Eccentric Exercise in Epicondylitis

Tendinopathy Clinical Trial

Official title:

Eccentric Exercise in Epicondylitis: Direct Application By Physical Therapist Vs Self-Application By Patient

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03996928
• Other study ID #: OYA-EXC-2019-1
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2017
• Est. completion date: December 1, 2019

Study information

• Verified date: June 2019
• Source: Andaluz Health Service
• Contact: ANTONIO OYA
• Phone: +34953266123
• Email: fisyrec[@]fisyrec.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 1, 2019
• Est. primary completion date: November 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Tendinopathy

Intervention

Other:
• Exercise

Locations

Country	Name	City	State
Spain	Antonio Oya Casero	Jaén

Sponsors (1)

Lead Sponsor	Collaborator
Andaluz Health Service

Country where clinical trial is conducted

Spain, 

References & Publications (18)

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. Review. — View 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. — View Citation

Bürge 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. Review. — View 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. Review. — View 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. — View 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. — View Citation

Johnson GW, Cadwallader K, Scheffel SB, Epperly TD. Treatment of lateral epicondylitis. Am Fam Physician. 2007 Sep 15;76(6):843-8. Review. — View Citation

Korthals-de Bos IB, Smidt N, van Tulder MW, Rutten-van Mölken MP, Adèr 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. — View 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. — View 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. — View Citation

Olaussen M, Holmedal Ø, Mdala I, Brage S, Lindbæk 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. — View Citation

Peterson M, Butler S, Eriksson M, Svärdsudd 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. — View 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. Review. — View Citation

Söderberg 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. — View 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. Review. — View 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. — View 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. — View 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. Review. — View Citation

* Note: There are 18 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual analogue scale of pain	The Visual Analogue Scale (VAS) quantifies of pain described by the patient with maximum reproducibility among observers. It consists of a 10-centimeter horizontal line, at the ends of which the extreme expressions of a symptom are marked: no pain on the left wiht a score 0, and the highest possible pain on the right wiht a score 10. The patient is asked to mark the point that indicates the intensity in the line and is measured with a millimeter ruler. The intensity is expressed in centimeters or millimeters.; A value lower than 4 in the VAS means mild or mild-moderate pain, a value between 4 and 6 implies the presence of moderate-severe pain, and a value greater than 6 implies the presence of very intense pain.	At two weeks
Primary	Visual analogue scale of pain	The Visual Analogue Scale (VAS) quantifies of pain described by the patient with maximum reproducibility among observers. It consists of a 10-centimeter horizontal line, at the ends of which the extreme expressions of a symptom are marked: no pain on the left wiht a score 0, and the highest possible pain on the right wiht a score 10. The patient is asked to mark the point that indicates the intensity in the line and is measured with a millimeter ruler. The intensity is expressed in centimeters or millimeters.; A value lower than 4 in the VAS means mild or mild-moderate pain, a value between 4 and 6 implies the presence of moderate-severe pain, and a value greater than 6 implies the presence of very intense pain.	Three months
Primary	Quick-Dash	At least 10 of the 11 questions must be completed to calculate the score Disability / Symptom of Quick DASH.; The assigned values for all the complete answers are summed and averaged, giving as a result, a score based on five. This value is then taken to a score based on 100 subtracting 1 and multiplying it by 25. A higher score greater disability.	At two weeks
Primary	Quick-Dash	At least 10 of the 11 questions must be completed to calculate the score Disability / Symptom of Quick DASH.; The assigned values for all the complete answers are summed and averaged, giving as a result, a score based on five. This value is then taken to a score based on 100 subtracting 1 and multiplying it by 25. A higher score greater disability.	Three months
Primary	Satisfaction questionnaire	A survey will be carried out to find out what the patient has perceived by asking a question about his satisfaction with the treatment received, choosing one of the following answers: Very satisfied; Satisfied; Neither satisfied nor unsatisfied; Unsatisfied; Very unsatisfied	At two weeks
Primary	Satisfaction questionnaire	A survey will be carried out to find out what the patient has perceived by asking a question about his satisfaction with the treatment received, choosing one of the following answers: Very satisfied; Satisfied; Neither satisfied nor unsatisfied; Unsatisfied; Very unsatisfied	Three months