- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07277127
Effect of Percutaneous Electrolysis Combined With Exercise on Pain and Function in Chronic Lateral Epicondylitis
March 16, 2026 updated by: Serkan Polat, Sivas State Hospital
Effect of Percutaneous Electrolysis Combined With Exercise on Pain and Function in Chronic Lateral Epicondylitis: A Randomized Controlled Trial
The aim of this randomized controlled trial is to compare the effects of percutaneous electrolysis combined with exercise versus exercise alone on pain and function in patients with chronic lateral epicondylitis.
Participants will be randomly allocated into two parallel groups.
The control group will receive a 2-week exercise program including stretching and eccentric strengthening exercises for the wrist extensor and forearm muscles.
The experimental group will receive the same exercise program plus three sessions of ultrasound-guided percutaneous electrolysis applied to the extensor carpi radialis brevis tendon insertion at the lateral epicondyle (on days 1, 8, and 14).
Clinical outcomes will be assessed using a 10-cm Visual Analog Scale (VAS) for pain intensity, pressure pain threshold over the common extensor tendon measured with a handheld algometer, the Patient-Rated Tennis Elbow Evaluation (PRTEE) questionnaire for pain and functional disability, and the Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) questionnaire for upper limb function.
Assessments will be performed at baseline, and then at 1 week, 1 month, and 3 months after the end of the 2-week treatment period.
The study aims to determine whether adding percutaneous electrolysis to an exercise program provides greater improvement in pain and functional status than exercise alone in patients with chronic lateral epicondylitis.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
68
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
-
-
-
Sivas, Turkey (Türkiye)
- Sivas State Hospital
-
-
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:
- Age between 18 and 65 years
- Clinically and MRI-confirmed diagnosis of chronic lateral epicondylitis (symptoms ≥ 3 months)
- Ability and willingness to comply with the treatment protocol and follow-up schedule
Exclusion Criteria:
- Previous elbow surgery or fracture in the affected limb
- Local corticosteroid injection or other invasive treatment in the past 3 months
- Cervical radiculopathy, systemic rheumatic disease, or other neurological disorders affecting the upper limb
- Presence of a cardiac pacemaker or diagnosis of epilepsy
- Pregnancy or breastfeeding
- Serious bleeding disorder (coagulopathy) or current anticoagulant therapy
- Inability to follow the exercise protocol or attend follow-up visits
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 |
Intervention / Treatment |
|---|---|
|
Active Comparator: Exercise
Participants perform a 2-week exercise program including stretching and eccentric strengthening exercises for the wrist extensor and forearm muscles.
|
2-week exercise program with stretching and eccentric strengthening for wrist extensors and forearm muscles.
|
|
Experimental: Percutaneous Electrolysis plus Exercise
Participants receive the same 2-week exercise program as the control group plus three sessions of ultrasound-guided percutaneous electrolysis applied to the extensor carpi radialis brevis tendon insertion at the lateral epicondyle on days 1, 8, and 14.
|
2-week exercise program with stretching and eccentric strengthening for wrist extensors and forearm muscles.
Participants receive the same 2-week exercise program as the control group plus three sessions of ultrasound-guided percutaneous electrolysis applied to the extensor carpi radialis brevis tendon insertion at the lateral epicondyle on days 1, 8, and 14.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Pain Intensity (VAS)
Time Frame: Baseline, 1 week post-treatment, 1 month, 3 months
|
Pain intensity will be measured using a 10-cm Visual Analog Scale (VAS).
|
Baseline, 1 week post-treatment, 1 month, 3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Pressure Pain Threshold (Algometry)
Time Frame: Baseline, 1 week post-treatment, 1 month, 3 months
|
Pressure pain threshold over the common extensor tendon will be measured using a handheld algometer.
|
Baseline, 1 week post-treatment, 1 month, 3 months
|
|
Change in Functional Status (PRTEE Score)
Time Frame: Baseline, 1 week post-treatment, 1 month, 3 months
|
Functional disability and pain will be assessed using the Patient-Rated Tennis Elbow Evaluation (PRTEE).
|
Baseline, 1 week post-treatment, 1 month, 3 months
|
|
Change in Upper Limb Function (QuickDASH)
Time Frame: Baseline, 1 week post-treatment, 1 month, 3 months
|
Upper limb disability will be evaluated using the Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) questionnaire.
|
Baseline, 1 week post-treatment, 1 month, 3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
September 5, 2025
Primary Completion (Actual)
March 5, 2026
Study Completion (Actual)
March 5, 2026
Study Registration Dates
First Submitted
November 30, 2025
First Submitted That Met QC Criteria
November 30, 2025
First Posted (Actual)
December 11, 2025
Study Record Updates
Last Update Posted (Actual)
March 17, 2026
Last Update Submitted That Met QC Criteria
March 16, 2026
Last Verified
October 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EPTE-001-S
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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