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临床试验/CTRI/2025/02/081035
CTRI/2025/02/081035已完成不适用

comparison of contralateral and ipsilateral slider neural mobilization with blood flow restriction training in unilateral lumbar radiculopathy- a randomized clinical trial

Somesh Rajesh Takkekar1 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2025年3月4日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
38
试验地点
1
主要终点
Numeric pain rating scale (NPRS)

研究概览

简要总结

COMPARISON OF CONTRALATERAL VERSUS IPSILATERAL SLIDER NEURAL MOBILISATION WITH BLOOD FLOW RESTRICTION TRAINING IN UNILATERAL LUMBAR RADICULOPATHY - A RANDOMISED CLINICAL TRIAL

AIM: To evaluate and compare the immediate effect contralateral versus ipsilateral neural slider mobilization with blood flow restriction training on lower extremity pain and hip range of motion (ROM) in unilateral lumbar radiculopathy.

•OBJECTIVE:

ØTo determine the immediate effect of contralateral neural slider mobilization with blood flow restriction training in unilateral lumbar radiculopathy.

ØTo determine the immediate effect of ipsilateral neural slider mobilization with blood flow restriction training in unilateral lumbar radiculopathy.

Hypothesis:

ØTo compare the immediate effect of contralateral versus ipsilateral neural slider mobilization with blood flow restriction training in lower extremity pain and ROM using NPRS, MODQ and universal goniometer in unilateral lumbar radiculopathy.

Null Hypothesis H0: There will be no difference in the effect of neural slider mobilization with blood flow restriction training on contralateral versus ipsilateral lower extremity pain and hip range of motion (ROM) in unilateral lumbar radiculopathy.

•Alternate Hypothesis H1: : There will be a difference in the effect of neural slider mobilization with blood flow restriction training on contralateral versus ipsilateral lower extremity pain and hip range of motion (ROM) in unilateral lumbar radiculopathy.

Research question:

What is the comparative effect of contralateral versus ipsilateral neural slider mobilization with blood flow restriction training on lower extremity pain and hip range of motion (ROM) in unilateral lumbar radiculopathy?

Inclusion criteria:

Participants:

ØAll gender in the age group of 25-60 years.4

ØDiagnosed with subacute or chronic-stage low back pain with unilateral radiculopathy involving the sciatic nerve and its branches.

ØPain intensity score of 3-7 on Numeric Pain Rating Scale (NPRS).

ØHip range of motion below 120 o

ØWilling to participate and who can comprehend the commands.

Exclusion criteria:

Participants:

ØExtruded disc, inflammatory or other specific disorders of the spine such as ankylosing spondylitis, Paget’s disease, vertebral collapse, rheumatoid arthritis, spondylolisthesis, severe osteoporosis.1

ØRed flags for neural mobilization such as trauma, cancer, and infection and pregnant women, fractures of lower limb or spine within the past six months 4

ØNeurological deficits like stroke, SCI, PNI, myelopathy, multiple sclerosis.

ØRed flags for blood flow restriction training such as skin disorders like allergic

conditions, open wounds, active infection.

ØMusculoskeletal disorders, vascular disorder, cardiopulmonary disorders and psychological issues.

ØFeatures of vascular involvement like pallor, cyanosis, edema , lymphedema in lower limb.

Procedure:

•Prior to the commencement of the study, an ethical clearance will be obtained by Institutional Ethical Committee.

•The study will be registered under Clinical Trial Registry- India (CTRI). The intervention will begin once the CTRI registration number is obtained.

•Subject will be briefed about the purpose of the study

•All the subjects will be screened and then recruited as per the inclusion and exclusion criteria.

A written informed consent will be given to the participants in their own language and those consenting to participate in the study will be presented with the intervention.

•Brief demographic data will be obtained from each prior to the assessment.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
None

入排标准

年龄范围
25.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Participants: All gender in the age group of 25-60 years.4 Diagnosed with subacute or chronic-stage low back pain with unilateral radiculopathy involving the sciatic nerve and its branches.
  • Pain intensity score of 3-7 on Numeric Pain Rating Scale (NPRS).
  • Hip range of motion below 120 o Willing to participate and who can comprehend the commands.

排除标准

  • Participants: Extruded disc, inflammatory or other specific disorders of the spine such as ankylosing spondylitis, Paget’s disease, vertebral collapse, rheumatoid arthritis, spondylolisthesis, severe osteoporosis.1 Red flags for neural mobilization such as trauma, cancer, and infection and pregnant women, fractures of lower limb or spine within the past six months 4 Neurological deficits like stroke, SCI, PNI, myelopathy, multiple sclerosis.
  • Red flags for blood flow restriction training such as skin disorders like allergic conditions, open wounds, active infection.
  • Musculoskeletal disorders, vascular disorder, cardiopulmonary disorders and psychological issues.
  • Features of vascular involvement like pallor, cyanosis, edema , lymphedema in lower limb.

结局指标

主要结局

Numeric pain rating scale (NPRS)

时间窗: Assess pain using Numeric pain rating scale (NPRS) | Assess functional disability using Modified Oswestry disability questionnaire (MODQ) | Assess hip range of motion during straight leg raise using Goniometer

Modified Oswestry disability questionnaire (MODQ)

时间窗: Assess pain using Numeric pain rating scale (NPRS) | Assess functional disability using Modified Oswestry disability questionnaire (MODQ) | Assess hip range of motion during straight leg raise using Goniometer

Goniometer

时间窗: Assess pain using Numeric pain rating scale (NPRS) | Assess functional disability using Modified Oswestry disability questionnaire (MODQ) | Assess hip range of motion during straight leg raise using Goniometer

次要结局

未报告次要终点

研究者

发起方
Somesh Rajesh Takkekar
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Somesh Rajesh Takkekar

Room no 39 Advanced Physiotherapy Centre Sagar floor Dr Prabhakar Kore Hospital Belagavi Karnataka India 590010

研究点 (1)

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