ClinicalTrials.gov
ClinicalTrials.gov Menu

Kinesiotaping in Lateral Epicondylitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03074500
Recruitment Status : Recruiting
First Posted : March 8, 2017
Last Update Posted : April 19, 2017
Sponsor:
Information provided by (Responsible Party):
Marmara University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Lateral Epicondylitis Device: Kinesio taping Other: Sham taping Other: Exercise Not Applicable

Detailed Description:

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Masking Description: To ensure group concealment, randomization will be done by using opaque, sealed envelopes which the assessors will be blinded to
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial Comparing the Effects of Kinesiology Taping With Exercise, Sham Taping With Exercise and Exercise Alone for Lateral Epicondylitis
Actual Study Start Date : March 10, 2017
Estimated Primary Completion Date : August 30, 2017
Estimated Study Completion Date : September 30, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Kinesiotaping
Kinesio taping by using space correction and fascia correction techniques every 3 days for 2 weeks in addition to exercises
Device: Kinesio taping
Kinesio tape will be applied by using space correction and fascia correction technique on forearm of the patients for the treatment of lateral epicondylitis

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. .

Sham Comparator: Sham taping
Sham taping without using any techniques every 3 days for 2 weeks in addition to exercises
Other: Sham taping
Sham taping will be performed without using any technique

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. .

Control
Stretching and strengthening exercises of wrist
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. .




Primary Outcome Measures :
  1. Patient rated tennis elbow evaluation (PRTEQ) [ Time Frame: 30 days ]
    The patients will be asked to complete PRTEQ which is a 15-item questionnaire designed to measure the forearm pain and disability in patients with lateral epicondylitis.


Secondary Outcome Measures :
  1. Grip strength [ Time Frame: 30 days ]
    Grip strength will be measured using a hand held dynamometer (JAMAR, Sammons Preston, Inc., Bolingbrook, IL).

  2. Nirschl score [ Time Frame: 30 days ]
    The stage of disease will be evaluated by using Nirschl score

  3. Visual analogue scale (VAS) [ Time Frame: 30 days ]
    Pain at night and palpation on lateral epicondyle were evaluated with the visual analog scale (VAS 0-10 cm)

  4. The Disabilities of the Arm, Shoulder and Hand Score(QuickDash) [ Time Frame: 30 days ]
    The patients will be requested to score from 1 to 5 points any difficulty experienced during 30 different daily activities related to the upper extremity.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03074500


Contacts
Contact: Gülseren Derya Akyüz, MD,Prof +905324957700 gulserena@gmail.com
Contact: Esra Giray, MD +905558134394 girayesra@hotmail.com

Locations
Turkey
Marmara University School of Medicine Department of Physical Medicine and Rehabilitation Recruiting
Istanbul, Turkey, 34899
Contact: Esra Giray, MD    +905558134394    girayesra@hotmail.com   
Contact: Gulseren Derya Akyuz, Prof    02166254657 ext 4657    gulserena@gmail.com   
Principal Investigator: Gulseren Derya Akyuz, Prof         
Principal Investigator: Esra Giray, MD         
Sub-Investigator: Duygu Gizem Karali, MD         
Sponsors and Collaborators
Marmara University
Investigators
Study Director: Gulseren Derya Akyuz, MD,Prof Marmara University School of Medicine, Department of Physical Medicine and Rehabilitation
Principal Investigator: Esra Giray Marmara University School of Medicine, Department of Physical Medicine and Rehabilitation

Publications of Results:
Other Publications:
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.
Kase K. Clinical therapeutic applications of the Kinesio taping methods. 2016.

Responsible Party: Marmara University
ClinicalTrials.gov Identifier: NCT03074500     History of Changes
Other Study ID Numbers: 09.2017.004
First Posted: March 8, 2017    Key Record Dates
Last Update Posted: April 19, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Marmara University:
Kinesio taping
lateral epicondylitis
tennis elbow
treatment

Additional relevant MeSH terms:
Tennis Elbow
Elbow Tendinopathy
Tendinopathy
Muscular Diseases
Musculoskeletal Diseases
Arm Injuries
Wounds and Injuries
Tendon Injuries