Effectiveness of the Kinesiotaping in the Treatment of Chronic Lateral Epicondylitis

September 20, 2024 updated by: Ramazan Yılmaz, Konya Beyhekim Training and Research Hospital

Effectiveness of the Kinesiotaping in the Treatment of Chronic Lateral Epicondylitis: a Randomized, Sham-controlled, Single-blind Study

Lateral epicondylitis significantly impacts daily activities and productivity at work, making it a condition of substantial clinical and socioeconomic importance.Despite its high prevalence, clinical significance, and impact on daily life, the optimal management of LE remains a topic of ongoing debate.

This study aims to investigate the efficacy of kinesiotaping (KT) on pain intensity, functional status, and quality of life in patients with chronic lateral epicondylitis (LE).

The study was conducted in the outpatient clinic for level 3 physical medicine and rehabilitation. Patients were randomized into two groups: the real kinesiotaping + home exercise group and the sham taping + home exercise group (randomized by a medical secretary outside the study). A set of widely accepted, literature-consistent primer and seconder outcomes were statistically compared to determine whether one treatment was superior to the other.

Study Overview

Detailed Description

Between February 1, 2024, and August 31, 2024, a total of 42 patients (17 females, 25 males) with chronic LE were included. Patients were randomized into either the KT or sham-controlled group. Patients were blinded to which group they were assigned to. The taping was performed by the same physician, who was trained and experienced in kinesiotaping.

Kinesiotaping and sham-taping were applied six times over three weeks. Both groups received recommendations for activity modification and a home-based stretching and strengthening exercise program. The exercise program was designed by an author who has a national book chapter on exercise for the treatment of lateral epicondylitis, taking into account patient specificity and adherence, and in accordance with the literaturExercise adherence was monitored through weekly outpatient controls (while taping) and by phone check-ins two weeks after the taping was completed.

Outcome measures were visual analog scale (VAS) pain score, Patient-Rated Forearm Evaluation Questionnaire (PRFEQ), grip strength, Disabilities of Arm, Shoulder, and Hand (DASH), quality of life in Short Form-36 (SF-36), and The Roles and Maudsley patient satisfaction score. The subjects were assessed before treatment, at the end of treatment (week three), and four weeks after the end of treatment (week seven).The assessment parameters were also conducted by the same researcher to ensure consistency.

Study Type

Interventional

Enrollment (Actual)

42

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

    • Selçuklu
      • Konya, Selçuklu, Turkey, 42060
        • Konya Beyhekim Research and Training Hospital, Physical Medicine and Rehabilitation clinics

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adults aged 18 to 65 years
  • A pain severity of 4 or higher on the visual analog scale (VAS) during daily activities
  • A history of lateral epicondylitis symptoms lasting at least three months

Exclusion Criteria:

  • Communication difficulties
  • Significant psychiatric disorders
  • A history of trauma within the past six months
  • Neuromuscular conditions
  • Abnormalities of the upper limb
  • Prior upper limb surgery
  • A history of rheumatic diseases
  • Cervical disc pathology, polyneuropathy, or hand disorders (such as carpal or cubital tunnel syndrome, de Quervain tenosynovitis, osteoarthritis)
  • Receipt of any treatment for lateral epicondylitis (e.g., local injections, physical therapy, splints) within the last six month

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Kinesiotaping
Kinesiotaping (real) + exercises
A standard 5-cm wide KinesioⓇ Tex Gold
home-based exercises
Sham Comparator: Sham-taping
Sham-taping (non-elastic medical cloth tape) + exercises
home-based exercises
sham taping

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient-Rated Tennis Elbow Evaluation Questionnaire (PRTEE)
Time Frame: baseline, week 3, and week 7
0 (best) to 100 (worst)
baseline, week 3, and week 7
VAS pain (0-10)
Time Frame: baseline, week 3, and week 7
0 no pain; 10 unbearable/max. pain.
baseline, week 3, and week 7

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Disabilities of the Arm, Shoulder, and Hand (DASH)
Time Frame: baseline, week 3, and week 7
0 (best condition) to 100 (worst condition)
baseline, week 3, and week 7
grip strength
Time Frame: baseline, week 3, and week 7
using a Jamar® dynamometer (in kilograms)
baseline, week 3, and week 7
The Short Form-36 (SF-36) quality of life index
Time Frame: baseline, week 3, and week 7
0, indicating the worst health status, to 100, representing the best possible health
baseline, week 3, and week 7
Patient satisfaction/benefit scale (The Roles and Maudsley score)
Time Frame: baseline, week 3, and week 7
The Roles and Maudsley score was utilized to evaluate pain and activity limitations in the assessment of treatment efficacy, categorized into four levels: 1 point indicating excellent, 2 points indicating good, 3 points indicating fair, and 4 points indicating poor.
baseline, week 3, and week 7

Collaborators and Investigators

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

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, 2024

Primary Completion (Actual)

August 31, 2024

Study Completion (Actual)

September 1, 2024

Study Registration Dates

First Submitted

September 18, 2024

First Submitted That Met QC Criteria

September 20, 2024

First Posted (Actual)

September 25, 2024

Study Record Updates

Last Update Posted (Actual)

September 25, 2024

Last Update Submitted That Met QC Criteria

September 20, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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