- ICH GCP
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- Essai clinique NCT07912047
Effects of Spinal Mobilization With and Without Clinical Pilates in Patients With Lumbar Disc Herniationc Herniation
EFFECTS OF SPINAL MOBILIZATION WITH AND WITHOUT CLINICAL PILATES ON PAIN, LUMBAR MOBILITY AND DISABILITY IN PATIENTS WITH LUMBAR DISC HERNIATION
Lumbar disc herniation is described by The North American Spine Society (NASS) as the confined movement of the disc material like nucleus pulposus and annulus fibrosis outside the limitations of the intervertebral disc space causing low back pain among adults. Low back pain become the most prevalent and common in adult generation. Lumbar disc herniation is the most common reason of low back pain in grown-ups of age saturation of 30 to 50 years. Lumbar disc herniation is affection almost 1 to 3% of the population per annum. There are many risk factors including alcohol, smoking, high intensity activities causing high load on your back or lifting high weight objects and genetic and environmental factors. The most affected and endorsed first line intervention protocol for lumbar disc herniation comprise of physical therapy management, life style adjustments and epidural steroid shots. This first line conservative management is used to avoid the risks of surgery and further complications. Spinal mobilization is used as the most effective and suggested option to help increase the mobility of the lumbar spine and reduce pain and disability chances in lumbar disc herniation patients. Clinical Pilates Exercise is used to upsurge core firmness and functional activity as well as boost the neuromuscular re-education in patients with disc herniation. The objective of this study is to compare the effects of spinal mobilization with or without Clinical Pilates on pain, lumbar mobility and disability in patients with lumbar disc herniation. Evaluation will be done by using NPRS, RODQ and Bubble Inclinometer. Non-probability convenient sampling will be used and the subjects will be allocated to two groups by random allocation. Group A will receive spinal mobilization and Group B will receive spinal mobilization along with Pilates. Both groups will receive hot pack and TENS for 10 minutes as baseline treatment of herniated disc back pain before techniques application. Both groups will receive 12 sessions for the period of 4 weeks. Measurements of all the outcome variables will be taken at baseline, 2nd and 4th week. Results will be analyzed by using SPSS 24.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Punjab Province
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Lahore, Punjab Province, Pakistan, 54000
- UMT
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Contact:
- Muqadas Chaudary Dr. Muqadas Chaudary, TDPT
- Numéro de téléphone: +923448466051
- E-mail: muqadas.chaudary@umt.edu.pk
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Contact:
- Rabia Jawa COD, Mphil
- Numéro de téléphone: 6045 +923434570838
- E-mail: rabia.jawa@umt.edu.pk
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Sous-enquêteur:
- Syeda Shaista Altaf
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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:
Clinically diagnosed patients with lumbar disc herniation. Both genders. Age ranging from 30 to 50 years. Unilateral radiating pain. low back pain for at least more than 3 weeks ranges from 4-6 on NPRS
Exclusion Criteria:
Diagnosis of systemic metabolic and/or neurological disorder. Neuropathic pain due to damage of the nervous system Red flags conditions like infection, cauda equina syndrome and fractures Participants who had undergone surgery for LBP. Pregnancy
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: HOT PACK+ TENS + SPINAL MOBILIZATION
Group A will receive spinal mobilization along hot pack for 10 minutes and TENS for 10 minutes. In this group, participants will receive graded posteroanterior (PA) mobilizations on the affected lumbar segment L1-L5. The therapist will use oscillatory mobilizations of grade 1 and 2 within the pain free range depending on the patient's response and clinical evidences. To apply spinal mobilization the members will be placed in an appropriate prone lying position on a couch and with hands on their respective sides. The therapist will place the hypothenar (ulnar) surface of the hand on the spinous process of the symptomatic lumbar vertebrae (L1-L5) while the other hand will be placed over the first hand to increase the force. Mobilization will be applied for 4 times with a 30-60 second of PA pressure and a resting interval of 20 sec. Apply 2 to 3 oscillations per sec. We'll start with the grade 1 and check the patient's response and gradually increase the grade of oscillations from 1 to 2 |
