- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04518527
Efficiency of Kinesio Taping in Chronic Lateral Epicondylitis
August 14, 2020 updated by: Elif Balevi Batur
Evaluation of Short-term and Residual Effects of Kinesio Taping in Chronic Lateral Epicondylitis: A Randomized, Double-blinded, Controlled Trial
Lateral epicondylitis is a degenerative tendinosis of the extensor carpi radialis brevis muscle and is the most common work/sports-related chronic musculoskeletal problem affecting the elbow.
This randomized, double-blinded, controlled study aimed to evaluate the short term and residual effectiveness of the Kinesio taping method on pain, grip force, quality of life, and functionality.
Study Overview
Detailed Description
Fifty patients diagnosed with chronic unilateral lateral epicondylitis with a symptom duration of at least 12 weeks.
The study group received a true inhibitor Kinesio taping while the control group received sham taping for the first four weeks.
In both groups, progressive stretching and strengthening exercises were given as a home program for 6 weeks.
Patients were assessed with the numerical rating scale (NRS), Cyriax resistive muscle test evaluation, maximal grip strength, PRTEE (Patient- Rated Tennis Elbow Evaluation), and SF-36 (Short Form-36) by the first assessor who was blinded to taping types.
Study Type
Interventional
Enrollment (Actual)
50
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
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Ankara, Turkey
- Gazi University
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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
30 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Having pain on or near the lateral epicondyle and increases with pain at least one of the following provocations tests for lateral epicondylitis -resisted wrist extension (Cozen's test), resisted elbow supination (Mill's test) and 3rd finger extension (Maudley's test),
- Unilateral elbow pain at least 12 weeks,
- Not received injection therapy to the elbow in the last six weeks,
- Not received a physical therapy program in the last three months,
- Presence of normal elbow radiographic findings,
- Normal elbow joint range of motion,
- Having no neurological deficits
Exclusion Criteria:
- Patients with degenerative joint disease,
- Radial tunnel syndrome,
- Cervical nerve root compression,
- Pain reflected from the neck, shoulders,
- Wrist, radiohumeral joint osteochondritis dissecans,
- Tendon rupture,
- Osteoporosis, Infection,
- Malignancy,
- Inflammatory disease,
- Pregnant women
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: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Active Comparator: true taping+ exercise
The true taping method was applied to the first group according to the method determined by Kase.
According to this method, a 2-inch (5 cm) wide beige-colored Kinesio tape (Kinesio® Tex Gold FP) was measured from the second-third metacarpal base to the lateral epicondyle while the elbow was extended and the wrist was in the neutral position and the tape was applied in the shape of a 'Y'.
In a position where the wrist-ankle extensors were most tense (wrist-ankle extension - forearm pronation), the anchor point of the tape was applied to the insertion of the muscle without creating any tension.
Then, the tape was applied to the medial and lateral edges of the wrist extensors by applying a 15-25% tension towards the origin of the muscle.
Both ends of the Y-shaped tape were terminated without tension on the lateral epicondyle.
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The tape is an elastic cotton strip with an acrylic adhesive that is used with the intent of treating pain and disability
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Placebo Comparator: sham taping+exercise
In the placebo group, the 10 cm I-shaped tape was placed 5 cm inferior to the lateral epicondyle using the same Kinesio tape in the study group.
It was applied transversely, starting from the painless side of the midline on the forearm extensor face directing towards the lateral side of the forearm without a tension.
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The tape is an elastic cotton strip with an acrylic adhesive that is used with the intent of treating pain and disability
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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numerical rating scale
Time Frame: 1 year
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The numerical rating scale (NRS) was used to evaluate the pain level of the patients included in the study.
It is a one-dimensional scale consisting of 11 items that measure pain intensity in adults and is a segmented - intermittent numerical version of the visual analogue scale (VAS).
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1 year
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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resisted muscle test evaluation
Time Frame: 1 year
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According to the Cyriax method, each joint tested was kept in the mid- range of motion, without allowing movement.
Resistance was applied to the forearm distal to avoid muscle involvement other than that tested in pronation and supination, thus the wrist was prevented to be involved.
Subsequently, the patients were asked to apply a maximum force for at least three seconds.
Resisted wrist extension, third finger extension, elbow supination, and pronation were evaluated.
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1 year
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Maximal Isometric Handgrip Strength
Time Frame: 1 year
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The maximal isometric handgrip strength was measured in pounds using the Jamar hand dynamometer (Baseline® Hand Dynamometer - HiRes™ Gauge - ER™ 300 lbCapacity).
Measurement was performed in two different positions, elbow at extension and 90° flexion.
In the first position, the patient was in the sitting position, shoulder abducted to 0° and in neutral rotation, elbow position was at 90° flexion, the forearm was in neutral rotation and wrist was in the neutral position.
In the second position, while the patient was standing, shoulder abducted to 0° and in neutral rotation, the elbow was in full extension, forearm and wrist were in the neutral position.
The patient was asked to squeeze the dynamometer with full force for three seconds every 30 seconds.
This procedure was repeated three times and the mean measurement values were obtained
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1 year
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The Patient-rated Tennis Elbow Evaluation(PRTEE)
Time Frame: 1 year
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The Patient-rated Tennis Elbow Evaluation (PRTEE) is a questionnaire with subscales related to pain and function, which is used to evaluate upper extremity functionality.
It is specially prepared for patients with lateral epicondylitis.Scoring ranges from 0 (no pain/disability) to 100 (worst possible pain and disability).
The total score can be 100 points maximum and low scores refer to better functionality.Turkish validity and reliability was proven by Altan et al.
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1 year
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36-Item Short-Form Health Survey (SF-36)
Time Frame: 1 year
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The SF-36 is valid and reliable for patients with chronic musculoskeletal disorders.
The items include eight different domains that indicate physical functioning, physical role limitation, pain, general health, vitality, social functioning, emotional role limitation, and mental health.
The score of each domain ranges from 0 (worst quality of life) to 100 (the best quality of life).
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1 year
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: IŞIL S YENİCE BALEVİ, Gazi University
- Study Director: BELGİN KARAOĞLAN, Gazi University
- Principal Investigator: NAGİHAN ACET, Gazi University
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)
February 1, 2017
Primary Completion (Actual)
May 1, 2017
Study Completion (Actual)
July 1, 2017
Study Registration Dates
First Submitted
August 12, 2020
First Submitted That Met QC Criteria
August 14, 2020
First Posted (Actual)
August 19, 2020
Study Record Updates
Last Update Posted (Actual)
August 19, 2020
Last Update Submitted That Met QC Criteria
August 14, 2020
Last Verified
February 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GaziU
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
IPD Plan Description
Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
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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