- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07841405
Effect of Transfer of Energy Capacitive and Resistive on Chronic Discogenic Sciatica
Effect of Capacitive and Resistive Energy Transfer on Pain, Functional Outcome and Electrophysiological Parameters in Patients With Chronic Discogenic Sciatica
The goal of this clinical trial is to evaluate the effect of Transfer of Energy Capacitive and Resistive (TECAR) on pain, functional disability and electrophysiological parameters in adults with chronic discogenic sciatica . The main questions it aims to answer are:
• Is there significant effect of TECAR therapy on pain, functional disability and Electrophysiological parameters (H-reflex latency and amplitude) ? Researchers will compare effect of adding TECAR therapy to conventional physical therapy program (TENS, hot pack, stretching exercises and core stability exercises) Vs conventional physical therapy program alone to see if there is a beneficial effect of adding TECAR therapy to physical therapy program Participants in study group will receive TECAR therapy in addition to conventional PT program while participants in control group will receive conventional PT program
Aperçu de l'étude
Statut
Les conditions
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: OMAR ABDELAZIZ MOSTAFA, bachelor
- Numéro de téléphone: +201063019924
- E-mail: omarabdelaziz708@gmail.com
Lieux d'étude
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Giza, Egypte
- Recrutement
- Faculty of Physical Therapy Cairo University
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Contact:
- Shaimaa Mohamed Abdelmageed, Assistant Professor
- Numéro de téléphone: 0201028202856
- E-mail: shaimaa.abdelmageed@pt.cu.edu.eg
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Age between 30-50 years
- Unilateral chronic discogenic sciatica at L5-S1, MRI confirmed
- Symptom duration more than 3 months
- Pain score ≥ 4 on the Visual Analogue Scale (VAS)
- Ability to participate in outpatient physiotherapy
Exclusion Criteria:
- Previous lumbar spine surgery
- Pacemaker or metallic implants
- Peripheral neuropathy or systemic neurological disorders
- Severe sensory loss
- Skin lesions at the treatment site
- Recent corticosteroid injection (< 3 weeks)
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: Study (TECAR) Group
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Autres noms:
conventional physical therapy program will include TENS, hot pack, stretching exercises and core stabilization exercises for 3 sessions per week for four weeks. |
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Comparateur actif: Control (Conventional treatment) Group
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conventional physical therapy program will include TENS, hot pack, stretching exercises and core stabilization exercises for 3 sessions per week for four weeks. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Pain intensity
Délai: from enrollment to the end of treatment at 4 weeks
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lower back pain will be assessed though Visual Analogue Scale (VAS) which is used to measure the severity of pain. It is a straight line with one end representing no pain and the other end representing the worst imaginable pain. The subject will mark a point on the line that corresponds to the current level of pain he or she experiences. Higher values indicate higher levels of pain while lower values indicate lower levels of pain |
from enrollment to the end of treatment at 4 weeks
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Hoffmann reflex (H-reflex)
Délai: from enrollment to the end of treatment at 4 weeks
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H-reflex has been measured in the soleus muscle by stimulating the tibial nerve with a one-millisecond pulse at 0.2pps of H-max. The peak-to-peak amplitude of the highest recorded H-reflex and the latencies of four spaced traces for both lower extremities will be averaged for each participant. lower amplitudes and delayed latencies indicate more damage to nerve root, while higher amplitudes and shorter latencies indicate less damage |
from enrollment to the end of treatment at 4 weeks
|
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functional disability
Délai: from enrollment to the end of treatment at 4 weeks
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Functional disability will be evaluated using the Oswestry Disability Index (ODI), which is considered the gold standard for assessing disability in low back pain and radiculopathy. The ODI consists of 10 sections evaluating daily activities such as lifting, walking, sitting, and personal care. It is scored from 0% to 100%, where higher percentages represent more severe functional impairment |
from enrollment to the end of treatment at 4 weeks
|
Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- P.T.REC/012/006312
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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