Percutaneous Electrolysis of the Upper Trapezius in Chronic Neck Pain

NCT ID: NCT07294651

Last Updated: 2025-12-19

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-01
• Study Completion Date: 2026-04-10

Brief Summary

In the planned study, we aim to investigate the effectiveness of percutaneous electrolysis treatment applied to myofascial trigger points in the upper trapezius muscle in patients with chronic neck pain. Two different protocols, a low-intensity (0.5 mA × 90 s) and a high-intensity (3 mA × 3 s × 3 repetitions), will be compared in the study.

Patients participating in the research will be randomized into 2 groups using a computer program. Stretching exercises targeting the upper trapezius muscle will be given to both groups as a home exercise program. In both groups, the percutaneous electrolysis treatment protocol will be performed on the active myofascial trigger points in the upper trapezius muscle on the 1st, 8th, and 14th days of treatment, using 0.3-millimeter acupuncture needles and an EPTE® percutaneous electrolysis device (Ionclinics & A. Deionic SL, Valencia, Spain). The low-intensity (0.5 milliampere × 90 s) treatment protocol will be applied to Group 1, and the high-intensity (3 milliampere × 3 s × 3 repetitions) treatment protocol will be applied to Group 2. In the study, two different protocols, low-intensity (0.5 mA × 90 s) and high-intensity (3 mA × 3 s × 3 repetitions), will be compared. In this way, it is aimed both to obtain information about optimal dosing and to contribute to the literature for a frequently involved muscle such as the upper trapezius.

Conditions

Myofascial Pain of Upper Trapezius Muscle

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Low-Intensity Percutaneous Electrolysis of the Upper Trapezius plus Exercise

Participants receive a home-based stretching exercise program targeting the upper trapezius muscle, plus three sessions of ultrasound-guided percutaneous electrolysis applied to the active myofascial trigger points of the upper trapezius muscle on days 1, 8, and 14. Percutaneous electrolysis is delivered using 0.3-mm acupuncture needles and an EPTE® percutaneous electrolysis device with a low-intensity protocol (0.5 mA for 90 seconds per session).

Interventions:

Low-Intensity Percutaneous Electrolysis of the Upper Trapezius

Upper Trapezius Stretching Exercise Program

Group Type: ACTIVE_COMPARATOR

Low-Intensity Percutaneous Electrolysis of the Upper Trapezius

Intervention Type: DEVICE

Ultrasound-guided percutaneous electrolysis applied to the active myofascial trigger points of the upper trapezius muscle using 0.3-mm acupuncture needles and an EPTE® percutaneous electrolysis device. A low-intensity protocol is used (0.5 mA for 90 seconds per session) on days 1, 8, and 14.

Upper Trapezius Stretching Exercise Program

Intervention Type: OTHER

Home-based stretching exercise program targeting the upper trapezius muscle throughout the treatment period in both groups.

High-Intensity Percutaneous Electrolysis of the Upper Trapezius plus Exercise

Participants receive the same home-based stretching exercise program targeting the upper trapezius muscle as the active comparator group, plus three sessions of ultrasound-guided percutaneous electrolysis applied to the active myofascial trigger points of the upper trapezius muscle on days 1, 8, and 14. Percutaneous electrolysis is delivered using 0.3-mm acupuncture needles and an EPTE® percutaneous electrolysis device with a high-intensity protocol (3 mA for 3 seconds, repeated 3 times per session).

Interventions:

High-Intensity Percutaneous Electrolysis of the Upper Trapezius

Upper Trapezius Stretching Exercise Program

Group Type: EXPERIMENTAL

High-Intensity Percutaneous Electrolysis of the Upper Trapezius

Intervention Type: DEVICE

Ultrasound-guided percutaneous electrolysis applied to the active myofascial trigger points of the upper trapezius muscle using 0.3-mm acupuncture needles and an EPTE® percutaneous electrolysis device. A high-intensity protocol is used (3 mA for 3 seconds, repeated 3 times per session) on days 1, 8, and 14.

Upper Trapezius Stretching Exercise Program

Intervention Type: OTHER

Home-based stretching exercise program targeting the upper trapezius muscle throughout the treatment period in both groups.

Interventions

Low-Intensity Percutaneous Electrolysis of the Upper Trapezius

Ultrasound-guided percutaneous electrolysis applied to the active myofascial trigger points of the upper trapezius muscle using 0.3-mm acupuncture needles and an EPTE® percutaneous electrolysis device. A low-intensity protocol is used (0.5 mA for 90 seconds per session) on days 1, 8, and 14.

Intervention Type: DEVICE

High-Intensity Percutaneous Electrolysis of the Upper Trapezius

Ultrasound-guided percutaneous electrolysis applied to the active myofascial trigger points of the upper trapezius muscle using 0.3-mm acupuncture needles and an EPTE® percutaneous electrolysis device. A high-intensity protocol is used (3 mA for 3 seconds, repeated 3 times per session) on days 1, 8, and 14.

Intervention Type: DEVICE

Upper Trapezius Stretching Exercise Program

Home-based stretching exercise program targeting the upper trapezius muscle throughout the treatment period in both groups.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

Patients who agree to participate in the study, are between 18 and 70 years of age, have had symptoms for at least 3 months, and have chronic neck pain with active myofascial trigger points in the upper trapezius muscle will be included.

Exclusion Criteria

Patients with malignancy, active infection, a history of widespread inflammatory rheumatic disease or fibromyalgia, trauma, skin lesions, infection or open wounds at the myofascial trigger point region, coagulopathy, warfarin use, a history of spinal or shoulder disorders, previous neck or upper extremity surgery, acute illness, muscle diseases, epilepsy, use of sedative medications, needle phobia, previous dry needling treatment for myofascial pain, a cardiac pacemaker, metal implants in the treatment area, conditions that contraindicate physiotherapy such as pregnancy, or metal allergy will not be included in the study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sivas State Hospital

OTHER

Sponsor Role: lead

Responsible Party

Serkan Polat

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Sivas Devlet Hastanesi

Sivas, , Turkey (Türkiye)

Site Status: RECRUITING

Countries

Turkey (Türkiye)

Facility Contacts

Serkan Polat, MD

Role: primary

Other Identifiers

EPTE-MAS-001-S

Identifier Type: -

Identifier Source: org_study_id