- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07567703
Comparison of Laser and Shockwave Therapy for Piriformis Syndrome With Adjunctive Exercise (LASWEX-PS)
A Comparative Study of Laser Therapy and Shockwave Therapy in the Treatment of Piriformis Syndrome: The Role of Exercise as an Adjunctive Treatment
Aperçu de l'étude
Statut
Les conditions
Description détaillée
Piriformis syndrome is a common musculoskeletal condition that contributes to chronic low back and gluteal pain, often leading to functional limitations. This prospective randomized controlled trial was conducted to compare the effectiveness of low-level laser therapy (LLLT) combined with therapeutic exercise versus radial extracorporeal shockwave therapy (rESWT) combined with exercise in patients with piriformis syndrome.
A total of 70 participants were randomly assigned into two equal groups. Both interventions were administered over a period of four weeks, with follow-up assessment conducted one month post-treatment. Outcome measures included pain intensity using the Visual Analog Scale (VAS), functional disability using the Oswestry Disability Index (ODI), hip range of motion (ROM), and quality of life using the Short Form-36 (SF-36).
Inclusion criteria:
Adults aged 18 to 65 years who had a confirmed diagnosis of piriformis syndrome. piriformis syndrome required a positive FAIR test and EMG evidence of sciatic nerve involvement. Eligible participants had chronic symptoms lasting at least three months and a baseline Visual Analog Scale (VAS) pain score of ≥4.
Exclusion criteria:
Participants were excluded if they had a history of surgical interventions involving the lumbar spine, sacroiliac joint, or hip; systemic inflammatory diseases such as ankylosing spondylitis or rheumatoid arthritis; neurological disorders impairing lower limb function; or were pregnant or lactating. Individuals with malignancy, bleeding disorders, or pacemaker implantation Pain Intensity measured by Visual Analogue Scale (VAS), Functional Disability - Oswestry Disability Index (ODI) was used to assess functional impairment in lower back pain and functional limitations., Range of Motion (ROM):It had been used to assess joint mobility will be assessed using a standard goniometer, Quality of Life - Short Form-36 (SF-36): Health-related quality of life will be assessed using the Short Form-36 (SF-36) questionnaire assessment performed at baseline , posttreatment after 4 weeks and 3 months follow up post treatment
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Cairo, Egypte
- Outpatient clinics of the Faculty of Physical Therapy, Beni Suef University
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La description
Inclusion Criteria:
- Adults aged 18 to 65 years who had a confirmed diagnosis of piriformis syndrome. piriformis syndrome required a positive FAIR test and EMG evidence of sciatic nerve involvement. Eligible participants had chronic symptoms lasting at least three months and a baseline Visual Analog Scale (VAS) pain score of ≥4.
Exclusion Criteria:
- Participants were excluded if they had a history of surgical interventions involving the lumbar spine, sacroiliac joint, or hip; systemic inflammatory diseases such as ankylosing spondylitis or rheumatoid arthritis; neurological disorders impairing lower limb function; or were pregnant or lactating. Individuals with malignancy, bleeding disorders, or pacemaker implantation
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: Laser + Exercise
Participants receive low-level laser therapy combined with therapeutic exercise for management of piriformis syndrome.
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Participants receive low-level laser therapy combined with a structured therapeutic exercise program for management of piriformis syndrome.
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Expérimental: Shockwave + Exercise Group
Participants receive radial extracorporeal shockwave therapy combined with therapeutic exercise.
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Participants receive radial extracorporeal shockwave therapy combined with a structured therapeutic exercise program for management of piriformis syndrome.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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1. Pain Intensity
Délai: 1. Baseline, post-intervention (4 weeks), and 3-month follow-up
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1. Pain intensity will be assessed using the Visual Analog Scale (VAS), a 10-cm scale ranging from 0 (no pain) to 10 (worst imaginable pain).
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1. Baseline, post-intervention (4 weeks), and 3-month follow-up
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2. Hip Range of Motion
Délai: Baseline, post-intervention (4 weeks), and 3-month follow-up
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Hip joint range of motion will be measured in degrees using a standard universal goniometer.
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Baseline, post-intervention (4 weeks), and 3-month follow-up
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3. Quality of Life
Délai: Baseline, post-intervention (4 weeks), and 3-month follow-up
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Health-related quality of life will be assessed using the SF-36 questionnaire.
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Baseline, post-intervention (4 weeks), and 3-month follow-up
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Functional Disability
Délai: Baseline, post-intervention (4 weeks), and 3-month follow-up
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Functional disability will be evaluated using the Oswestry Disability Index (ODI), which measures disability related to low back and gluteal pain.
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Baseline, post-intervention (4 weeks), and 3-month follow-up
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Sahar M Abdelmutilibe, PHD, Faculty of Physical Therapy, Beni Suef University, Cairo, Egypt
Publications et liens utiles
Publications générales
- MF DEO, Johnson DS, Demchak T, Tomazoni SS, Leal-Junior EC. Low-intensity LASER and LED (photobiomodulation therapy) for pain control of the most common musculoskeletal conditions. Eur J Phys Rehabil Med. 2022;58(2):282-9.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
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
- La douleur
- Manifestations neurologiques
- Maladies du système nerveux
- Maladies neuromusculaires
- Maladies du système nerveux périphérique
- Névralgie
- Douleur pelvienne
- Mononeuropathies
- Syndromes de compression nerveuse
- Neuropathie sciatique
- Conditions pathologiques, signes et symptômes
- Signes et symptômes
- Syndrome du muscle piriforme
- Thérapeutique
- Modalités de physiothérapie
- Soins aux patients
- Réhabilitation
- Suivi
- Continuité des soins aux patients
- Thérapie au laser
- Photothérapie
- Thérapie d'exercice
- Thérapie lumineuse de bas niveau
Autres numéros d'identification d'étude
- FPTBSUREC/0212/15426 (Autre identifiant: Faculty of Physical Therapy, Beni Suef University)
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
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