Lateral EpicondylitisNCT07277127
Effect of Percutaneous Electrolysis Combined With Exercise on Pain and Function in Chronic Lateral Epicondylitis
A study testing Exercise and Percutaneous Electrolysis in people with Lateral Epicondylitis, run by Sivas State Hospital at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Lateral Epicondylitis
- What is being tested?
- Exercise and Percutaneous Electrolysis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Sep 2025to 5 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Lateral Epicondylitis
- Being tested
- Exercise, Percutaneous Electrolysis
- Medical subject headings
- Tennis Elbow
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
2-week exercise program with stretching and eccentric strengthening for wrist extensors and forearm muscles.
Percutaneous ElectrolysisDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Exercise | Active comparator | Participants perform a 2-week exercise program including stretching and eccentric strengthening exercises for the wrist extensor and forearm muscles. Receives: Other: Exercise |
| Percutaneous Electrolysis plus Exercise | Experimental | 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. Receives: Other: Exercise; Device: Percutaneous Electrolysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pain Intensity (VAS)
Pain intensity will be measured using a 10-cm Visual Analog Scale (VAS).
Measured: Baseline, 1 week post-treatment, 1 month, 3 months
Secondary outcomes (3)
Change in Pressure Pain Threshold (Algometry)
Pressure pain threshold over the common extensor tendon will be measured using a handheld algometer.
Measured: Baseline, 1 week post-treatment, 1 month, 3 months
Change in Functional Status (PRTEE Score)
Functional disability and pain will be assessed using the Patient-Rated Tennis Elbow Evaluation (PRTEE).
Measured: Baseline, 1 week post-treatment, 1 month, 3 months
Change in Upper Limb Function (QuickDASH)
Upper limb disability will be evaluated using the Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) questionnaire.
Measured: Baseline, 1 week post-treatment, 1 month, 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2025
- Study start5 Sep 2025
- Primary completion5 Mar 2026
- Study completion5 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lateral EpicondylitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sivas State Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Serkan Polat, Sivas State Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07277127
- Sponsor's protocol ID
- EPTE-001-S
- Status last verified
- Oct 2025
- First submitted
- 30 Nov 2025
- Last updated
- 17 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Percutaneous Electrolysis Combined With Exercise on Pain and Function in Chronic Lateral Epicondylitis: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07277127
- Acronym / sponsor ID
- EPTE-001-S
- Conditions
- Lateral Epicondylitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Sivas State HospitalUniversity, hospital or other
- Study start
- 5 Sep 2025 (actual)
- Primary completion
- 5 Mar 2026 (actual)
- Study completion
- 5 Mar 2026 (actual)
- First posted
- 11 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise | Active comparator | Other: ExerciseParticipants perform a 2-week exercise program including stretching and eccentric strengthening exercises for the wrist extensor and forearm muscles. |
| Percutaneous Electrolysis plus Exercise | Experimental | Other: Exercise, Device: Percutaneous ElectrolysisParticipants 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise2-week exercise program with stretching and eccentric strengthening for wrist extensors and forearm muscles. | Other | Exercise, Percutaneous Electrolysis plus Exercise |
| Percutaneous ElectrolysisParticipants 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. | Device | Percutaneous Electrolysis plus Exercise |
Primary outcome
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).
3 secondary outcomes
Change in Pressure Pain Threshold (Algometry)
Time frame: 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
Change in Upper Limb Function (QuickDASH)
Time frame: Baseline, 1 week post-treatment, 1 month, 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise and Percutaneous Electrolysis in people with Lateral Epicondylitis, run by Sivas State Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pain Intensity (VAS) (time frame: Baseline, 1 week post-treatment, 1 month, 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2026.