Dry Needling and Low-Level Laser Microcurrent Electrical Stimulation for Myofascial Pain Syndrome
Recruiting · NCT07750392 · Interventional (participants receive a specific treatment) · Lead sponsor: Udayana University
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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 take part
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 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.
Where it is running
1 location listed.
- Udayana University - Denpasar, Bali, Indonesia