Kinesiotaping in Lateral Epicondylitis

NCT ID: NCT03074500

Last Updated: 2019-10-03

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-10

Study Completion Date

2018-04-30

Brief Summary

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The aim of this study is to compare the effects of kinesiology taping with exercise, sham taping with exercise and exercise alone for lateral epicondylitis.

Detailed Description

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Lateral epicondylitis or tennis elbow is a often-encountered disorder of elbow which is characterized by tenderness and pain over lateral epicondylitis of humerus and grip weakness. The annual incidence of lateral epicondylitis has been reported to be %1-3 in general population. Lateral epicondylitis is commonly associated with repetitive overuse of wrist, activities including strong grip which in turn cause microtears and degenerative changes over the common origin of wrist and finger extensors on lateral epicondyle. New researches have shown that the underlying mechanism is degenerative rather than inflammatory. It has been proposed that the cause of pain may be mechanical discontinuity of collagen fibers or biochemical irritation that results from damaged tendon tissue that activates nociceptors. It has been suggested that eccentric loading has been shown to assist with tendon rehabilitation by improving collagen alignment and stimulating collagen cross-linkage formation, both of which can improve tensile strength.

Kinesio taping (KT) which is a new application of adhesive taping was designed by Kenzo Kase to avoid unwanted effects of conventional taping such as restricting range of motion (ROM) and limiting functional activities. The recommended tape application methods are outlined in 'Clinical Therapeutic Applications of the Kinesio Taping Method' 8. Elastic therapeutic tape has been designed to allow for a longitudinal stretch of up to 140% of its resting length and has been designed to approximate the elastic qualities of the human skin. In particular, the application of the tape over stretched muscle to create convolutions in the skin has been hypothesized to reduce pressure in the mechanoreceptors below the dermis, thereby decreasing nociceptive stimuli. Another mechanism which is claimed by the proponent of the tape is that convolutions are raised ridges of the tape and the skin that are thought to decompress underlying structures and allow for enhanced circulation by increased subcutaneous space. In the last few years, the use of KT has become increasingly popular in rehabilitation programs as an adjunct in the treatment. However, scientific evidence about its effect is insufficient.

The aim of this study is to compare the effects of kinesiology taping with exercise, sham taping with exercise and exercise alone for lateral epicondylitis.

Conditions

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Lateral Epicondylitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Parallel Assignment
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors
To ensure group concealment, randomization will be done by using opaque, sealed envelopes which the assessors will be blinded to

Study Groups

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Kinesiotaping

Kinesio taping by using space correction and fascia correction techniques every 3 days for 2 weeks in addition to exercises

Group Type EXPERIMENTAL

Kinesiotaping

Intervention Type DEVICE

Kinesio tape will be applied by using space correction and fascia correction technique on forearm of the patients for the treatment of lateral epicondylitis

Exercise

Intervention Type OTHER

Stretching exercises of wrist 30 seconds to one minute, twice a day and strengthening exercises will performed be 10 repetitions in 2 or 3 series. .

Sham taping

Sham taping without using any techniques every 3 days for 2 weeks in addition to exercises

Group Type SHAM_COMPARATOR

Sham taping

Intervention Type OTHER

Sham taping will be performed without using any technique

Exercise

Intervention Type OTHER

Stretching exercises of wrist 30 seconds to one minute, twice a day and strengthening exercises will performed be 10 repetitions in 2 or 3 series. .

Control

Stretching and strengthening exercises of wrist

Group Type OTHER

Exercise

Intervention Type OTHER

Stretching exercises of wrist 30 seconds to one minute, twice a day and strengthening exercises will performed be 10 repetitions in 2 or 3 series. .

Interventions

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Kinesiotaping

Kinesio tape will be applied by using space correction and fascia correction technique on forearm of the patients for the treatment of lateral epicondylitis

Intervention Type DEVICE

Sham taping

Sham taping will be performed without using any technique

Intervention Type OTHER

Exercise

Stretching exercises of wrist 30 seconds to one minute, twice a day and strengthening exercises will performed be 10 repetitions in 2 or 3 series. .

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Having had symptoms less than 12 weeks
2. Tenderness and pain over lateral epicondylitis
3. Provocation of the lateral elbow pain with at least one of the following tests - resisted middle finger extension (Maudley's test), resisted wrist extension or passive stretch of wrist extensors (Mill's test).

Exclusion Criteria

1. Cervical spondylosis or radiculopathy
2. Diabetes mellitus
3. Neuropathy
4. Arthritis in the upper extremities
5. History of injection and physical therapy for lateral epicondylitis within the last three months
6. Pregnancy
7. History of surgery or acute trauma in the elbow
8. Allergy to tape
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Marmara University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gulseren Derya Akyuz, MD,Prof

Role: STUDY_DIRECTOR

Marmara University School of Medicine, PM&R Department

Esra Giray

Role: PRINCIPAL_INVESTIGATOR

Marmara University School of Medicine, PM&R Department

Locations

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Marmara University School of Medicine Department of Physical Medicine and Rehabilitation

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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Wegener RL, Brown T, O'Brien L. A randomized controlled trial of comparative effectiveness of elastic therapeutic tape, sham tape or eccentric exercises alone for lateral elbow tendinosis. Hand Therapy 2016;21(4):131-9.

Reference Type BACKGROUND

Kase K. Clinical therapeutic applications of the Kinesio taping methods. 2016.

Reference Type BACKGROUND

Lee SS, Kang S, Park NK, Lee CW, Song HS, Sohn MK, Cho KH, Kim JH. Effectiveness of initial extracorporeal shock wave therapy on the newly diagnosed lateral or medial epicondylitis. Ann Rehabil Med. 2012 Oct;36(5):681-7. doi: 10.5535/arm.2012.36.5.681. Epub 2012 Oct 31.

Reference Type RESULT
PMID: 23185733 (View on PubMed)

Kucuksen S, Yilmaz H, Salli A, Ugurlu H. Muscle energy technique versus corticosteroid injection for management of chronic lateral epicondylitis: randomized controlled trial with 1-year follow-up. Arch Phys Med Rehabil. 2013 Nov;94(11):2068-74. doi: 10.1016/j.apmr.2013.05.022. Epub 2013 Jun 22.

Reference Type RESULT
PMID: 23796685 (View on PubMed)

Struijs PA, Smidt N, Arola H, Dijk vC, Buchbinder R, Assendelft WJ. Orthotic devices for the treatment of tennis elbow. Cochrane Database Syst Rev. 2002;(1):CD001821. doi: 10.1002/14651858.CD001821.

Reference Type RESULT
PMID: 11869609 (View on PubMed)

Guo YH, Kuan TS, Chen KL, Lien WC, Hsieh PC, Hsieh IC, Chiu SH, Lin YC. Comparison Between Steroid and 2 Different Sites of Botulinum Toxin Injection in the Treatment of Lateral Epicondylalgia: A Randomized, Double-Blind, Active Drug-Controlled Pilot Study. Arch Phys Med Rehabil. 2017 Jan;98(1):36-42. doi: 10.1016/j.apmr.2016.08.475. Epub 2016 Sep 22.

Reference Type RESULT
PMID: 27666156 (View on PubMed)

Altan L, Kanat E. Conservative treatment of lateral epicondylitis: comparison of two different orthotic devices. Clin Rheumatol. 2008 Aug;27(8):1015-9. doi: 10.1007/s10067-008-0862-8. Epub 2008 Mar 26.

Reference Type RESULT
PMID: 18365136 (View on PubMed)

Dilek B, Batmaz I, Sariyildiz MA, Sahin E, Ilter L, Gulbahar S, Cevik R, Nas K. Kinesio taping in patients with lateral epicondylitis. J Back Musculoskelet Rehabil. 2016 Nov 21;29(4):853-858. doi: 10.3233/BMR-160701.

Reference Type RESULT
PMID: 27232082 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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09.2017.004

Identifier Type: -

Identifier Source: org_study_id

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