- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07734909
Effectiveness of Combined Diaphragm Strengthening and Core Stability Exercises in Individuals With Lumbar Instability
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Lumbar instability is a common medical problem. There is a 50-70% chance of a person suffering from LBP during his or her lifetime having lumbar instability. It is often referred to as clinical spinal instability. Clinical spinal instability is controversial and poorly understood. Properly conducted clinical studies of patients with spinal pain and documented clinical instability would be good to explore this concept. However, pursuing such a course is difficult.
The diaphragm has a dual role in respiration and postural control. Evidence suggests that current core stability exercises for low back pain are superior to minimal or no treatment, however, no more beneficial than general exercises and/or manual therapy. There appears to be a higher focus on the transverses abdominis and multifidi muscles and minimal attention to the diaphragm.
We propose that any form of core stabilization exercises for low back pain rehabilitation should consider the diaphragm. Core stabilization program could commence with facilitation of normal breathing patterns and progressive systematic restoration of the postural control role of the diaphragm muscle.
So, the aim of this trial is to determine whether combining diaphragmatic strengthening exercises with core stability training leads to faster improvements in pain and instability in individuals with lumbar instability, compared to traditional core exercises alone.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Ahmed Hesham Abd El-Mawgoud, B.Sc
- Numéro de téléphone: +20 11 20484750
- E-mail: ahmed.hesham.hassona@gmail.com
Sauvegarde des contacts de l'étude
- Nom: Mona AbdelRaouf Moursy, PhD
Lieux d'étude
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Cairo, Egypte
- Outpatient clinic of the faculty of physical therapy, Cairo University
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Contact:
- Ahmed Hesham Abd El-Mawgoud, B.Sc
- Numéro de téléphone: +20 11 20484750
- E-mail: ahmed.hesham.hassona@gmail.com
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
Accepte les volontaires sains
La description
Inclusion Criteria:
- Age between 25 and 35 years.
- Positive prone instability test.
- Straight leg raising >90 degrees.
- Pain assessment on VAS >5/10.
- All patients will suffer from clinical lumber instability (characterized by excessive movement in specific segments during active movement and posterior-anterior spring test causing large movements and pain)
Exclusion Criteria:
- Patients with cardiovascular diseases.
- Patients with cerebrovascular diseases.
- Patients with neurological diseases.
- Patients with any attention disorders or physical disability.
- Patients with any diseases/conditions preventing physical activity participation.
- Patients with history of back surgery, inflammatory spinal disorder, deformed vertebrae, fracture, or neurological radiating pain.
- Patients with central obesity (A waist to hip ratio >0.90 in males or > 0.85 in females).
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: Combined diaphragm strengthening + Core stability exercises
It will include patients that will perform combined diaphragm strengthening and core stability exercises.
The treatment program will be 45 minutes, 3 times a week, for 8 weeks.
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Participants will receive supervised diaphragm strengthening exercises combined with core stability training, three sessions per week for 8 weeks (45 minutes/session).
Diaphragm strengthening will be performed using an elastic TheraBand wrapped around the thoracolumbar junction to provide progressive inspiratory resistance, with intensity progressed according to the Borg Rating of Perceived Exertion (RPE: 11 during weeks 1-2, 13 during weeks 3-5, and 15 during weeks 6-8).
Participants will receive supervised core stability exercises only, three sessions per week for 8 weeks (45 minutes/session).
The exercise program includes the abdominal drawing-in maneuver (ADIM), side-bridge, and quadruped exercises, with progressive increases in exercise difficulty every two weeks.
Participants will perform the same exercise progression as the intervention group but without diaphragm strengthening or TheraBand resistance.
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Comparateur actif: Core stability exercises
It will include patients that will perform core stability exercises alone.
The treatment program will be 45 minutes, 3 times a week, for 8 weeks.
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Participants will receive supervised core stability exercises only, three sessions per week for 8 weeks (45 minutes/session).
The exercise program includes the abdominal drawing-in maneuver (ADIM), side-bridge, and quadruped exercises, with progressive increases in exercise difficulty every two weeks.
Participants will perform the same exercise progression as the intervention group but without diaphragm strengthening or TheraBand resistance.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Pain intensity assessed using the Visual Analogue Scale (VAS)
Délai: 8 weeks
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Pain intensity will be evaluated using a 10-cm Visual Analogue Scale (VAS), with scores ranging from 0 (no pain) to 10 (worst imaginable pain).
Higher scores indicate greater pain intensity.
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8 weeks
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Pressure pain threshold assessed by pressure algometry
Délai: 8 weeks
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Pressure pain threshold will be measured over the lumbar paraspinal muscles using a handheld pressure algometer.
Higher values indicate reduced pain sensitivity.
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8 weeks
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Core muscle stability assessed using a Pressure Biofeedback Unit (PBU)
Délai: 8 weeks
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Core muscle stability will be assessed using a Pressure Biofeedback Unit during abdominal drawing-in tasks.
Improved pressure control indicates better activation of the local stabilizing muscles.
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8 weeks
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Functional disability assessed using the Oswestry Disability Index (ODI)
Délai: 8 weeks
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Functional disability related to low back pain will be evaluated using the Oswestry Disability Index (ODI).
Scores range from 0 to 100%, with higher scores indicating greater disability.
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8 weeks
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chaise d'étude: Ahmad Mahdi Ahmad, PhD, Professor, Cairo University
- Directeur d'études: Maged Mohamed Samy Abouelsoud, PhD, Professor, Ain Shams University
- Directeur d'études: Mona AbdelRaouf Moursy, Assist. Professor, Cairo University
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
Mots clés
Autres numéros d'identification d'étude
- P.T.REC/012/006064
Informations sur les médicaments et les dispositifs, documents d'étude
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