Group A will receive spinal mobilization along hot pack for 10 minutes and TENS for 10 minutes. In this group, participants will receive graded posteroanterior (PA) mobilizations on the affected lumbar segment L1-L5. The therapist will use oscillatory mobilizations of grade 1 and 2 within the pain free range depending on the patient's response and clinical evidences. To apply spinal mobilization the members will be placed in an appropriate prone lying position on a couch and with hands on their respective sides. The therapist will place the hypothenar (ulnar) surface of the hand on the spinous process of the symptomatic lumbar vertebrae (L1-L5) while the other hand will be placed over the first hand to increase the force. Mobilization will be applied for 4 times with a 30-60 second of PA pressure and a resting interval of 20 sec. Apply 2 to 3 oscillations per sec. We'll start with the grade 1 and check the patient's response and gradually increase the grade of oscillations from 1 to 2 |
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Comparateur actif: HOT PACK+ TENS+ SPINAL MOBILIZATION + CLINICAL PILATES
For spinal mobilization, the participants will receive the same protocol just like the members of group A. However, the participants of this group will receive a session of Clinical Pilates Exercises. The exercises will be given to all the members of group B 3 days per week and the study continues for 4 weeks. The exercise session will be divided into 4 weeks |
For spinal mobilization, the participants will receive the same protocol just like the members of group A. However, the participants of this group will receive a session of Clinical Pilates Exercises. The exercises will be given to all the members of group B 3 days per week and the study continues for 4 weeks. The exercise session will be divided into 4 weeks. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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NUMERIC PAIN RATING SCALE
Délai: BASELINE AND 4 WEEKS
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Numeric Rating Scale (NPRS) is most frequently used instruments to measure pain intensity in musculoskeletal pain. The 11-point numeric with 0 representing No pain, 1-3 representing Mild Pain (nagging, annoying, interfering little with ADLs), 4-6 representing Moderate Pains (interferes significantly with ADLs), 7-10 representing Sever Pain (disabling, unable to perform ADLs). It is evident that the NPRS are practical to use, yield accurate scores, and correspond to multi-item patient-reported outcome measures. More work is needed to improve the scales' responsiveness (meaningful change) and how change scores are interpreted. In neck pain research and management, the NPRS can be a helpful single-item evaluation to support more thorough multi-item patient-reported outcome measures |
BASELINE AND 4 WEEKS
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REVISED OSWESTERY DISABILITY INDEX
Délai: BASELINE AND 4 WEEKS
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The Oswestry Disability Index (also known as the Oswestry Low Back Pain Disability Questionnaire) is an extremely important tool that researchers and disability evaluators use to measure a patient's permanent functional disability. The test is considered the 'gold standard' of low back functional outcome tools. This scale contain question related to functional activities of pain intensity, personal care, lifting, walking, sitting, standing, sleeping, sex life, social life and travelling. For patients understanding, URDU version is used. Interpretation of scale are 0% to 20% for minimal disability, 21% to 40% for moderate disability, 41 % to 60 % for severe disability 61% to 80 % for crippled and 81 % to 100 %. Bed-bound |
BASELINE AND 4 WEEKS
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BUBBLE INCLINOMETER
Délai: BASELINE AND 4 WEEKS
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The spinous process of the 1st sacral vertebra and the 12th thoracic vertebra were considered as reference points for measuring the range of motion in bending forward and backward. The spinous process of the 12th thoracic vertebra was considered as reference point for measuring the range of motion of lumbar side flexion. Two bubble inclinometers were used simultaneously for measuring the lumbar range of motion when bending forward (in the standing position), and one bubble inclinometer for measuring the lumbar range of motion for back extension (in the standing) and side flexion (in the standing position). The actual ranges of motion of lumbar area when bending forward and backward were calculated by subtracting the number (degree) obtained by the lower inclinometer from the number (degree) obtained by the upper inclinometer |
BASELINE AND 4 WEEKS
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Collaborateurs et enquêteurs
Publications et liens utiles
Liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
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
- RE-170-2026
Plan pour les données individuelles des participants (IPD)
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Informations sur les médicaments et les dispositifs, documents d'étude
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