Clinical trial NCT03996928: Eccentric Exercise in Epicondylitis
Official title: Eccentric Exercise in Epicondylitis: Direct Application By Physical Therapist Vs Self-Application By Patient
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Tendinopathy
Keywords: Epicondylitis
Tennis elbow
Eccentric exercise
Lead sponsor: Andaluz Health Service
Sponsor class: OTHER_GOV
First posted: 2019-06-25
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single blind randomized controlled trial

INDEPENDENT VARIABLES

Age, Sex, Work activity (referred to a superior member): intense -including, among other kind of activities, keyboards users and housewives-light.

Basal pain according to visual analogue scale (VAS) of 100 mm. Baseline disability according to the DASH questionnaire (Disabilities of the Arm, Shoulder and Hand), which is self-administered.

DEPENDENT VARIABLES

Pain according to the aforementioned scale just after treatment (2 weeks) and at 3 months.

Disability according to the aforementioned questionnaire just after the treatment (2 weeks) and at three months.

Satisfaction with the treatment right after it (2 weeks) and at three months. A Likert scale of five points ( very satisfied, satisfied, neither satisfied nor unsatisfied, very unsatisfied) will be used.

Co-interventions (Systemic and/or topical route drugs, physiotherapy modalities received outside the system, use of orthoses).
Primary purpose: TREATMENT

Brief summary: There is more and more evidence of the importance of the role of kinesitherapy in the management of epicondylitis, specifically (but not exclusively) of eccentric exercise. Since eccentric kinesitherapy, when applied in a systematic way by a physiotherapist, consumes time and human resources in a significant way, and in the case of such a prevalent pathology, it is frequent that strategies of training the patient are addressed so that this is who perform the exercises after learning them. However, it is not proven that the efficacy and safety of this approach is equivalent to treatment applied by a physiotherapist.

A randomized single-blind controlled trial is conducted that compares both treatment approaches for epicondylitis (eccentric exercises applied directly by a physiotherapist for 10 sessions, and eccentric exercises applied by the patient during the same time) in terms of efficacy against pain, functionality and patient satisfaction, all this within the framework of the public health system.

Detailed description: The main objective of this study is:

To compare the efficacy of an eccentric exercise program applied to patients with epicondylosis by a structured manual program in ten sessions and by an illustrated booklet.

The specific objectives of this study are:

Compare the effectiveness of the above-cited approaches in terms of pain Compare the effectiveness of the above-cited approaches in terms of function Compare the effectiveness of the above-cited approaches in terms of satisfaction

Eligibility criteria: Inclusion Criteria:

* Age between 18 and 65 years old
* Epicondylosis of three or more months of evolution.
* Acceptance of the voluntary participation in the study and signature of the informed consent.

Exclusion Criteria:

* Generalized musculoskeletal pain.
* Rheumatological affections involving of the upper limb.
* Cervicobrachialgia.
* Previous trauma in upper limb.
* Neurological or other pathology that may interfere with the function of the upper limb.
* Being out of work or in litigation due to the pathology of the upper limb.

