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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
68

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Exercise
Participants perform a 2-week exercise program including stretching and eccentric strengthening exercises for the wrist extensor and forearm muscles.
Other: Exercise
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.
Other: Exercise
2-week exercise program with stretching and eccentric strengthening for wrist extensors and forearm muscles.
Device: Percutaneous Electrolysis
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sivas State Hospital

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 5, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 5, 2026

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 5, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 30, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 30, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 11, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 17, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 16, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings