- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07756905
Effect of Somatosensory Motor Control With and Without Kinesio Tape in Patients With Sciatica
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
Study Overview
Status
Conditions
Detailed Description
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Imran Amjad, PhD
- Phone Number: 03324390125
- Email: imran.amjad@riphah.edu.pk
Study Locations
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Sialkot, Pakistan
- Recruiting
- Civil hospital Sialkot
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Contact:
- Muhammad Tariq
- Phone Number: 03318614555
- Email: tmir5250@gmail.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
• 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.
Exclusion Criteria:
• 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Group A
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) |
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) |
|
Active Comparator: Group B
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) |
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) |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Visual Analogue Scale
Time Frame: Baseline and post 6 weeks
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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.
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Baseline and post 6 weeks
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lumbar range of motion
Time Frame: Baseline and post 6 weeks
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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
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Baseline and post 6 weeks
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dynamic balance
Time Frame: Baseline and post 6 weeks
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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.
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Baseline and post 6 weeks
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functional disability
Time Frame: Baseline and post 6 weeks
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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.
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Baseline and post 6 weeks
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Aiza Yousaf, MSOMPT, Riphah International University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/RCR & AHS/25/0241
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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