Primary outcomes:
measure: Visual analogue scale of pain
timeFrame: At two weeks
measure: Visual analogue scale of pain
timeFrame: Three months
measure: Quick-Dash
timeFrame: At two weeks
measure: Quick-Dash
timeFrame: Three months
measure: Satisfaction questionnaire
timeFrame: At two weeks
measure: Satisfaction questionnaire
timeFrame: Three months
Secondary outcomes:
Other outcomes:
Locations:
city: Jaén
country: Spain
facility: Antonio Oya Casero
Study officials:
References:
citation: 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 Aug 25;16:223. doi: 10.1186/s12891-015-0665-4.
citation: Abate M, Silbernagel KG, Siljeholm C, Di Iorio A, De Amicis D, Salini V, Werner S, Paganelli R. Pathogenesis of tendinopathies: inflammation or degeneration? Arthritis Res Ther. 2009;11(3):235. doi: 10.1186/ar2723. Epub 2009 Jun 30.
citation: Nagrale AV, Herd CR, Ganvir S, Ramteke G. Cyriax physiotherapy versus phonophoresis with supervised exercise in subjects with lateral epicondylalgia: a randomized clinical trial. J Man Manip Ther. 2009;17(3):171-8. doi: 10.1179/jmt.2009.17.3.171.
citation: Murgia A, Harwin W, Prakoonwit S, Brownlow H. Preliminary observations on the presence of sustained tendon strain and eccentric contractions of the wrist extensors during a common manual task: implications for lateral epicondylitis. Med Eng Phys. 2011 Jul;33(6):793-7. doi: 10.1016/j.medengphy.2011.02.002. Epub 2011 Mar 16.
citation: Gautam VK, Verma S, Batra S, Bhatnagar N, Arora S. Platelet-rich plasma versus corticosteroid injection for recalcitrant lateral epicondylitis: clinical and ultrasonographic evaluation. J Orthop Surg (Hong Kong). 2015 Apr;23(1):1-5. doi: 10.1177/230949901502300101.
citation: Jindal N, Gaury Y, Banshiwal RC, Lamoria R, Bachhal V. Comparison of short term results of single injection of autologous blood and steroid injection in tennis elbow: a prospective study. J Orthop Surg Res. 2013 Apr 27;8:10. doi: 10.1186/1749-799X-8-10.
citation: Johnson GW, Cadwallader K, Scheffel SB, Epperly TD. Treatment of lateral epicondylitis. Am Fam Physician. 2007 Sep 15;76(6):843-8.
citation: Viola L. A critical review of the current conservative therapies for tennis elbow (lateral epicondylitis). Australas Chiropr Osteopathy. 1998 Jul;7(2):53-67.
citation: Bisset LM, Collins NJ, Offord SS. Immediate effects of 2 types of braces on pain and grip strength in people with lateral epicondylalgia: a randomized controlled trial. J Orthop Sports Phys Ther. 2014 Feb;44(2):120-8. doi: 10.2519/jospt.2014.4744. Epub 2014 Jan 9.
citation: Speed C. A systematic review of shockwave therapies in soft tissue conditions: focusing on the evidence. Br J Sports Med. 2014 Nov;48(21):1538-42. doi: 10.1136/bjsports-2012-091961. Epub 2013 Aug 5.
citation: Olaussen M, Holmedal O, Mdala I, Brage S, Lindbaek M. Corticosteroid or placebo injection combined with deep transverse friction massage, Mills manipulation, stretching and eccentric exercise for acute lateral epicondylitis: a randomised, controlled trial. BMC Musculoskelet Disord. 2015 May 20;16:122. doi: 10.1186/s12891-015-0582-6.
citation: Cullinane FL, Boocock MG, Trevelyan FC. Is eccentric exercise an effective treatment for lateral epicondylitis? A systematic review. Clin Rehabil. 2014 Jan;28(1):3-19. doi: 10.1177/0269215513491974. Epub 2013 Jul 23.
citation: Raman J, MacDermid JC, Grewal R. Effectiveness of different methods of resistance exercises in lateral epicondylosis--a systematic review. J Hand Ther. 2012 Jan-Mar;25(1):5-25; quiz 26. doi: 10.1016/j.jht.2011.09.001. Epub 2011 Nov 9.
citation: Peterson M, Butler S, Eriksson M, Svardsudd K. A randomized controlled trial of eccentric vs. concentric graded exercise in chronic tennis elbow (lateral elbow tendinopathy). Clin Rehabil. 2014 Sep;28(9):862-72. doi: 10.1177/0269215514527595. Epub 2014 Mar 14.
citation: Soderberg J, Grooten WJ, Ang BO. Effects of eccentric training on hand strength in subjects with lateral epicondylalgia: a randomized-controlled trial. Scand J Med Sci Sports. 2012 Dec;22(6):797-803. doi: 10.1111/j.1600-0838.2011.01317.x. Epub 2011 Apr 18.
citation: Tyler TF, Thomas GC, Nicholas SJ, McHugh MP. Addition of isolated wrist extensor eccentric exercise to standard treatment for chronic lateral epicondylosis: a prospective randomized trial. J Shoulder Elbow Surg. 2010 Sep;19(6):917-22. doi: 10.1016/j.jse.2010.04.041. Epub 2010 Jun 26.
citation: Burge E, Monnin D, Berchtold A, Allet L. Cost-Effectiveness of Physical Therapy Only and of Usual Care for Various Health Conditions: Systematic Review. Phys Ther. 2016 Jun;96(6):774-86. doi: 10.2522/ptj.20140333. Epub 2015 Dec 17.
citation: Korthals-de Bos IB, Smidt N, van Tulder MW, Rutten-van Molken MP, Ader HJ, van der Windt DA, Assendelft WJ, Bouter LM. Cost effectiveness of interventions for lateral epicondylitis: results from a randomised controlled trial in primary care. Pharmacoeconomics. 2004;22(3):185-95. doi: 10.2165/00019053-200422030-00004.