- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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
Studieöversikt
Status
Betingelser
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Imran Amjad, PhD
- Telefonnummer: 03324390125
- E-post: imran.amjad@riphah.edu.pk
Studieorter
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Sialkot, Pakistan
- Rekrytering
- Civil hospital Sialkot
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Kontakt:
- Muhammad Tariq
- Telefonnummer: 03318614555
- E-post: tmir5250@gmail.com
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
Tar emot friska volontärer
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: 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) |
|
Aktiv komparator: 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) |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Visual Analogue Scale
Tidsram: 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.
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Baseline and post 6 weeks
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lumbar range of motion
Tidsram: 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
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Baseline and post 6 weeks
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dynamic balance
Tidsram: 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
Tidsram: 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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Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Aiza Yousaf, MSOMPT, Riphah International University
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- REC/RCR & AHS/25/0241
Plan för individuella deltagardata (IPD)
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