Randomized, Parallel-Group, Superiority Trial of Mirror Image Spine Correction Exercises Versus Conservative Physiotherapy for Lumbar Nerve Root Microstructural Integrity Assessed by Diffusion Tensor Imaging in Adults With Lumbar Radiculopathy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Lumbar Nerve Root Fractional Anisotropy
研究概览
简要总结
Lumbar radiculopathy is a common condition caused by irritation or compression of a lumbar nerve root, often resulting in radiating leg pain, numbness, weakness, and functional limitation. Conservative physiotherapy is commonly used as first-line treatment, but outcomes vary among patients.
This randomized controlled trial will compare Mirror Image Spine Correction Exercises with standardized conservative physiotherapy in adults with lumbar radiculopathy. Participants will be randomly assigned to one of two treatment groups for 12 weeks.
The primary outcome is lumbar nerve root microstructural integrity measured using Diffusion Tensor Imaging (DTI), including Fractional Anisotropy and other diffusion parameters. Secondary outcomes include pain intensity, disability, spinal alignment, and adverse events.
The purpose of this study is to determine whether a targeted posture-correction exercise approach provides greater improvement than conventional physiotherapy.
详细描述
Lumbar radiculopathy is a neuromusculoskeletal disorder commonly caused by lumbar disc herniation or foraminal stenosis leading to nerve root irritation or compression. Symptoms commonly include radiating leg pain, paresthesia, weakness, altered reflexes, and reduced physical function.
Conservative physiotherapy is recommended as first-line management and may include education, graded exercise, mobility restoration, strengthening, neural mobilization, and symptom management. However, treatment response is heterogeneous, and many patients continue to experience persistent symptoms.
Most previous rehabilitation studies have relied primarily on patient-reported outcomes such as pain and disability. These measures are clinically important but may not fully reflect biological recovery of the affected nerve root.
Diffusion Tensor Imaging (DTI) is an advanced magnetic resonance imaging technique that can quantify neural tissue microstructure. Parameters such as Fractional Anisotropy (FA), Mean Diffusivity (MD), Axial Diffusivity (AD), and Radial Diffusivity (RD) may provide objective markers of nerve recovery.
Mirror Image Spine Correction Exercises are individualized posture-based exercises designed to move the trunk or pelvis opposite to identified alignment deviations. This approach may improve biomechanics, reduce abnormal loading, and decrease neural irritation.
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
Outcome assessors and imaging analysts will be blinded to group allocation where feasible. Participants and treating physiotherapists cannot be blinded due to the nature of exercise interventions.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18 years or older. Clinical diagnosis of unilateral lumbar radiculopathy. Presence of at least two of the following: dermatomal radiating leg pain, neurological deficit, positive neural tension test.
- •MRI-confirmed lumbar nerve root compression or irritation consistent with symptoms.
- •Pain intensity of 3/10 or greater. Able to undergo MRI and Diffusion Tensor Imaging (DTI). Able to understand study procedures and provide written informed consent.
排除标准
- •Previous lumbar spine surgery. Bilateral radiculopathy or unclear diagnosis. Tumor, infection, fracture, inflammatory spinal disease, or cauda equina syndrome.
- •Severe progressive neurological deficit requiring urgent treatment. Contraindications to MRI (pacemaker, incompatible implants, severe claustrophobia).
- •Recent lumbar injections or surgery. Other neurological or musculoskeletal disorders affecting outcomes. Pregnancy if MRI contraindicated by local policy. Cognitive impairment or inability to follow instructions.
研究组 & 干预措施
Mirror Image Spine Correction Exercises
Participants will receive a supervised individualized Mirror Image Spine Correction Exercise program three sessions per week for 12 weeks. Exercises will be based on postural alignment findings and include a prescribed home exercise program.
干预措施: Mirror Image Spine Correction Exercises (Behavioral)
Conservative Physiotherapy
Participants will receive standardized conservative physiotherapy three sessions per week for 12 weeks including education, graded exercise, mobility training, strengthening, and clinically indicated adjunctive techniques.
干预措施: Conservative Physiotherapy (Behavioral)
结局指标
主要结局
Lumbar Nerve Root Fractional Anisotropy
时间窗: Baseline and Week 12
Change in lumbar nerve root microstructural integrity measured using Diffusion Tensor Imaging (DTI) Fractional Anisotropy.
次要结局
- Pain Intensity(Baseline and Week 12)
- Spinal Alignment(Baseline and Week 12)
- Additional DTI Parameters(Baseline and Week 12)
研究者
Fatima Alowais
Associate Professor, Department of Physiotherapy, Principal Investigator
University of Sharjah