Ultrasound-Guided Dry Needling, Lidocaine Injection, and Oxygen-Ozone Therapy for Myofascial Pain Syndrome: Clinical and Ultrasonographic Outcomes of a Prospective Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- Pain Intensity (Visual Analog Scale, VAS)
研究概览
简要总结
Prospective, assessor-blinded, randomized controlled trial comparing ultrasound-guided dry needling, lidocaine injection, and oxygen-ozone injection in patients with myofascial pain syndrome (MPS) of the upper trapezius muscle. 76 participants received weekly injections/needling for 3 sessions plus a standardized home exercise program, with clinical (pain, function, sleep, quality of life) and ultrasonographic (tissue imaging, blood flow waveform) outcomes assessed at baseline, Week 4, and Week 12.
详细描述
Design: Prospective, assessor-blinded RCT Randomization: Computer-generated block randomization (block size = 6), sequentially numbered opaque sealed envelopes Blinding: Single-blind (outcome assessors blinded); participant blinding not feasible due to nature of interventions All procedures performed by a single physiatrist (>10 years experience), ultrasound-guided, aseptic technique
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
- Single (Outcomes Assessor)
盲法说明
This was a single-blind study in which outcome assessors were blinded to group allocation. Due to the nature of the interventions (dry needling, lidocaine injection, and oxygen-ozone injection), blinding of participants and treating clinicians was not feasible. However, all clinical evaluations and statistical analyses were conducted by investigators who were unaware of treatment assignment, in order to minimize assessment and analysis bias
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 65 years
- •Neck pain of at least 3 months' duration
- •Diagnosis of myofascial pain syndrome (MPS) according to the Simons and Travell criteria
- •At least one active trigger point and/or palpable taut band within the upper trapezius muscle
- •Reproduction of typical pain upon digital compression of the trigger point
排除标准
- •Cervical radiculopathy or myelopathy
- •Advanced degenerative cervical spine disease
- •History of neck trauma or surgery within the previous year
- •Prior injection into the trapezius muscle within the last 3 months
- •Systemic conditions, including fibromyalgia, rheumatoid arthritis, polyneuropathy, coagulopathy, malignant hypertension, Graves' disease, or severe thrombocytopenia (platelet count <50,000/µL)
- •Cognitive impairment
- •Pregnancy
结局指标
主要结局
Pain Intensity (Visual Analog Scale, VAS)
时间窗: Baseline, Week 4, and Week 12
"Pain intensity was assessed using the Visual Analog Scale (VAS), ranging from 0 (no pain) to 10 (worst imaginable pain)."
次要结局
- Neck Disability Index (NDI)(Baseline, Week 4, and Week 12)
- Pittsburgh Sleep Quality Index (PSQI)(Baseline, Week 4, and Week 12)
- Short Form-36 (SF-36)(Baseline, Week 4, and Week 12)
- Tissue Imaging Score (TIS)(Baseline, Week 4, and Week 12)
- Blood Flow Waveform Score (BFS)(Baseline, Week 4, and Week 12)
研究者
İlhan Celil Özbek
MD
Derince Training and Research Hospital