Percutaneous Electrolysis of the Upper Trapezius in Chronic Neck Pain

NCT07294651 | Recruiting

• 1 other identifier: EPTE-MAS-001-S
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Change in Pain Intensity (VAS)

  Pain intensity related to plantar heel pain will be assessed using a 10-cm Visual Analog Scale (VAS). Higher scores indicate greater pain.

  Baseline (before treatment), immediately after completion of the 3rd treatment session (approximately 2 weeks), and 3 months after treatment initiation.

Secondary Outcomes (2)

• Change in Pressure Pain Threshold (Algometry)

  Baseline, post-treatment (approximately 2 weeks), and 3 months after treatment initiation.

• Change in Functional Disability (Modified Neck Disability Index)

  Baseline (prior to the first treatment session), immediately after completion of treatment (after the third session, approximately 2 weeks from baseline), and 3 months after treatment initiation.

Study Arms (2)

Low-Intensity Percutaneous Electrolysis of the Upper Trapezius plus Exercise

ACTIVE COMPARATOR

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

Device: Low-Intensity Percutaneous Electrolysis of the Upper Trapezius; Other: Upper Trapezius Stretching Exercise Program

High-Intensity Percutaneous Electrolysis of the Upper Trapezius plus Exercise

EXPERIMENTAL

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

Device: High-Intensity Percutaneous Electrolysis of the Upper Trapezius; Other: Upper Trapezius Stretching Exercise Program

Interventions

Low-Intensity Percutaneous Electrolysis of the Upper Trapezius 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.

Low-Intensity Percutaneous Electrolysis of the Upper Trapezius plus Exercise

High-Intensity Percutaneous Electrolysis of the Upper Trapezius 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.

High-Intensity Percutaneous Electrolysis of the Upper Trapezius plus Exercise

Upper Trapezius Stretching Exercise Program 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; Low-Intensity Percutaneous Electrolysis of the Upper Trapezius plus Exercise

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sivas State Hospital: lead

Study Sites (1)

Sivas Devlet Hastanesi

Sivas, Turkey (Türkiye)

RECRUITING

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: December 8, 2025
• First Posted: December 19, 2025
• Study Start: November 1, 2025
• Primary Completion: April 1, 2026
• Study Completion: April 10, 2026
• Last Updated: December 19, 2025

Record last verified: 2025-12

Locations

TU (1)