The Effectiveness of Pharmacopuncture With Platelet-Rich Plasma (PRP) as a Treatment for Chronic Neck Pain in Cervical Myofascial Syndrome Related to the Upper Trapezius Muscle
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Biomarker parameters
研究概览
简要总结
The goal of this clinical trial is to learn whether pharmacopuncture with Platelet-Rich Plasma (PRP) is effective for treating chronic neck pain in cervical myofascial syndrome related to the upper trapezius muscle. The main questions it aims to answer are:
- Is pharmacopuncture with Platelet-Rich Plasma (PRP) effective in reducing chronic neck pain in patients with cervical myofascial syndrome related to the upper trapezius muscle?
- Does PRP pharmacopuncture improve functional outcomes and quality of life in these patients?
- Are there any adverse effects associated with PRP pharmacopuncture in this context?
Researchers will compare PRP pharmacopuncture to normal saline pharmacopuncture (placebo) to evaluate whether PRP provides greater effectiveness in reducing chronic neck pain in cervical myofascial syndrome related to the upper trapezius muscle.
Participants will:
- Receive a single session of pharmacopuncture therapy
- Undergo evaluations at week 2, week 4, and week 8 after the intervention
详细描述
This is a clinical trial study to evaluate the effectiveness of PRP pharmacopuncture in patients with chronic neck pain in cervical myofascial syndrome related to the upper trapezius muscle. Participants are 60 males/females aged 18-59 years. They will be divided into two groups: (1) PRP pharmacopuncture and (2) Normal saline (placebo) pharmacopuncture. Each participant will receive a single pharmacopuncture treatment. Therapy efficacy will be assessed at week 2, week 4, and week 8 after the intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, aged 18 to 59 years.
- •Experiencing neck pain for more than 3 months (chronic).
- •Neck pain classified as Grade I to III according to the Neck Pain Task Force classification.
- •Presence of referred pain pattern on physical examination consistent with the distribution of the upper trapezius muscle.
- •Visual Analogue Scale (VAS) score between 30 and 70 mm (out of 100 mm) during activity (e.g., daily activities or light exercise).
- •Willing to participate in the study until completion and has signed the informed consent form.
排除标准
- •Hemoglobin level <13 g/dL for males or <12 g/dL for females.
- •Platelet count <150,000/μL.
- •Presence of fever (≥37.5°C).
- •Diagnosis of fibromyalgia.
- •Structural abnormalities of the cervical spine other than degenerative changes, such as fractures, cervical spine injuries, space-occupying lesions (SOL), infections, neoplasms, or systemic diseases confirmed by radiographic imaging.
- •History of cervical spine surgery.
- •Presence of tumors, wounds, or skin infections at the needle insertion site.
- •Diagnosed with blood disorders or currently taking anticoagulant or antiplatelet medications.
- •History of hypersensitivity reactions to acupuncture (e.g., metal allergy, severe atopy, keloids, or other skin hypersensitivities).
- •Uncontrolled cardiovascular disease or diabetes mellitus.
- •History of pharmacopuncture therapy to the upper trapezius muscle within the past 6 months.
- •Use of anti-inflammatory medication within the past 2 weeks.
- •Currently pregnant or breastfeeding.
研究组 & 干预措施
PRP Pharmacopuncture
Participants in the PRP pharmacopuncture arm will receive a single administration of platelet-rich plasma (PRP) via intramuscular injection at acupuncture points corresponding to chronic neck pain in cervical myofascial syndrome in the upper trapezius muscle.
干预措施: PRP Pharmacopuncture (Procedure)
Placebo Pharmacopuncture
Participants in the placebo pharmacopuncture arm will receive a single administration of normal saline via intramuscular injection at acupuncture points corresponding to chronic neck pain in cervical myofascial syndrome in the upper trapezius muscle.
干预措施: Placebo Pharmacopuncture (Procedure)
结局指标
主要结局
Biomarker parameters
时间窗: before treatment (baseline) and 4 weeks after treatment
The serum concentration of interleukin-1 beta (IL-1β) and vascular endothelial growth factor (VEGF) will be measured as outcome biomarkers to evaluate inflammatory and angiogenic responses following the intervention.
次要结局
- Visual Analogue Scale(before treatment (baseline), 2 weeks, 4 weeks, and 8 weeks after treatment)
- Pressure Pain Threshold(before treatment (baseline), 2 weeks, 4 weeks, and 8 weeks after treatment)
- Neck Disability Index(before treatment (baseline), 2 weeks, 4 weeks, and 8 weeks after treatment)
- Perceived Stress Scale(before treatment (baseline), 2 weeks, 4 weeks, and 8 weeks after treatment)
- Pain Catastrophizing Scale(before treatment (baseline), 2 weeks, 4 weeks, and 8 weeks after treatment)
- Short-Form 12 Health Survey(before treatment (baseline), 2 weeks, 4 weeks, and 8 weeks after treatment)
- Cervical Range of Motion(before treatment (baseline), 2 weeks, 4 weeks, and 8 weeks after treatment)
- Craniovertebral Angle(before treatment (baseline), 2 weeks, 4 weeks, and 8 weeks after treatment)
- Size of Myofascial Trigger Point Nodules(before treatment (baseline), 2 weeks, 4 weeks, and 8 weeks after treatment)
- Resistive Index(before treatment (baseline), 2 weeks, 4 weeks, and 8 weeks after treatment)
研究者
Irma Nareswari, MD
Principal Investigator
Indonesia University