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临床试验/NCT07756905
NCT07756905招募中不适用

Effects of Somatosensory Motor Control With and Without Kinesio Tape on Pain, Range of Motion of Lumbar, Dynamic Balance and Function Disability in Patients With Sciatica

Riphah International University1 个研究点 分布在 1 个国家目标入组 58 人开始时间: 2025年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
58
试验地点
1
主要终点
Visual Analogue Scale

研究概览

简要总结

Sciatica can be defined as a radicular pain that runs through the sciatic nerve from the lower back to the lower limbs and also may be associated with weakness or numbness in the muscles. These symptoms may affect proprioception, dynamic balance and functional mobility, which result in limitations of activity and disability. Training to improve somatosensory motor control has been shown to be effective in improving coordination and postural stability and Kinesio taping has the potential to increase proprioceptive input, decrease pain and aid functional recovery.

详细描述

To evaluate the additional effects of kinesio taping when added to somatosensory motor control training on pain, active range of motion of the lumbar spine, proprioceptive related postural control, dynamic balance and functional disability in people with discogenic sciatica.

The study was an accessor-blinded randomized controlled trial approved by the ethical council of Riphah College of Rehabilitation & Allied Health Sciences and was carried out for 11 months in 4 hospitals at Sialkot. 58 Participants were randomized; among which 54 participants completed the intervention and were included in per-protocol analysis with 27 participants in each group. During the 6-week intervention period, Group A was administered with somatosensory motor control training, conventional therapy, and Kinesio taping; while Group B was administered with the same intervention with the exception of Kinesio taping. The following outcome measures were used: Visual Analog Scale, Oswestry Disability Index, Modified Schober Test, Y-Balance Test, Romberg Test, and Tandem Stand Test. Data was analyzed in SPSS version 25 with statistical significance being considered as p<0.05.

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

An independent assessor, who is blinded to the group allocations, will be responsible for evaluating outcomes, including pain, range of motion of lumbar, dynamic balance and function disability in patients with sciatica.

入排标准

年龄范围
35 Years 至 50 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •• Both male and females.
  • •Age between 35-50 years.
  • •Discogenic pain due to Diagnosed herniation lumbar disc L4/L5 and L5/S1 (confirmed by MRI).
  • •unilateral leg pain radiating below the knee accompanied by numbness, tingling, or weakness in the affected leg.
  • •Pain persists between 3-6 months.
  • •Positive Straight Leg Raise (SLR) test between 40° to 70°, suggestive of neural irritation.

排除标准

  • •• Patients with inflammatory diseases like ankylosing spondylitis, vertebral collapse, rheumatoid arthritis, stenosis, spondylolisthesis, or osteoporosis.
  • •Recent spinal surgery
  • •Abdominal or lower limb surgery
  • •Pregnancy
  • •Skin allergies

研究组 & 干预措施

Group A

Experimental

somatosensory motor control (include PNF, somatosensory exercises and vestibular exercises) + Kinesiology taping+ conventional Treatment Total Time per Session: 45-60 minutes Frequency: 3 sessions per week Total Duration: 6 weeks

Assessment Points:

Pre-treatment (Baseline) Post-treatment (End of 6th week)

干预措施: somatosensory motor control exercises, Kinesiology taping, and conventional Treatment (Other)

Group B

Active Comparator

somatosensory motor control (include PNF, somatosensory exercises and vestibular exercises) + conventional Treatment Total Time per Session: 45-60 minutes Frequency: 3 sessions per week Total Duration: 6 weeks

Assessment Points:

Pre-treatment (Baseline) Post-treatment (End of 6th week)

干预措施: somatosensory motor control and conventional Treatment (Other)

结局指标

主要结局

Visual Analogue Scale

时间窗: Baseline and post 6 weeks

The Visual Analogue Scale (VAS) is scored by measuring the distance in millimeters (from 0 to 100 mm) or centimeters (0 to 10 cm) on a straight line between the "no pain" anchor and the patient's mark. Higher numbers mean more intense symptoms.

lumbar range of motion

时间窗: Baseline and post 6 weeks

Modified Schober Test, The Schober Test evaluates lower back movement. Scoring is based on how much the distance between marked points on the spine increases during forward bending. A starting 15 cm span should stretch to 20 cm or more; an increase under 5 cm shows reduced flexibility

dynamic balance

时间窗: Baseline and post 6 weeks

Y balance test, The Y Balance Test is a standardized three-direction reach test (anterior, posteromedial, posterolateral) used to assess dynamic balance, limb asymmetry, and injury risk, with anterior reach asymmetry \>4 cm and composite scores below \~89-94% linked to higher injury risk.

functional disability

时间窗: Baseline and post 6 weeks

Oswestry Disability Index (ODI), The Oswestry Disability Index (ODI) is a 10-item patient questionnaire scored from 0 to 5 per question. Total the points, divide by the maximum possible score (usually 50, or 5 × questions answered), and multiply by 100 to get a percentage score from 0% to 100%. You can calculate scores interactively using tools like OrthoToolKit.

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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