- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: Imran Amjad, PhD
- Numero di telefono: 03324390125
- Email: imran.amjad@riphah.edu.pk
Luoghi di studio
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Sialkot, Pakistan
- Reclutamento
- Civil hospital Sialkot
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Contatto:
- Muhammad Tariq
- Numero di telefono: 03318614555
- Email: tmir5250@gmail.com
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
Accetta volontari sani
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: 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) |
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Comparatore attivo: 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) |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Visual Analogue Scale
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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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Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Aiza Yousaf, MSOMPT, Riphah International University
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Inizio studio (Effettivo)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- REC/RCR & AHS/25/0241
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