- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07917611
Effect of Retro Walking in Patients With Sacroiliac Joint Dysfunction
Effect of Retro Walking on Isokinetic Peak Torque of Lower Limb Muscles in Patients With Sacroiliac Joint Dysfunction
The goal of this clinical trial is to investigate the effect of adding retro-walking (RW) to core stabilization exercises (CSE) on isokinetic peak torque of lower limb muscles, pain severity, and disability level in patients with sacroiliac joint dysfunction(SIJD).The main questions it aims to answer are:
Will there be any effect for the combined application of RW training and CSE on isokinetic peak torques of, hip extensors and abductors, knee extensors, and ankle planter-flexors, pain severity, and disability level in patients with SIJD? Will there be any difference between the combined application of RW training and CSE and the solo application of CSE on isokinetic peak torques hip extensors and abductors, knee extensors, and ankle planter-flexors, pain severity, and disability level in patients with SIJD?
Aperçu de l'étude
Statut
Les conditions
Description détaillée
One of the most overlooked sources of low back pain (LBP) is the sacroiliac joint dysfunction (SIJD). The reported prevalence of chronic mechanical LBP originating from the sacroiliac joint (SIJ) ranges from 15% to 30% with females being affected more than males. SIJ is the largest axial joint in the body that connects the spine to the pelvis and thus transfers load from the lumbar spine to lower extremities and vice versa. During weight bearing activities, the ankle, knee and hip act as a linked system minimizing the transmission of force to the pelvis and spine.
Some studies investigated electromyographic activity of gluteus maximus, gluteus medius and other lumbo-pelvic muscles in patients with SIJD. They found reduced activity of these muscles and delayed onset of activation in SIJD compared with the controls. Also, recent studies found there was a relation between pelvic, and lower limb injuries and SIJD.
Treatment of SIJ pain is variable, and there are no guidelines or an appropriate management plan for this dysfunction. Core Stabilization Exercises (CSE) are a common form of exercise therapy used to treat LBP and SIJD. Backward walking (BW) or retro-walking (RW) is a recently emerging exercise that helps enhance the balance, muscle strength of the lower limbs and hamstring flexibility. Reviewing the literature revealed that there was no study investigated the effect of BW training on lower limb muscles' strength, pain, and disability in patients with SIJD. Yet, there is a gap in literature regarding the effect of RW training on hip, knee, and ankle muscles' strength in such patients. Furthermore, the effect of adding RW training to CSE on such variables wasn't previously investigated. So, the current study will be conducted to fill this gap, by investigating the effect of adding RW to CSE on isokinetic peak torques of hip extensors and abductors, knee extensors, ankle planter-flexors, pain severity, and disability level in patients with SIJD. Additionally, this study aims to compare the changes in the selected parameters after applying RW in addition to CSE versus applying CSE only in patients with SIJD.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Age ranging from 20-40 years.
- pain lasting for more than 3 months
- ≥ 4 in diagnostic scoring system (Kurosawa et al., 2017).
- 3 or more positive provocative test of SIJ tests (distraction test, compression test, sacral trust, thigh trust test, gaenslen test).
- Pain in or around the sacroiliac region with or without leg pain.
Exclusion Criteria:
- Midline or symmetrical pain above the level of L5 or radicular pain with neurological deficits (sensory or motor deficit).
- A history of spinal surgery, infection, tumors fracture of the spine, pelvis or lower extremities.
- Hospitalization for severe trauma or car accident.
- Pregnancy or lactation.
- Any systemic disease such as arthritis, tuberculosis.
- Leg length discrepancy and scoliosis.
- Injection of corticosteroids or anesthetics in the SIJ during the previous month.
- Participating in physical therapy for 3 months prior the study.
- Taking non-steroidal anti-inflammatory drugs during the therapy.
- Participating in any regular exercise.
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: Experimental group
Patients will perform core stabilization exercises combined with backward walking training. The intervention will be administered for 3 times per week for 6 weeks. Each session lasts for approximately 40-50 minutes. |
core stabilization exercises will be performed followed by backward walking three times per week for six weeks. core stabilization exercises will be performed three times per week for six weeks. Each exercise will be repeated 15 times, with a brief rest interval of 3s between repetitions and 1-min between exercises. |
|
Comparateur actif: Control group
Patients will perform core stabilization exercises only. The intervention will be administered for 3 times per week for 6 weeks. Each session lasts for approximately 20-30 minutes. |
core stabilization exercises will be performed followed by backward walking three times per week for six weeks. core stabilization exercises will be performed three times per week for six weeks. Each exercise will be repeated 15 times, with a brief rest interval of 3s between repetitions and 1-min between exercises. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Isokinetic peak torque of lower limb muscles
Délai: The isokinetic peak torques of the four tested muscles will be measured at the beginning and after six weeks for the two tested groups
|
Biodex System 3 Multi-Joint system testing and rehabilitation (Biodex Medical system, Shirley, NY, USA) will be used to measure peak torques of hip extensors and abductors, in addition to knee extensors and ankle planter flexors at an angular velocity of 60°/sec. |
The isokinetic peak torques of the four tested muscles will be measured at the beginning and after six weeks for the two tested groups
|
|
Pain intensity
Délai: VAS pain score will be measured at the beginning and after six weeks for the two tested groups
|
Visual analog scale (VAS) will be used for measuring the pain intensity. |
VAS pain score will be measured at the beginning and after six weeks for the two tested groups
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Functional disability
Délai: ODI score will be measured at the beginning and after six weeks for the two tested groups
|
Oswestry disability index (ODI) will be used for assessing pain related disability and quality of life |
ODI score will be measured at the beginning and after six weeks for the two tested groups
|
Collaborateurs et enquêteurs
Parrainer
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
Autres numéros d'identification d'étude
- P.T.REC/012/005650
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
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 .