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

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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
      • Ankara, Turkey
        • Gazi University

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Device: Tape
The tape is an elastic cotton strip with an acrylic adhesive that is used with the intent of treating pain and disability
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.
Device: Tape
The tape is an elastic cotton strip with an acrylic adhesive that is used with the intent of treating pain and disability

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
numerical rating scale
Time Frame: 1 year
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).
1 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
resisted muscle test evaluation
Time Frame: 1 year
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.
1 year
Maximal Isometric Handgrip Strength
Time Frame: 1 year
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
1 year
The Patient-rated Tennis Elbow Evaluation(PRTEE)
Time Frame: 1 year
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.
1 year
36-Item Short-Form Health Survey (SF-36)
Time Frame: 1 year
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).
1 year

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Elif Balevi Batur

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 12, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 14, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 19, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 19, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 14, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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