- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07628439
Effects of Mulligan Belt Traction Versus Fisted Traction in Patients With Lower Cervical Spine Radiculopathy
Effects of Mulligan Belt Traction Versus Fisted Traction on Pain, Range of Motion and Disability Level in Patients With Lower Cervical Spine Radiculopathy
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
-
Punjab Province
-
Lahore, Punjab Province, Pakistan, 54000
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
Accepte les volontaires sains
La description
Inclusion Criteria:• Age 25-60 years
- Both Male and Female
- Clinically or radiologically diagnosed lower cervical radiculopathy(C5-C7)
- Neck pain radiating to the arm and hand
- Positive Spurling's Test or Upper Limb Tension test
- Subacute to chronic phase (>4 weeks to 6< weeks)
- Moderate pain (VAS> 4/10)
- Evident by a score on Neck Disability Index (NDI >20%)
- Able and willing to give informed consent and follow the protocol
- Cervical spine active range of motion (CSAROM) Exclusion Criteria:• Cervical Fracture
- Thoracic outlet syndrome or carpal tunnel syndrome
- History of previous cervical surgery
- Osteoporosis of cervical spine
- Sign of myelopathy
- Severe cervical disc herniation with cord compression
- Red flag signs (Rheumatoid arthritis, history of trauma, ankylosing spondylitis, prolonged steroid used and malignancy
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 |
|---|---|
|
Expérimental: conventional group
Conventional physiotherapy which include cervical traction, hot pack and isometric strengthening exercises for lower cervical radiculopathy
|
Patient Position:
Therapist Position:
Belt Placement:
Application of Traction:
Duration: • Traction is applied for 10-30 seconds per repetition, repeated 3-5 times per session base Sit upright in a chair with back support. • Keep your spine straight and head in a neutral position. Hand Placement:
Traction Technique:
|
|
Comparateur actif: conventional therapy
Conventional physiotherapy which include cervical traction, hot pack and isometric strengthening exercises for lower cervical radiculopathy
|
Patient Position:
Therapist Position:
Belt Placement:
Application of Traction:
Duration: • Traction is applied for 10-30 seconds per repetition, repeated 3-5 times per session base Sit upright in a chair with back support. • Keep your spine straight and head in a neutral position. Hand Placement:
Traction Technique:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Neck Disability Index
Délai: baseline to 4 week
|
The NDI contains 10 items - 7 relating to activities of daily living, 2 relating to pain and 1 relating to concentration items is scored from 0-5, and the total score is expressed as a percentage (total possible score, 100%), with higher scores corresponding to greater disability.
Scoring the NDI: 0 - 4 = No disability 5 - 14 = Mild disability 15 - 24 = Moderate disability 25 - 34 = Severe disability 35 or over = Complete disability
|
baseline to 4 week
|
|
Numeric pain rating scale
Délai: baseline to 4 week
|
The NPRS is a reliable and effective tool for measuring pain.
A straight line is drawn on the evaluation sheet, labeled from '0' to '10', where '0' represents no pain and '10' indicates the worst possible pain.
Patients are asked to mark a point on the line that reflects the intensity of pain they are experiencing at the time of assessment
|
baseline to 4 week
|
|
Cervical Range of Motion
Délai: baseline to 4 week
|
Cervical Flexion (Looking Down) Position: The patient sits upright. Goniometer Axis: Placed at the external auditory meatus (ear). Stationary Arm: Kept perpendicular to the floor. Moving Arm: Aligned with the base of the nose. Normal Range: 0 to 45 degrees 2 Cervical Extension (Looking Up) Position: Patient remains seated upright. Goniometer Axis: Centered at the external auditory meatus. Stationary Arm: Vertical, perpendicular to the floor. Moving Arm: Follows the line of the nose. Normal Range: 0 to 45 degrees 3. Cervical Lateral Flexion (Side Bending) Position: Patient sits straight. Goniometer Axis: Over the C7 spinous process. Stationary Arm: Aligned vertically along the spine. Moving Arm: Follows the midline of the head toward the occipital bone. Normal Range: 0 to 45 degrees 4.Cervical Rotation (Turning Head Side to Side) Position: Patient remains upright. Goniometer Axis: Placed at the top center of the head. Stationary Arm: Imaginary line between both shoulder tips. |
baseline to 4 week
|
Collaborateurs et enquêteurs
Parrainer
Publications et liens utiles
Publications générales
- Caridi JM, Pumberger M, Hughes AP. Cervical radiculopathy: a review. HSS J. 2011 Oct;7(3):265-72. doi: 10.1007/s11420-011-9218-z. Epub 2011 Sep 9.
- Kim HJ, Nemani VM, Piyaskulkaew C, Vargas SR, Riew KD. Cervical Radiculopathy: Incidence and Treatment of 1,420 Consecutive Cases. Asian Spine J. 2016 Apr;10(2):231-7. doi: 10.4184/asj.2016.10.2.231. Epub 2016 Apr 15.
- Peene L, Cohen SP, Brouwer B, James R, Wolff A, Van Boxem K, Van Zundert J. 2. Cervical radicular pain. Pain Pract. 2023 Sep;23(7):800-817. doi: 10.1111/papr.13252. Epub 2023 Jun 4.
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
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- REC/RCR&AHS/25/0210
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
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
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .