RecruitingNot Applicable

Dry Needling and Low-Level Laser Microcurrent Electrical Stimulation for Myofascial Pain Syndrome

Indonesia80 participantsStarted 2026-07-30

Plain-language summary

This study aims to evaluate the effectiveness of dry needling and Low-Level Laser Microcurrent Electrical Stimulation (LL MCES) in patients with acute upper trapezius myofascial pain syndrome (MPS) by assessing both biological and clinical outcomes. Specifically, it investigates whether these interventions reduce serum levels of the inflammatory biomarker tumor necrosis factor-alpha (TNF-α) and the oxidative stress biomarker malondialdehyde (MDA), while also improving pain intensity and neck-related disability. The study seeks to address the current knowledge gap regarding the relationship between changes in inflammatory and oxidative stress biomarkers and clinical improvement following these non-pharmacological treatments. The primary research question is: Do dry needling and LL MCES reduce serum TNF-α and MDA levels and improve clinical outcomes in patients with acute upper trapezius myofascial pain syndrome? Participants will: Be randomly assigned to receive dry needling, LL MCES, combined dry needling and LL MCES, or sham dry needling. Receive treatment according to the assigned intervention protocol. Undergo blood sampling before and after the intervention to measure serum TNF-α and MDA levels. Complete assessments of pain intensity using the Numerical Pain Rating Scale (NPRS) and neck-related disability using the Neck Disability Index (NDI) before and after treatment. Attend scheduled follow-up visits for clinical evaluation and outcome assessment.

Who can participate

Age range

20 Years – 45 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Participants must meet all of the following criteria: Adults aged 20 to 45 years. Clinical diagnosis of acute upper trapezius myofascial pain syndrome (MPS) with symptom duration of less than 1 month. Presence of at least one active myofascial trigger point in the upper trapezius muscle confirmed by physical examination according to accepted diagnostic criteria (palpable taut band, hypersensitive trigger point, reproduction of the patient's typical pain, and/or local twitch response). Moderate or greater neck pain (Numerical Pain Rating Scale \[NPRS\] ≥4). Willing and able to provide written informed consent and comply with study procedures. Exclusion Criteria: * Participants meeting any of the following criteria will be excluded: Previous dry needling or LL MCES treatment for the current episode of myofascial pain. Chronic myofascial pain syndrome (symptom duration ≥1 month). Current use of systemic corticosteroids, nonsteroidal anti-inflammatory drugs (NSAIDs), or other medications that may significantly influence inflammatory biomarkers within the washout period specified in the protocol. Previous surgery, fracture, or significant trauma involving the neck or shoulder region. Cervical radiculopathy, cervical myelopathy, fibromyalgia, inflammatory arthritis, or other neurological or musculoskeletal disorders that could explain the symptoms. Local skin infection, open wound, or other contraindications to dry needling or LL MCES. Bleeding dis…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Serum Malondialdehyde (MDA) Concentration

Timeframe: Baseline and 3 days after completion of the intervention.

Change in Serum Tumor Necrosis Factor-Alpha (TNF-α) Concentration

Timeframe: Baseline and 3 days after completion of the intervention.

Trial details

NCT IDNCT07750392

SponsorUdayana University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-11-30

Contact for this trial

I Putu Eka Widyadharma, MD, PhD

+62 812-3787-2840 eka.widyadharma@unud.ac.id

View on ClinicalTrials.gov More Myofacial Pain Syndrome trials