Kinesiotaping in Lateral Epicondylitis

October 1, 2019 updated by: Marmara University

A Randomized Controlled Trial Comparing the Effects of Kinesiology Taping With Exercise, Sham Taping With Exercise and Exercise Alone for Lateral Epicondylitis

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 Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey, 34899
        • Marmara University School of Medicine Department of Physical Medicine and Rehabilitation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 58 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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: 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
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: 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. .
Other: Sham taping
Sham taping will be performed without using any technique
Other: 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. .

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Rated Tennis Elbow Evaluation (PRTEE)
Time Frame: 0. week (Baseline), 2. week (After Treatment), 6. week (4 weeks After Treatment)
PRTEE is a 15-item questionnaire designed to measure the forearm pain and disability in patients with LE. PRTEE allows patients to rate their levels of elbow pain and disability from 0 to 10. Test consists of 2 subscales: 1) Pain subscale [5 items] (0 = no pain, 10 = worst imaginable) 2) Function subscale [Specific activities - 6 items, Usual activities - 4 items] (0 = no difficulty, 10 = unable to do). A total score can be computed on a scale of 100 (0 = no disability).
0. week (Baseline), 2. week (After Treatment), 6. week (4 weeks After Treatment)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Disabilities of the Arm, Shoulder and Hand Score (QuickDash)
Time Frame: 0. week (Baseline), 2. week (After Treatment), 6. week (4 weeks After Treatment)
The patients will be requested to score from 1 to 5 points any difficulty experienced during different daily activities related to the upper extremity. Test has 1 module of compulsory items and two optional modules: work module (4 items) and sport/performing arts module (4 items). Scores range from 0 to 100, where higher scores indicate more disability.
0. week (Baseline), 2. week (After Treatment), 6. week (4 weeks After Treatment)
Visual Analogue Scale (VAS) at Rest
Time Frame: 0. week (Baseline), Immediate Effect (right after first taping in KT and sham taping groups), 2. week (After Treatment) and 6. week (4 weeks After Treatment)
Pain on lateral epicondyle at rest during the day was evaluated with the visual analog scale (VAS 0-10 cm). Higher score indicates more pain.
0. week (Baseline), Immediate Effect (right after first taping in KT and sham taping groups), 2. week (After Treatment) and 6. week (4 weeks After Treatment)
Visual Analogue Scale (VAS) at Daily Activity
Time Frame: 0. week (Baseline), Immediate Effect (right after first taping in KT and sham taping groups), 2. week (After Treatment) and 6. week (4 weeks After Treatment)
Pain on lateral epicondyle during daily activity was evaluated with the visual analog scale (VAS 0-10 cm). Higher score indicates more pain.
0. week (Baseline), Immediate Effect (right after first taping in KT and sham taping groups), 2. week (After Treatment) and 6. week (4 weeks After Treatment)
Visual Analogue Scale (VAS) at Night
Time Frame: 0. week (Baseline), 2. week (After Treatment), 6. week (4 weeks After Treatment)
Pain on lateral epicondyle at night was evaluated with the visual analog scale (VAS 0-10 cm). Higher score indicates more pain.
0. week (Baseline), 2. week (After Treatment), 6. week (4 weeks After Treatment)
Painless Grip Strength
Time Frame: 0. week (Baseline), Immediate Effect (right after first taping in KT and sham taping groups), 2. week (After Treatment) and 6. week (4 weeks After Treatment)
Grip strength will be measured using a hand held dynamometer (JAMAR, Sammons Preston, Inc., Bolingbrook, IL). Patients will be asked to grip the dynamometer until (s)he feel pain in elbow. Three evaluations will be made with resting periods in between and average scores will be recorded.
0. week (Baseline), Immediate Effect (right after first taping in KT and sham taping groups), 2. week (After Treatment) and 6. week (4 weeks After Treatment)
Grip Strength
Time Frame: 0. week (Baseline), Immediate Effect (right after first taping in KT and sham taping groups), 2. week (After Treatment) and 6. week (4 weeks After Treatment)
Grip strength will be measured using a hand held dynamometer (JAMAR, Sammons Preston, Inc., Bolingbrook, IL). Patients will be asked to grip with maximum strength. Three evaluations will be made with resting periods in between and average scores will be recorded.
0. week (Baseline), Immediate Effect (right after first taping in KT and sham taping groups), 2. week (After Treatment) and 6. week (4 weeks After Treatment)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Marmara University

Investigators

  • Study Director: Gulseren Derya Akyuz, MD,Prof, Marmara University School of Medicine, PM&R Department
  • Principal Investigator: Esra Giray, Marmara University School of Medicine, PM&R Department

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 10, 2017

Primary Completion (Actual)

April 1, 2018

Study Completion (Actual)

April 30, 2018

Study Registration Dates

First Submitted

March 1, 2017

First Submitted That Met QC Criteria

March 3, 2017

First Posted (Actual)

March 8, 2017

Study Record Updates

Last Update Posted (Actual)

October 3, 2019

Last Update Submitted That Met QC Criteria

October 1, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 09.2017.004

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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