Effects of Neural Mobilization Combined With Manual Therapy on Functional Outcomes and Exploratory Infrared Thermographic Changes in Patients With Lumbar Disc Herniation: A Randomized Sham-Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Change in Oswestry Disability Index (ODI) Score
研究概览
简要总结
The objective of this randomized controlled clinical trial is to evaluate whether manual therapy combined with neural mobilization can improve pain, functional impairment, quality of life, inflammatory markers, and infrared thermographic findings in patients with lumbar disc herniation. The study subjects consist of 72 patients with lumbar disc herniation (aged 18-65 years, with unilateral lumbar radicular symptoms).
The primary questions it aims to address are:
- In patients with lumbar disc herniation, is manual therapy combined with neural mobilization more effective than manual therapy alone in relieving pain and improving functional impairment?
- Can manual therapy combined with neural mobilization improve patients' quality of life, inflammation-related markers (IL-6 and TNF-α), and body temperature changes detected by infrared thermography?
The researchers compared:
- Experimental group: manual therapy combined with neural mobilization (36 cases)
- Control group: manual therapy with sham neural mobilization (36 cases)
to determine whether adding neural mobilization can provide additional therapeutic effects, including better pain relief, functional recovery, and improvement in related physiological indicators.
Participants will:
- Receive a 3-week course of treatment, totaling approximately 11 sessions.
- Undergo standardized manual therapy, including lumbar mobilization and soft tissue therapy, to help relieve pain and improve mobility.
- Receive additional treatment according to group assignment:
- The experimental group will receive sciatic nerve mobilization through gentle, controlled leg movements to improve nerve function and reduce nerve sensitivity.
- The control group will receive lumbar traction therapy to relieve lumbar stress.
- Be assessed before and after treatment, including pain scores, functional impairment scores (ODI), quality of life surveys (SF-12), infrared thermography examinations, and blood tests for inflammatory markers.
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 65 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants will be eligible for inclusion if they meet the following criteria:
- •Adults aged 18-65 years. Diagnosis of lumbar disc herniation based on clinical symptoms and imaging findings.
- •Presence of unilateral lumbar radiculopathy. Persistent symptoms despite initial conservative management. Ability to participate in the intervention protocol. Provided written informed consent before study enrollment.
排除标准
- •Participants will be excluded if they meet any of the following criteria:
- •Requirement for surgical intervention for lumbar disc herniation. Serious spinal conditions, including spinal infection, tumor, or fracture. Severe systemic diseases or acute inflammatory conditions. Pregnancy or breastfeeding. Receipt of other interventions that may affect study outcomes during the study period.
研究组 & 干预措施
Arm 1
Manual Therapy + Neural Mobilization
干预措施: Neural Mobilization (Behavioral)
Arm 1
Manual Therapy + Neural Mobilization
干预措施: Manual Therapy (Behavioral)
Arm 2
Manual Therapy + Sham Neural Mobilization
干预措施: Sham Neural Mobilization (Behavioral)
Arm 2
Manual Therapy + Sham Neural Mobilization
干预措施: Manual Therapy (Behavioral)
结局指标
主要结局
Change in Oswestry Disability Index (ODI) Score
时间窗: Baseline and Week 3 (end of intervention)
次要结局
- Change in Pain Intensity Measured by Visual Analog Scale (VAS)(Baseline and Week 3 (end of intervention))
- Health-related quality of life (SF-12)(Baseline and Week 3)
- Change in Infrared Thermographic Temperature Parameters(Baseline, Week 1, and Week 3)
- Change in Serum Inflammatory Biomarkers (IL-6 and TNF-α)(Baseline and Week 3)
研究者
Jiaqi Shi
Orthopedic Physical Therapist
Longhua Hospital
