Effectiveness of Mechanical Diagnosis and Therapy 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 VAS and PPTs
研究概览
简要总结
This randomized controlled trial aims to evaluate the effectiveness of Mechanical Diagnosis and Therapy also known as McKenzie exercises compared to conventional physiotherapy in patients with L5 S1 lumbar disc herniation. The primary purpose is to investigate whether McKenzie exercises significantly improve disc morphology, neurophysiological parameters, pain intensity, and functional status compared to conventional physiotherapy interventions. The hypothesis is that McKenzie exercises will result in superior clinical outcomes including improved disc morphology and neurophysiology reduced pain intensity and enhanced functional ability relative to conventional physiotherapy treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and 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.
- •Not currently recommended for surgery or prefers non-surgical treatment.
- •Provides written informed consent to participate.
排除标准
- •Patients diagnosed with calcified or hard disc herniation confirmed by MRI.
- •Symptoms indicating Cauda Equina Syndrome (e.g., urinary retention, saddle anaesthesia).
- •Presence of other spinal pathologies such as tumors, infections (e.g., tuberculosis), or vertebral fractures.
- •History of previous lumbar spine surgery at the affected level (L5/S1).
- •Participants with uncontrolled diabetes mellitus.
- •Pregnant women or those planning pregnancy during the study period.
- •Participants with medical contraindications to exercise, including bleeding disorders, active anticoagulant therapy (excluding low-dose aspirin), and severe cardiovascular or neuromuscular conditions.
结局指标
主要结局
1. Pain by VAS and PPTs
时间窗: 4 weeks
2. Disc Morphology by disc height, disc echogenicity, and disc displacement (assessed via MSK-USG)
时间窗: 4 weeks
3. Neurological Recovery by SLR, NCS, and EMG
时间窗: 4 weeks
次要结局
- Disability by Oswestry Disability Index (ODI)(Baseline, 1 month, 3 months, and 6 months post-intervention)
研究者
Mahmudul Haque Udoy
Jashore University of Science and Technology