- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07734909
Effectiveness of Combined Diaphragm Strengthening and Core Stability Exercises in Individuals With Lumbar Instability
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: Ahmed Hesham Abd El-Mawgoud, B.Sc
- Numero di telefono: +20 11 20484750
- Email: ahmed.hesham.hassona@gmail.com
Backup dei contatti dello studio
- Nome: Mona AbdelRaouf Moursy, PhD
Luoghi di studio
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Cairo, Egitto
- Outpatient clinic of the faculty of physical therapy, Cairo University
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Contatto:
- Ahmed Hesham Abd El-Mawgoud, B.Sc
- Numero di telefono: +20 11 20484750
- Email: ahmed.hesham.hassona@gmail.com
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
Accetta volontari sani
Descrizione
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).
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: 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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Comparatore attivo: 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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Pain intensity assessed using the Visual Analogue Scale (VAS)
Lasso di tempo: 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
Lasso di tempo: 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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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Core muscle stability assessed using a Pressure Biofeedback Unit (PBU)
Lasso di tempo: 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)
Lasso di tempo: 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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Collaboratori e investigatori
Sponsor
Investigatori
- Cattedra di studio: Ahmad Mahdi Ahmad, PhD, Professor, Cairo University
- Direttore dello studio: Maged Mohamed Samy Abouelsoud, PhD, Professor, Ain Shams University
- Direttore dello studio: Mona AbdelRaouf Moursy, Assist. Professor, Cairo University
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Inizio studio (Stimato)
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
Altri numeri di identificazione dello studio
- P.T.REC/012/006064
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