- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07028840
- Original Trial
Physiotherapy Applications in Lateral Epicondylitis
A Comparison of Extracorporeal Shockwave Therapy (ESWT) and High-intensity Laser Therapy (HILT) in Terms of Pain, Function and Grip Strength in Lateral Epicondilitis: a Randomized Controlled Study
Study Overview
Status
Conditions
Detailed Description
This randomized controlled clinical trial investigates the effects of extracorporeal shock wave therapy (ESWT) and high-intensity laser therapy (HILT) on pain, grip strength, and function in patients diagnosed with lateral epicondylitis. The study was conducted at the physical medicine polyclinic of Balıkesir Private Sevgi Hospital and included 42 patients aged 18 to 65 who were referred for therapeutic physical therapy after being diagnosed for the first time with lateral epicondylitis.
Participants were randomly divided into three groups:
Group 1: received conventional physiotherapy including hot pack application, transcutaneous electric nerve stimulation (TENS), and stretching/strengthening exercises. Physiotherapy was administered 5 times per week for 2 weeks (total of 10 sessions).
Group 2: received the same physiotherapy as group 1, plus extracorporeal shock wave therapy (ESWT) administered twice per week for 2 weeks (total of 4 sessions).
Group 3: received the same physiotherapy as group 1, plus high-intensity laser therapy (HILT) administered twice per week for 2 weeks (total of 4 sessions).
Pain severity was evaluated using the visual analog scale (VAS), grip strength using a hand dynamometer, and functional status using the Duruöz Hand Index and patient-rated tennis elbow evaluation (PRTEE-T). All outcome measures were assessed at three time points: baseline (before treatment), post-treatment (after 2 weeks), and at 1-month follow-up. The primary objective was to assess whether either ESWT or HILT offers additional benefit over standard physiotherapy and whether one modality is superior to the other in treating lateral epicondylitis.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Denizli, Turkey
- Pamukkale University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Being over the age of 18,
- Being diagnosed with lateral epicondylitis,
- Not having received lateral epicondylitis treatment in the last 3 months
Exclusion Criteria:
- Stopping the treatment,
- Those who have been traumatized in the last 3 months,
- Those who use drugs that can affect muscle strength or pain level (muscle relaxants, analgesics, gabapentinoids, etc.)
- Those with open wounds in the elbow area, Those with elbow fractures, Those with drug allergies, Pregnant and breastfeeding women.
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 |
|---|---|
|
Active Comparator: Physiotherapy
This group received conventional physiotherapy only
|
10 sessions over 2 weeks, including TENS, cold therapy, ultrasound, and exercise therapy, 5 sessions per week.
|
|
Active Comparator: Physiotherapy + ESWT
This group received conventional physiotherapy and additional extracorporeal shock wave therapy (ESWT)
|
10 sessions over 2 weeks, including TENS, cold therapy, ultrasound, and exercise therapy, 5 sessions per week.
4 sessions total, applied 2 times per week for 2 weeks.
|
|
Active Comparator: Physiotherapy + HILT
This group received conventional physiotherapy and additional high-intensity laser therapy (HILT).
|
10 sessions over 2 weeks, including TENS, cold therapy, ultrasound, and exercise therapy, 5 sessions per week.
4 sessions total, applied 2 times per week for 2 weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain Severity - Visual Analog Scale (VAS)
Time Frame: Baseline (Day 1), at the end of 2-week treatment, 4 weeks after treatment completion
|
Pain intensity will be evaluated using the visual analog scale (VAS), a 10 cm line ranging from 0 (no pain) to 10 (worst imaginable pain).
Continuous scale (0-10), higher scores indicate worse outcome.
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Baseline (Day 1), at the end of 2-week treatment, 4 weeks after treatment completion
|
|
Grip Strength - Hand Dynamometer
Time Frame: Baseline (Day 1), at the end of 2-week treatment, 4 weeks after treatment completion
|
Grip strength will be measured in kilograms using a hand dynamometer.
Continuous scale, higher scores indicate better outcome
|
Baseline (Day 1), at the end of 2-week treatment, 4 weeks after treatment completion
|
|
Upper Extremity Function - Duruöz Hand Index
Time Frame: Baseline (Day 1), at the end of 2-week treatment, 4 weeks after treatment completion
|
The Duruöz Hand Index is a functional scale that assesses hand-related disability.
Scores range from 0 to 90, with higher scores indicating worse functional impairment.
|
Baseline (Day 1), at the end of 2-week treatment, 4 weeks after treatment completion
|
|
Functional Evaluation - PRTEE-T (Patient-Rated Tennis Elbow Evaluation)
Time Frame: Baseline (Day 1), at the end of 2-week treatment, 4 weeks after treatment completion
|
The PRTEE-T is a 15-item patient-rated questionnaire for lateral epicondylitis.
Total scores range from 0 (no disability) to 100 (maximum disability).
Continuous scale (0-100), higher scores indicate worse outcome.
|
Baseline (Day 1), at the end of 2-week treatment, 4 weeks after treatment completion
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: SUAT EREL, PROF.DR., Pamukkale University
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 (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 674325
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
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.
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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