- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06611709
Effectiveness of the Kinesiotaping in the Treatment of Chronic Lateral Epicondylitis
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
Status
Conditions
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Selçuklu
-
Konya, Selçuklu, Turkey, 42060
- Konya Beyhekim Research and Training Hospital, Physical Medicine and Rehabilitation clinics
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
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
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
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- KonyaBeyhekimTRH2024
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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