THE ROLE OF DRY NEEDLING THERAPY AND LOW-LEVEL LASER MICROCURRENT ELECTRICAL STIMULATION ON SERUM LEVELS OF TNF-α AND MALONDIALDEHYDE IN MYOFACIAL PAIN SYNDROME

NCT07750392 | Recruiting FDA Device

• 1 other identifier: 2632/UN14.2.2.VII.14/LT/2026
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

myofascial; dry needling; laser; tnf-alpha; Malondialdehyde

Outcome Measures

Primary Outcomes (2)

• Change in Serum Malondialdehyde (MDA) Concentration

  Change in serum malondialdehyde (MDA) concentration from baseline to post-intervention measured using ELISA. Results will be expressed in nmol/mL. A greater reduction indicates improvement in oxidative stress.

  Baseline and 3 days after completion of the intervention.

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

  Change in serum TNF-α concentration from baseline to post-intervention measured using enzyme-linked immunosorbent assay (ELISA). Results will be expressed in pg/mL. A greater reduction indicates improvement in systemic inflammatory activity.

  Baseline and 3 days after completion of the intervention.

Study Arms (4)

Dry Needling Group

EXPERIMENTAL

Participants receive dry needling treatment targeting active myofascial trigger points in the upper trapezius muscle according to the study protocol.

Device: Dry Needle

Low-Level Laser Microcurrent Electrical Stimulation (LL MCES)

EXPERIMENTAL

Participants receive LL MCES therapy applied to the upper trapezius trigger point region according to the study protocol.

Device: Low-Level Laser Microcurrent Electrical Stimulation

Combined Dry Needling + LL MCES

EXPERIMENTAL

Participants receive both dry needling and LL MCES during the same treatment session according to the study protocol.

Device: Dry Needle; Device: Low-Level Laser Microcurrent Electrical Stimulation

Sham Dry Needling

SHAM COMPARATOR

Participants receive a sham dry needling procedure designed to mimic the treatment experience without therapeutic needle penetration of the trigger point.

Device: Sham Dry Needle

Interventions

Dry Needle DEVICE

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.

Combined Dry Needling + LL MCES; Dry Needling Group

Low-Level Laser Microcurrent Electrical Stimulation DEVICE

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.

Combined Dry Needling + LL MCES; Low-Level Laser Microcurrent Electrical Stimulation (LL MCES)

Sham Dry Needle DEVICE

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.

Sham Dry Needling

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Participants must meet all of the following criteria:
• Adults aged 18 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.

You may not qualify if:

• 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 disorders, anticoagulant therapy, or other contraindications to needling.
• Pregnancy or breastfeeding. Active malignancy, autoimmune disease, uncontrolled diabetes mellitus, acute infection, or other systemic inflammatory conditions.
• History of severe psychiatric illness or inability to complete study assessments.
• Participation in another interventional clinical trial within the previous 30 days.

Sponsors & Collaborators

• Udayana University: lead

Study Sites (1)

Udayana University

Denpasar, Bali, Indonesia

RECRUITING

MeSH Terms

Conditions

Facial Neuralgia

Condition Hierarchy (Ancestors)

Facial Nerve Diseases; Mouth Diseases; Stomatognathic Diseases; Cranial Nerve Diseases; Nervous System Diseases

Central Study Contacts

I Putu Eka Widyadharma, MD, PhD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: August 2, 2026
• First Posted: August 6, 2026
• Study Start: July 30, 2026
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): February 28, 2027
• Last Updated: August 6, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)