Efficacy of Shacklock Neural Mobilization vs. McKenzie Extension Principle in Lumbar Radiculopathy: A Randomized Comparative Trial on Pain and Functional Disability
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 59
- 试验地点
- 2
- 主要终点
- Pain Intensity
研究概览
简要总结
This randomized comparative trial evaluates the efficacy of Shacklock neural mobilization versus the McKenzie extension principle in patients with lumbar radiculopathy. The study aims to compare both interventions in terms of their effectiveness in reducing pain and improving functional disability. Outcomes will be measured using validated tools such as the Visual Analog Scale (VAS) for pain and the Oswestry Disability Index (ODI). The trial seeks to inform evidence-based physiotherapeutic approaches for managing lumbar radiculopathy.
详细描述
This randomized comparative trial is designed to assess and compare the efficacy of Shacklock Neural Mobilization (SNM) and the McKenzie Extension Principle (MEP) in the management of lumbar radiculopathy. Lumbar radiculopathy is commonly associated with nerve root compression, resulting in significant pain and functional limitations. While SNM focuses on restoring normal neurodynamic mobility and reducing mechanosensitivity of the nervous system, MEP targets spinal mechanical derangements through repeated extension movements. Despite their widespread clinical use, direct comparative evidence on their effectiveness remains limited.
The study utilizes a two-arm, parallel-group design with repeated measures. Participants diagnosed with lumbar radiculopathy were randomly assigned to one of two intervention groups: the SNM group or the MEP group. Each group received their respective intervention over a structured three-week treatment period.
Interventions were administered by qualified physiotherapists following standardized protocols. Pain intensity and functional disability were measured using the Visual Analog Scale (VAS) and the Oswestry Disability Index (ODI), respectively. Assessments were conducted at baseline and weekly thereafter until the end of the intervention period.
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
- 25 Years 至 38 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •It required participants to have subacute lumbar radiculopathy (3-6 months duration) with radiating pain to or beyond the knee, with or without neurological signs, and MRI-confirmed mild disc bulge. Eligibility also required meeting at least three of four standardized test item cluster criteria and the ability to read and understand English.
排除标准
- •It included a history of spinal trauma or surgery, presence of systemic diseases (such as rheumatoid arthritis or diabetes), severe disc pathology (e.g., sequestration), spinal deformities (e.g., scoliosis >10°), chronic radiculopathy lasting more than one year, or current use of nonsteroidal anti-inflammatory drugs (NSAIDs).
结局指标
主要结局
Pain Intensity
时间窗: 3 weeks
Pain intensity was measured using the Visual Analog Scale (VAS), a 10-cm horizontal line anchored by no pain (0) and worst imaginable pain. The VAS is a validated and reliable tool, with excellent test-retest reliability (ICC = 0.94) and strong correlations with other pain measures. Patients marked their pain after a 10-minute rest to minimize activity-induced fluctuations, and assessments were conducted at standardized time points throughout the intervention period.
Functional Disability
时间窗: 3 weeks
The Oswestry Disability Index (ODI) version 2.1a was used to assess functional limitations related to lumbar radiculopathy. This 10-item questionnaire, scored from 0 to 100%, has demonstrated excellent internal consistency (α = 0.90) and test-retest reliability (ICC = 0.91) in lumbar spine conditions. Participants completed the ODI independently under standardized conditions, ensuring accurate assessment of daily activity limitations associated with radiculopathy.
Lumbar Range of Motion
时间窗: 3 weeks
Spinal mobility was objectively assessed using a modified Schober's test combined with digital inclinometry (Baseline® inclinometer). Flexion was measured using Schober's method, while extension was assessed with the inclinometer placed at the T12-L1 level. Three consecutive readings were taken and averaged for each direction following a standardized warm-up protocol to minimize viscoelastic tissue effects and ensure consistency across assessments.
Neurodynamic Assessment
时间窗: 3 weeks
The Straight Leg Raise (SLR) test was conducted using a standardized protocol known for high sensitivity in detecting nerve root compression when combined with ankle dorsiflexion. A Baseline® 12 plastic goniometer was used to measure the angle at which radicular symptoms were first reproduced. The hip was moved at a controlled rate of 10 degree, second to differentiate neural from musculoskeletal responses. This approach allows for consistent and reliable monitoring of neurodynamic changes throughout the intervention period.
次要结局
未报告次要终点
研究者
AMIR IQBAL
Principal Investigator
King Saud University