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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-45
SponsorUdayana University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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.

  • 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.

Treatment groups

80 Participants
are divided into 4 treatment groups
Group A: Dry Needling GroupExperimental treatment 1 intervention
Group B: Low-Level Laser Microcurrent Electrical Stimulation (LL MCES)Experimental treatment 1 intervention
Group C: Combined Dry Needling + LL MCESExperimental treatment 2 interventions
Group D: Sham Dry NeedlingSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline and 3 days after completion of the intervention.
2

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.

Time frame
Baseline and 3 days after completion of the intervention.

Secondary outcomes

Other outcomes

Sponsors and contacts

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