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RecruitingNCT07294651Updated Dec 19, 2025

Percutaneous Electrolysis of the Upper Trapezius in Chronic Neck Pain

An interventional study of Low-Intensity Percutaneous Electrolysis of the Upper Trapezius and High-Intensity Percutaneous Electrolysis of the Upper Trapezius in Myofascial Pain of Upper Trapezius Muscle, sponsored by Sivas State Hospital. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-12-19.

Sponsored by Sivas State Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Apr 2026, 6 months ago, but the record still lists the study as recruiting.
  • Started Nov 2025; still recruiting 11 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Myofascial Pain of Upper Trapezius Muscle
03

In context

Lead sponsor

Sivas State Hospital is the lead sponsor of 5 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
40 participants (estimated)

Study arms

  • Active comparator
    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

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

  • Experimental
    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

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

Interventions

  • DeviceLow-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.

  • DeviceHigh-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.

  • OtherUpper Trapezius Stretching Exercise Program

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

06

What researchers measure

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.

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

Secondary outcomes

  1. Change in Pressure Pain Threshold (Algometry)

    Pressure will be applied with an algometer at a right angle to the point on the plantar fascia where tenderness is most pronounced, and the patient will be asked to indicate the level at which discomfort is felt. The pressure value at which pain occurs will be determined as the pain threshold, and the pressure-pain threshold will be objectively assessed and recorded. Measurements will be repeated three times, and the best value will be recorded.

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

  2. Change in Functional Disability (Modified Neck Disability Index)

    Functional disability related to neck pain will be assessed using the Modified Neck Disability Index (MNDI), a 10-item questionnaire evaluating pain intensity, personal care, lifting, reading, headaches, concentration, work, driving, sleeping, and recreation. Each item is scored from 0 to 5, yielding a total score between 0 and 50; higher scores indicate greater disability. The validated Turkish version of the scale will be used.

    Time frame: 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.

07

Study locations

1 of 1 sites recruiting
  • Sivas Devlet Hastanesi
    Sivas, Turkey (Türkiye)
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 19, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07294651
Lead sponsor
Sivas State Hospital
Responsible party
Serkan Polat (MD, Sivas State Hospital) — Principal investigator
First posted
Dec 19, 2025
Start date
Nov 1, 2025
Primary completion
Apr 1, 2026 (estimated)
Completion
Apr 10, 2026 (estimated)
Last update
Dec 19, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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