- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07420764
Comparison Of The Effectiveness Of Wrist Splint And Kinesiotaping Treatments In Patients With Lateral Epicondylitis
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This study was designed as a prospective, randomized, controlled clinical trial to compare the effectiveness of wrist splint and kinesiotaping treatments in patients diagnosed with lateral epicondylitis.
A total of 150 patients aged between 18 and 65 years who were clinically diagnosed with lateral epicondylitis were included in the study. Patients were randomly allocated into three groups: the kinesiotaping group, the wrist splint group, and the control group, with 50 patients in each group.
The kinesiotaping group received kinesiotaping applications twice a week for a total of six sessions using muscle inhibition and epidermis-dermis-fascia (EDF) techniques. The wrist splint group was instructed to use a static wrist-hand splint for three weeks. The control group received cold application and a home exercise program.
All groups were provided with standardized cold application and home exercise programs. Patients were evaluated at baseline, at the end of treatment, and at the fourth week after treatment. Outcome measures included pain intensity assessed by the Visual Analog Scale (VAS), grip strength measured with a Jamar dynamometer, functional status assessed using the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire and the Patient-Rated Tennis Elbow Evaluation (PRTEE), quality of life assessed with the Short Form-36 (SF-36), and treatment satisfaction evaluated using the Roles and Maudsley score.
The primary objective of this study was to compare the effects of kinesiotaping using muscle inhibition and epidermis-dermis-fascia techniques and wrist splint use on pain, functional outcomes, grip strength, and quality of life in patients with lateral epicondylitis.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Konya
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Konya, Konya, Turkey (Türkiye), 42200
- Konya Beyhekim Training and Research Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age 18-65 years
- Clinically diagnosed lateral epicondylitis
- Elbow pain for at least 3 months
- Ability to understand and comply with study procedures
- Written informed consent provided
Exclusion Criteria:
- Previous surgery to the affected elbow
- Corticosteroid injection to the affected elbow within the last 6 months
- Neurological disorders affecting the upper extremity
- Inflammatory rheumatic diseases and fibromyalgia
- Fracture or trauma of the upper extremity within the last 6 months
- Pregnancy
- Participation in another clinical study during the study period
Study Plan
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 |
|---|---|
|
Other: Kinesiotaping
Participants received kinesiotaping treatment in addition to standard cold application and a home exercise program.
|
Kinesiotaping was applied twice a week for a total of six sessions using muscle inhibition and epidermis-dermis-fascia (EDF) techniques.
In addition, participants received standardized cold application and a home exercise program.
Participants received standardized cold application and a home exercise program without kinesiotaping or splint use.
|
|
Other: Wrist-Hand Splint
Participants used a static wrist-hand splint in addition to standard cold application and a home exercise program.
|
Participants received standardized cold application and a home exercise program without kinesiotaping or splint use.
Participants were instructed to use a static wrist-hand splint for three weeks to maintain the wrist in a slightly extended position.
Standardized cold application and a home exercise program were also provided.
|
|
Other: Control Group
Participants received conservative treatment consisting of cold application and a home exercise program.
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Participants received standardized cold application and a home exercise program without kinesiotaping or splint use.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain intensity
Time Frame: All assessments were conducted by the same evaluator at baseline, at the end of the 3-week treatment period, and 4 weeks following treatment completion.
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Pain intensity was assessed using a 10-cm Visual Analog Scale (VAS), ranging from 0 (no pain) to 10 (worst imaginable pain).
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All assessments were conducted by the same evaluator at baseline, at the end of the 3-week treatment period, and 4 weeks following treatment completion.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Grip strength
Time Frame: All assessments were conducted by the same evaluator at baseline, at the end of the 3-week treatment period, and 4 weeks following treatment completion.
|
Grip strength was assessed using a Jamar dynamometer.
Participants were seated with the shoulder in adduction, the elbow flexed at 90°, and the forearm positioned in neutral rotation between supination and pronation.
Measurements were performed using the second and third handle settings of the dynamometer.
Three consecutive trials were conducted, and the mean value was calculated and recorded in kilograms.
|
All assessments were conducted by the same evaluator at baseline, at the end of the 3-week treatment period, and 4 weeks following treatment completion.
|
|
Upper extremity function
Time Frame: All assessments were conducted by the same evaluator at baseline, at the end of the 3-week treatment period, and 4 weeks following treatment completion.
|
Upper extremity function and symptoms were evaluated using the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire.
The 30-item core section (DASH-FS) was used to assess functional status and symptom severity.
In addition, the optional Work (DASH-W) and Sports/Music (DASH-SM) modules were administered when applicable.
All items were scored on a 5-point Likert scale, and scores were calculated on a 0-100 scale, with higher scores indicating greater disability.
The Turkish version of the DASH, which has established validity and reliability, was used in this study.
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All assessments were conducted by the same evaluator at baseline, at the end of the 3-week treatment period, and 4 weeks following treatment completion.
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Health-related quality of life
Time Frame: All assessments were conducted by the same evaluator at baseline, at the end of the 3-week treatment period, and 4 weeks following treatment completion.
|
Health-related quality of life was assessed using the 36-Item Short Form Health Survey (SF-36).
The questionnaire evaluates eight domains, including physical functioning, role limitations due to physical and emotional problems, bodily pain, general health perception, vitality, social functioning, and mental health.
Each domain is scored on a scale from 0 to 100, with higher scores indicating better perceived health status.
|
All assessments were conducted by the same evaluator at baseline, at the end of the 3-week treatment period, and 4 weeks following treatment completion.
|
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Treatment satisfaction
Time Frame: All assessments were conducted by the same evaluator at the end of the 3-week treatment period, and 4 weeks following treatment completion.
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Patient satisfaction with treatment will be evaluated using the Roles and Maudsley scoring system.
Post-treatment outcomes will be classified into four categories: excellent, good, acceptable, and poor.
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All assessments were conducted by the same evaluator at the end of the 3-week treatment period, and 4 weeks following treatment completion.
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Patient-Rated Forearm Evaluation Questionnaire) (PRFEQ)
Time Frame: All assessments were conducted by the same evaluator at baseline, at the end of the 3-week treatment period, and 4 weeks following treatment completion.
|
The Patient-Rated Forearm Evaluation Questionnaire (PRFEQ), a scoring system with established Turkish validity and reliability, was used to assess arm-related pain and functional status over the previous week (19).
The questionnaire evaluates pain with 5 items and function with 10 items.
Pain items are scored on a 0-10 cm Visual Analog Scale (VAS), ranging from 0 (no pain) to 10 (worst imaginable pain).
Functional items are also scored on a 0-10 cm VAS, ranging from 0 (extreme difficulty) to 10 (no difficulty).
Mean pain and function scores, as well as the total score, are calculated for analysis.
|
All assessments were conducted by the same evaluator at baseline, at the end of the 3-week treatment period, and 4 weeks following treatment completion.
|
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- Konya Beyhekim TRH
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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