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临床试验/NCT07726823
NCT07726823招募中不适用

Comparative Effects of Mulligan Bent Leg Raise Versus Spinal Mobilization With Leg Movement on Pain, Neural Mobility, Balance and Functional Disability in Lumbar Radiculopathy

Riphah International University1 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2026年6月20日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
52
试验地点
1
主要终点
NPRS for pain

研究概览

简要总结

Lumbar radiculopathy is a spinal nerve root disorder often caused by lumbar disc herniation or compression, leading to radiating leg pain, restricted movement, and functional difficulties. This condition significantly disrupts daily activities and overall quality of life. While medication and exercise are common treatments, manual therapy techniques are gaining recognition for their non-invasive and effective outcomes in relieving symptoms and improving patient function.

详细描述

This randomized clinical trial will be conducted in Physiotherapy outpatient department of Jinnah Hospital Lahore. It will include 52 participants, aged 20 to 40 years, meeting clinical criteria for lumbar radiculopathy. Participants will be selected from an outpatient physiotherapy department and assigned randomly into two equal groups. Group A will receive the MBLR technique, while Group B will undergo the SMWLM technique. Both interventions will be applied three times a week for four weeks under standardized protocols. Key outcome measures include pain intensity assessed using the Numeric Pain Rating Scale (NPRS), neural mobility evaluated through the Straight Leg Raise (SLR) and Slump Test, and functional status measured using the Oswestry Disability Index (ODI), Timed Up and Go (TUG) test, and 5 Repetition Sit-to-Stand test for postural balance. Assessments will be conducted at baseline, after 2 weeks, at 4 weeks post-intervention, and at 8-week follow-up. Data analysis will be done by SPSS version 25. To ensure objectivity, all assessments will be conducted while keeping the patient unaware of their group assignment.

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)

入排标准

年龄范围
20 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Age 20 to 40 years (26)
  • Diagnosed patient with Unilateral Lumbar Radiculopathy secondary to L4/L5 and L5/S1 lumbar posterolateral disc buldge confirmed on MRI (12)
  • Posterolateral Lumbar Radiculopathy

排除标准

  • • Presence of red flags (e.g., cauda equina syndrome, severe neurological deficits).
  • Previous spinal surgery within 1 year.
  • Severe osteoporosis or vertebral fractures.
  • Pregnant women.
  • Systemic inflammatory or autoimmune diseases.

结局指标

主要结局

NPRS for pain

时间窗: upto 4 weeks

Pain intensity will be evaluated using the Numeric Pain Rating Scale, which ranges from 0 indicating "no pain" to 10 representing the "worst possible pain." It has shown excellent test-retest reliability, with intraclass correlation coefficients (ICC) ranging between 0.95 and 0.98 in individuals with musculoskeletal conditions

SLR and Slump test for neural mobility

时间窗: Upto 4 weeks

To assess neural mobility, the Straight Leg Raise and Slump Tests will be employed. These are well-established clinical tools for identifying lumbar nerve root irritation. The SLR test demonstrates strong diagnostic accuracy (\~81%) and excellent inter-rater reliability with kappa values above 0.90 and aprox 0.71 for slump test

Oswestry Disability Index test for functional outcome

时间窗: Upto 4 weeks

The ODI will be used to determine the level of functional disability associated with lower back pain. It includes 10 items that assess various aspects of daily activity. The tool has proven to be highly reliable (Cronbach's alpha = 0.87) and valid across different patient populations with lumbar spine conditions

Time up and go (TUG) test for functional outcome

时间窗: Upto 4 weeks

Balance and functional mobility will be measured using the TUG test, which involves timing a patient as they rise from a chair, walk three meters, turn, return, and sit down. This test is highly reliable (ICC = 0.82 to 0.99) and shows good concurrent validity in both spinal and geriatric populations (34). The cutoff value for balance and functional mobility TUG test is 7.2 sec

Five repetition sit to stand test

时间窗: upto 4 weeks

The 5 Rep Sit-to-Stand Test will be used to assess lower limb strength and functional performance. The patient gets to their maximum standing position and then sits back down five times as fast as they can without the use of their hands or arms. It has demonstrated excellent reliability (ICC \> 0.90) and shows strong correlation with functional ability (36). The cutoff value is \> 10 sec for 5 rep sitting to standing and standing to sitting transition

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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