跳至主要内容
临床试验/NCT07750392
NCT07750392招募中不适用

The Role of Dry Needling Therapy and Low-Level Laser Microcurrent Electrical Stimulation on Serum Levels of Tumor Necrosis Factor-alpha (TNF-α) and Malondialdehyde (MDA) in Myofascial Pain Syndrome

Udayana University1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2026年7月30日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
80
试验地点
1
主要终点
Change in Serum Malondialdehyde (MDA) Concentration

研究概览

简要总结

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.

详细描述

Myofascial pain syndrome (MPS) is a common musculoskeletal pain disorder characterized by the presence of myofascial trigger points within skeletal muscle, resulting in localized and referred pain, reduced range of motion, and functional impairment. Acute upper trapezius MPS is associated with activation of inflammatory pathways and oxidative stress, including increased production of pro-inflammatory cytokines such as tumor necrosis factor-alpha (TNF-α) and lipid peroxidation products such as malondialdehyde (MDA). These biological processes contribute to peripheral sensitization and may play an important role in the development and persistence of pain.

Dry needling is a minimally invasive intervention that targets myofascial trigger points through insertion of a solid filiform needle to elicit mechanical and neurophysiological responses. Proposed mechanisms include normalization of dysfunctional motor end plates, improvement of local blood flow, reduction of inflammatory mediators, and modulation of peripheral nociceptive input. Low-Level Laser Microcurrent Electrical Stimulation (LL MCES) is a non-pharmacological modality that combines low-level laser therapy with microcurrent electrical stimulation to promote cellular repair, enhance adenosine triphosphate (ATP) production, improve tissue regeneration, and reduce inflammatory activity. Although both interventions have demonstrated clinical benefits in patients with MPS, evidence comparing their effects on systemic inflammatory and oxidative stress biomarkers remains limited.

This study is designed to investigate the biological mechanisms underlying the therapeutic effects of dry needling and LL MCES by evaluating changes in serum TNF-α and MDA concentrations following treatment. Clinical outcomes will be examined concurrently to explore whether biomarker modulation is associated with improvements in pain and functional disability. By integrating objective laboratory measures with patient-reported clinical outcomes, the study aims to provide insight into the pathophysiological mechanisms of treatment response in acute upper trapezius MPS.

The study will employ a prospective randomized controlled design involving adults with acute upper trapezius MPS. Participants will be allocated to one of four intervention groups: dry needling alone, LL MCES alone, combined dry needling and LL MCES, or sham dry needling. Serum TNF-α and MDA levels will be measured before and after the intervention, together with standardized assessments of pain intensity and neck-related disability. The findings are expected to clarify whether biomarker changes parallel clinical improvement and to provide evidence supporting mechanism-based, non-pharmacological management strategies for acute myofascial pain syndrome.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
None

入排标准

年龄范围
20 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

研究组 & 干预措施

Dry Needling Group

Experimental

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

干预措施: Dry Needle (Device)

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.

干预措施: Low-Level Laser Microcurrent Electrical Stimulation (Device)

Combined Dry Needling + LL MCES

Experimental

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

干预措施: Dry Needle (Device)

Combined Dry Needling + LL MCES

Experimental

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

干预措施: Low-Level Laser Microcurrent Electrical Stimulation (Device)

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.

干预措施: Sham Dry Needle (Device)

结局指标

主要结局

Change in Serum Malondialdehyde (MDA) Concentration

时间窗: Baseline and 3 days after completion of the intervention.

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.

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

时间窗: Baseline and 3 days after completion of the intervention.

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.

次要结局

未报告次要终点

研究者

发起方
Udayana University
申办方类型
Other
责任方
Principal Investigator
主要研究者

I Putu Eka Widyadharma, MD, MSc, PhD

Head of Neurology Study Program, Principal Investigator, Associate Professor

Udayana University

研究点 (1)

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