Effect of Percutaneous Electrolysis Combined With Exercise on Pain and Function in Chronic Lateral Epicondylitis

NCT07277127 | Completed

• 1 other identifier: EPTE-001-S
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief 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. 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

Outcome Measures

Primary Outcomes (1)

• Change in Pain Intensity (VAS)

  Pain intensity will be measured using a 10-cm Visual Analog Scale (VAS).

  Baseline, 1 week post-treatment, 1 month, 3 months

Secondary Outcomes (3)

• Change in Pressure Pain Threshold (Algometry)

  Baseline, 1 week post-treatment, 1 month, 3 months

• Change in Functional Status (PRTEE Score)

  Baseline, 1 week post-treatment, 1 month, 3 months

• Change in Upper Limb Function (QuickDASH)

  Baseline, 1 week post-treatment, 1 month, 3 months

Study Arms (2)

Exercise

ACTIVE COMPARATOR

Participants perform a 2-week exercise program including stretching and eccentric strengthening exercises for the wrist extensor and forearm muscles.

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.

Other: Exercise; Device: Percutaneous Electrolysis

Interventions

Exercise OTHER

2-week exercise program with stretching and eccentric strengthening for wrist extensors and forearm muscles.

Exercise; Percutaneous Electrolysis plus Exercise

Percutaneous Electrolysis DEVICE

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.

Percutaneous Electrolysis plus Exercise

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sivas State Hospital: lead

Study Sites (1)

Sivas State Hospital

Sivas, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Tennis Elbow

Interventions

Exercise

Condition Hierarchy (Ancestors)

Elbow Tendinopathy; Tendinopathy; Muscular Diseases; Musculoskeletal Diseases; Elbow Injuries; Arm Injuries; Wounds and Injuries; Tendon Injuries

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: November 30, 2025
• First Posted: December 11, 2025
• Study Start: September 5, 2025
• Primary Completion: March 5, 2026
• Study Completion: March 5, 2026
• Last Updated: March 17, 2026

Record last verified: 2025-10

Locations

TU (1)