Myofascial Pain of Upper Trapezius MuscleNCT07294651
Percutaneous Electrolysis of the Upper Trapezius in Chronic Neck Pain
A study testing Low-Intensity Percutaneous Electrolysis of the Upper Trapezius, High-Intensity Percutaneous Electrolysis of the Upper Trapezius and Upper Trapezius Stretching Exercise Program in people with Myofascial Pain of Upper Trapezius Muscle, run by Sivas State Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Myofascial Pain of Upper Trapezius Muscle
- What is being tested?
- Low-Intensity Percutaneous Electrolysis of the Upper Trapezius, High-Intensity Percutaneous Electrolysis of the Upper Trapezius and Upper Trapezius Stretching Exercise Program
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2025to 10 Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Sivas Devlet Hastanesi
Sivas
Serkan Polat, MD, +9555555555, dr.serkan.0505@gmail.com
About this study
Official title: Effectiveness of Different Percutaneous Electrolysis Treatment Protocols Targeting the Upper Trapezius Muscle in Chronic Neck Pain: A Randomized Controlled Trial
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.
- Being tested
- Low-Intensity Percutaneous Electrolysis of the Upper Trapezius, High-Intensity Percutaneous Electrolysis of the Upper Trapezius, Upper Trapezius Stretching Exercise Program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-Intensity Percutaneous Electrolysis of the Upper TrapeziusDevice
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.
High-Intensity Percutaneous Electrolysis of the Upper TrapeziusDevice
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 ProgramOther
Home-based stretching exercise program targeting the upper trapezius muscle throughout the treatment period in both groups.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Device: High-Intensity Percutaneous Electrolysis of the Upper Trapezius; Other: Upper Trapezius Stretching Exercise Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
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.
Measured: Baseline, post-treatment (approximately 2 weeks), and 3 months after treatment initiation.
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2025
- Study start1 Nov 2025
- Primary completion1 Apr 2026 (estimated)
- Study completion10 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myofascial Pain of Upper Trapezius MuscleStudies 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
- 40 participants (estimated)
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
- NCT07294651
- Sponsor's protocol ID
- EPTE-MAS-001-S
- Status last verified
- Dec 2025
- First submitted
- 8 Dec 2025
- Last updated
- 19 Dec 2025
- 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 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Different Percutaneous Electrolysis Treatment Protocols Targeting the Upper Trapezius Muscle in Chronic Neck Pain: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07294651
- Acronym / sponsor ID
- EPTE-MAS-001-S
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Sivas State HospitalUniversity, hospital or other
- Study start
- 1 Nov 2025 (actual)
- Primary completion
- 1 Apr 2026 (estimated)
- Study completion
- 10 Apr 2026 (estimated)
- First posted
- 19 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low-Intensity Percutaneous Electrolysis of the Upper Trapezius plus Exercise | Active comparator | Device: Low-Intensity Percutaneous Electrolysis of the Upper Trapezius, Other: Upper Trapezius Stretching Exercise ProgramParticipants 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 |
| High-Intensity Percutaneous Electrolysis of the Upper Trapezius plus Exercise | Experimental | Device: High-Intensity Percutaneous Electrolysis of the Upper Trapezius, Other: Upper Trapezius Stretching Exercise ProgramParticipants 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 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
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 |
|---|---|---|
| Low-Intensity Percutaneous Electrolysis of the Upper TrapeziusUltrasound-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. | Device | Low-Intensity Percutaneous Electrolysis of the Upper Trapezius plus Exercise |
| High-Intensity Percutaneous Electrolysis of the Upper TrapeziusUltrasound-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. | Device | High-Intensity Percutaneous Electrolysis of the Upper Trapezius plus Exercise |
| Upper Trapezius Stretching Exercise ProgramHome-based stretching exercise program targeting the upper trapezius muscle throughout the treatment period in both groups. | Other | High-Intensity Percutaneous Electrolysis of the Upper Trapezius plus Exercise, Low-Intensity Percutaneous Electrolysis of the Upper Trapezius plus Exercise |
Primary outcome
Change in Pain Intensity (VAS)
Time frame: Baseline (before treatment), immediately after completion of the 3rd treatment session (approximately 2 weeks), and 3 months after treatment initiation.
Pain intensity related to plantar heel pain will be assessed using a 10-cm Visual Analog Scale (VAS). Higher scores indicate greater pain.
2 secondary outcomes
Change in Pressure Pain Threshold (Algometry)
Time frame: Baseline, post-treatment (approximately 2 weeks), and 3 months after treatment initiation.
Change in Functional Disability (Modified Neck Disability Index)
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2025.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low-Intensity Percutaneous Electrolysis of the Upper Trapezius, High-Intensity Percutaneous Electrolysis of the Upper Trapezius and Upper Trapezius Stretching Exercise Program in people with Myofascial Pain of Upper Trapezius Muscle, 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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 19 Dec 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pain Intensity (VAS) (time frame: Baseline (before treatment), immediately after completion of the 3rd treatment session (approximately 2 weeks), and 3 months after treatment initiation.). 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 19 Dec 2025.