Effectiveness of Ultrasound-Guided Platelet-Rich Plasma Combined with Physiotherapy on Disc Morphology and Neurophysiology in L5/S1 Lumbar Disc Herniation
试验速览
- 阶段
- 不适用
- 状态
- Not Applicable
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- 1. Pain by NPRS and PPTs
研究概览
简要总结
This randomized controlled trial aims to evaluate the effectiveness of ultrasound-guided platelet-rich plasma (PRP) injection combined with McKenzie exercises compared to McKenzie exercises alone in patients with MRI-confirmed L5/S1 lumbar disc herniation. The study will assess improvements in pain, disc morphology, neurological recovery, and functional disability. Sixty patients will be enrolled and allocated into two groups. The hypothesis is that the combined approach of PRP and physiotherapy will produce superior outcomes in terms of structural and neurophysiological recovery compared to physiotherapy alone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 25.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- All
入选标准
- •Adults aged 25 to 55 years, both sexes.
- •Clinically diagnosed L5 to S1 lumbar disc herniation confirmed by MRI (disc protrusion or bulge, with or without nerve root compression).
- •Chronic low back pain with or without radiating leg pain, consistent with radiculopathy, for more than 6 weeks.
- •Pain intensity of 3 or above on the Visual Analogue Scale (VAS).
- •Inadequate response to prior conservative treatments (e.g., rest, oral medication, or physiotherapy without supervision).
- •Positive Straight Leg Raise test or neurological signs such as sensory change, weakness, or altered reflex.
- •Platelet count within the normal range (150,000 to 400,000 per microliter).
- •Provides written informed consent to participate.
排除标准
- •Calcified disc herniation or hard disc on imaging
- •Cauda equina syndrome (e.g., urinary retention, saddle anesthesia)
- •Other spinal pathologies, including tumors, spinal infections (e.g., tuberculosis), or vertebral fractures
- •Previous lumbar spine surgery at the affected level
- •Uncontrolled diabetes mellitus
- •Pregnancy
- •Contraindications to PRP or exercises: Bleeding disorders (e.g., haemophilia), Current anticoagulant use (except low-dose aspirin), Severe cardiovascular or neuromuscular comorbidities).
结局指标
主要结局
1. Pain by NPRS and PPTs
时间窗: Baseline, 1 month, 3 months, and 6 months post-intervention
2. Disc Morphology by disc height, disc echogenicity, and disc displacement (assessed via MSK-USG)
时间窗: Baseline, 1 month, 3 months, and 6 months post-intervention
3. Neurological Recovery by SLR, NCS, and EMG
时间窗: Baseline, 1 month, 3 months, and 6 months post-intervention
次要结局
- Disability by Oswestry Disability Index (ODI)(Baseline, 1 month, 3 months, and 6 months post-intervention)
研究者
Rayhan Islam
Jashore University of Science and Technology