- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT03511404
Clinical Electrophysiology Assessment for Low Back Pain (LBP)
Clinical Electrophysiology Assessment for Rehabilitation Progress of Low Back Pain Patients
Non specific chronic low back pain (LBP) is a debilitating disorder characterized by tremendous personal and socioeconomic impact, with long-term sick leave, low quality of life, and very high financial costs. Evidence suggests that patients with non specific LBP presented with altered muscle activity pattern when compare with healthy people. It has been reviewed that exercise therapy was effective for modulation of muscle dysfunction in chronic low back pain. However, there is a lack of objective assessment of the pain relief in low back pain rehabilitation. Clinical application of surface electromyography (EMG) may provide a quantitative and objective tool to evaluate the rehabilitation outcome in patients with non specific chronic low back pain before and after treatment.
Objectives: To verify the usefulness of surface electromyography (EMG) in low back pain (LBP) rehabilitation assessment.
Setting: Out-patient physiotherapy musculoskeletal rehabilitation
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Participants: One hundred adults with non specific chronic low back pain (LBP) will be recruited.
Methodology: A prospective correlation study between clinical examination and electrophysiology assessment. This project will perform carefully with a definitive chronic low back pain (LBP). Firstly, we will compare the surface EMG features from patients with LBP to normal data. In addition, the changes in electrophysiology assessment will be compared with clinical assessment by Numeric Pain Rating Scale (NPRS). This allows us to verify the potential clinical application of surface EMG features in physiotherapy progress assessment.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Guangdong
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Zhuhai, Guangdong, Chine, 519085
- Electromyography (EMG)system
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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:
- One hundred persons with non specific low back pain will be recruited consecutively from the Specialist Outpatient Department (SOPD) of Physiotherapy Department of Queen Elizabeth Hospital. Subjects will be included in the study if they presented with symptom duration of greater than three months with no radiological abnormality detected.
Exclusion Criteria:
- All subjects should be able to provide informed consent and demonstrate sufficient ability to tolerate the experiment procedure to avoid aggravation of symptoms during the experiment procedures. Subjects will be excluded if they have any major orthopedic, neurological, circulatory or respiratory conditions, a history or family history of epilepsy, recent or current pregnancies, and previous surgery to the abdomen or back. The back pain history in the previous year will be documented for those eligible subjects.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Diagnostique
- Modèle interventionnel: Affectation séquentielle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Expérimental: Chronical LBP
Patients with chronic low back pain to be measured with Numeric Pain Rating Scale (NPRS).
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All subjects will receive a course of conventional physiotherapy that incorporating components of pain relief and functional restoration with the use of electrotherapy and exercise therapy for twelve sessions twice weekly in six weeks guided by a registered physiotherapist in Hong Kong.
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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 on enrollment and after six weeks physiotherapy
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Intensity of self-reported pain was measured using a Numeric Pain Rating Scale (NPRS) anchored with 'no pain' at 0 and 'worst pain imaginable' at 10. Subjects rated their average pain over the preceding month prior to motor training, and rated their average pain across the final week of motor training.
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Baseline on enrollment and after six weeks physiotherapy
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
surface electromyography (EMG)
Délai: Baseline on enrollment and after six weeks physiotherapy
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Disposable surface EMG electrodes will be attached in array to the right and left lumbar erector spinae (LES) muscles, approximately 2 cm lateral to the L3 spinous process.
Root mean square amplitude of surface EMG measured was calculated and flexion-relaxation ratio in sitting was formulated by dividing the average surface EMG activity in upright sitting by the average surface EMG activity in slumped sitting.
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Baseline on enrollment and after six weeks physiotherapy
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Collaborateurs et enquêteurs
Parrainer
Collaborateurs
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
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 15-0132
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
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