Dry Needling and Low-Level Laser Microcurrent Electrical Stimulation for Myofascial Pain Syndrome
NCT07750392 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80
Last updated 2026-08-10
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.
Conditions
- Myofacial Pain Syndrome
Interventions
- DEVICE
-
Dry Needle
Dry needling is performed using a sterile disposable filiform needle inserted into identified active trigger points of the upper trapezius muscle. The needle is manipulated to elicit a local twitch response when possible, and the procedure is conducted by a trained physician following a standardized treatment protocol.
- DEVICE
-
Low-Level Laser Microcurrent Electrical Stimulation
Low-Level Laser Microcurrent Electrical Stimulation (LL MCES) LL MCES is delivered using a therapeutic device that combines low-level laser irradiation and microcurrent electrical stimulation. Treatment parameters, application sites, and duration are standardized across participants.
- DEVICE
-
Sham Dry Needle
A validated sham needling technique is used in which the procedure simulates dry needling while avoiding therapeutic penetration of the myofascial trigger point. The duration and treatment setting are matched to the active dry needling intervention.
Sponsors & Collaborators
-
Udayana University
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- BASIC_SCIENCE
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 20 Years
- Max Age
- 45 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-07-30
- Primary Completion
- 2026-11-30
- Completion
- 2027-02-28
- FDA Device
- Yes
Countries
- Indonesia
Study Locations
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