiveness in evidence synthesis- Methodological issues in the synthesis of diverse sources of evidence`, National Institute for Health and Clinical Excellence [online], Radpasand, M. and Owens, E. (2009) ` Combined multimodal therapies for chronic tennis elbow: pilot study to test protocols for a randomized clinical trial`, Journal of Manipulative and Physiological Therapeutics, Sep;32(7),pp Rompe, J.D., Overend, T.J., MacDermid, J.C. (2007), `Validation of the Patient-rated Tennis Elbow Evaluation Questionnaire`, Journal of Hand Therapy; 2007, 20; pp.3-11, [online accessed] Rosenberg, W. & Donald, A. (1995) `Education and debate - Evidence based medicine: an approach to clinical problem solving`, British Medical Journal, April, 310, pp Sackett, D.L. & Wennberg, J.E. (1997) `Choosing the best research design for each question.` British Medical Journal, 315, Editorial,1636 Scher, D.L., Moriatis, Wolf J., Owens, B.D. (2009), `Lateral Epicondylitis- Review Article`, Orthopaedics,April 2009, Vol. 32, Number 4, pp , [online accessed Scherfer, E. (2006), Forschung verstehen, München: Richard Pflaum Sherrington, C., Herbert, R.D., Maher, C.G., Moseley, A.M. (2000) `PEDro. A database of randomized trials and systematic reviews in physiotherapy`, Manual Therapy, Nov., Vol. 5 (4), pp `Service of U.S. National Institutes of Health` Sevier, T.L. & Wilson, J.K. (1999) ` Utilized in treating lateral epicondylitis`, Physical Therapy Reviews, Jun 1,; 5(2), pp

22 Shiri R., Viikari- Juntura E., Varonen H., Heliövaara M. (2006), `Prevalence and Determinants of Lateral and Medial Epicondylitis: A Population Study`, American Journal of Epidemiology, Vol.164, No.11, pp , [online accessed] Slavin, R.E. (1995) `Best Evidence Synthesis: an intelligent alternative to Metaanalysis`, Journal of Clinical Epidemiology, 48 (1), pp Smidt, N., Assendelft, W.J., Arola, H., Malmivaara, A., Green, S., Buchbinder, R., van der Windt, D., Bouter, L. M. (2003) `Effectiveness of physiotherapy for lateral epicondylitis: a systematic review.`, Annals of Medicine, 35(1), pp Sölveborn, S.A. (1997) ` Radial epicondylalgia ('tennis elbow'): treatment with stretching or forearm band. A prospective study with long-term follow-up including range-of-motion measurements.`, Scandinavian Journal Of Medicine & Science In Sports [Scand J Med Sci Sports] Aug; Vol. 7 (4), pp Statistisches Bundesamt (2008) `Statistisches Jahrbuch 2008`, Struijs, P.A.A., Smidt, N., Arola, H., Van Dijk, C.N., Buchbinder, R., Assendelft, W.J.J. (2001) ` Orthotic devices for tennis elbow: A systematic review` British Journal of General Practice, 51 (472), pp Struijs, P.A., Kerkhoffs, G.M., Assendelft, W.J., van Dijk, C.N. (2004) ` Conservative treatment of lateral epicondylitis: brace versus physical therapy or a combination of both -- a randomized clinical trial`, The American Journal of Sports Medicine, Mar;32(2), pp Struijs, P.A.A., Assendelft, W.J.J., Kerkhoffs, G.M., Souer, S., van Dijk, N. (2005) `The Predictive Value of the Extensor Grip Test for the Effectiveness of bracing for Tennis Elbow`, The American Journal of Sports Medicine, 33, No.12, pp Struijs, P.A.A., Korthals-de Bos, I.B.C., van Tulder, M.W., van Dijk, C.N., Bouter, L.M., Assendelft, W.J.J. (2006) `Cost effectiveness of brace, physiotherapy, or both for treatment of tennis elbow`, British Journal of Sports Medicine, May, 40, pp

23 Svernlov, B. and Adolfsson, L. (2001) ` Non-operative treatment regime including eccentric training for lateral humeral epicondylalgia`, Scandinavian Journal of Medicine & Science in Sports;11(6), pp Theis, C., Herber, S., Meurer, A., Lehr, H.-A., Rompe, J.-D. (2004) `Evidenzbasierte Überprüfung der Therapieempfehlung bei Epicondylopathia humeri lateralis (Tennisellenbogen)- eine Übersicht` Zentralbl Chir 2004; 129(4), pp , Georg Thieme Verlag Stuttgart New York Tonks, J.H., Pai, S.K., Murali, S.R. (2007) `Steroid injection therapy is the best conservative treatment for lateral epicondylitis: a prospective randomised controlled trial`, International Journal of Clinical Practice, Feb;61(2), pp Torgerson D.J. & Torgerson C.J. (2008), Designing Randomised Trials in Health, Education and Social Sciences- An Introduction, Palgrave Macmillan-Great Britain Trudel D.,Duley J., Zastrow I., Kerr E.W., Davidson R., Macdermid J.C. (2004), `Rehabilitation for patients with lateral epicondylitis: a systematic review`, Journal of Hand Therapy, 2004 Apr-Jun, 17(2), [online accessed] Valle-Jones, J.C., Hopkin-Richards, H. (1990) `Controlled trial of an elbow support ( Epitrain ) in patients with acute painful conditions of the elbow: a pilot study.` Curr Med Res Opin, 12, pp Van den Berg, F. (2003) Angewandte Physiologie- 1 Das Bindegewebe des Bewegungsapparates verstehen und beeinflussen`, Georg Thieme Verlag: Stuttgart- New York Vicenzino, B. (2003) ` Lateral epicondylalgia: a musculoskeletal physiotherapy perspective`, Manual Therapy, May 1, 8(2), pp Vicenzino, B., Brooksbank, J., Minto, J., Offord, S., Paungmali, A. (2003) ` Initial effects of elbow taping on pain-free grip strength and pressure pain threshold`, The Journal of Orthopaedic and Sports Physical Therapy, Jul;33(7), pp Viola, L. (1998) `A Critical Review of the Current Conservative Therapies for Tennis Elbow (Lateral Epicondylitis)`, ACO, July, 7 (2), pp

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