- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07617623
Effects of Telerehabilitation and Supervised Clinic Based Rehab With Pain Neuroscience Education for Pain,Kinesiophobia and Functional Disability Among Chronic Non-Specific Neck Pain Patients
Chronic non-specific neck pain is a common musculoskeletal condition affecting a large proportion of the population worldwide. It is characterized by persistent neck pain lasting more than three months without a specific underlying pathology. Many patients experience ongoing symptoms such as pain, reduced range of motion, functional limitations, and psychological factors like kinesiophobia, which can negatively affect recovery and quality of life.
Conventional physiotherapy, including supervised clinic-based rehabilitation, is widely used for the management of chronic non-specific neck pain. These programs typically involve exercise therapy and patient education; however, access to regular in-clinic treatment can be limited due to factors such as travel, cost, and time constraints.
Telerehabilitation has emerged as an alternative approach that allows delivery of physiotherapy services through online platforms, improving accessibility and convenience for patients. In addition, pain neuroscience education (PNE) is an evidence-based strategy that helps patients understand pain mechanisms, reduce fear-avoidance behaviors, and improve treatment outcomes when combined with exercise therapy.
Although both telerehabilitation and supervised clinic-based rehabilitation are effective, there is limited evidence directly comparing these two approaches when combined with standardized pain neuroscience education.
Therefore, this randomized controlled trial aims to compare the effects of telerehabilitation with pain neuroscience education and supervised clinic-based rehabilitation with pain neuroscience education on pain intensity, functional disability, and kinesiophobia in individuals with chronic non-specific neck pain.
Aperçu de l'étude
Statut
Les conditions
Description détaillée
Chronic non-specific neck pain is a highly prevalent musculoskeletal condition characterized by persistent pain in the cervical region without a specific identifiable pathology. It is a major contributor to disability worldwide and is commonly associated with physical impairments such as reduced cervical mobility, muscle dysfunction, and postural alterations. In addition to physical limitations, psychological factors such as fear of movement (kinesiophobia) and maladaptive pain beliefs play a significant role in the persistence of symptoms and delayed recovery.
Conventional management of chronic non-specific neck pain primarily involves supervised clinic-based physiotherapy, including therapeutic exercises and patient education. While these approaches are effective, their implementation may be limited by barriers such as accessibility, travel requirements, cost, and time constraints, particularly in low-resource settings.
Telerehabilitation has emerged as an alternative mode of delivering physiotherapy services using digital platforms. It allows remote supervision, guidance, and monitoring of patients, thereby improving accessibility and convenience. Current evidence suggests that telerehabilitation may provide comparable outcomes to face-to-face rehabilitation in musculoskeletal conditions; however, variability in treatment protocols and limited high-quality comparative studies restrict definitive conclusions.
Pain neuroscience education (PNE) is an evidence-based educational approach that aims to improve patients' understanding of pain by explaining underlying neurophysiological mechanisms, including central sensitization. It helps reduce fear-avoidance behaviors, correct maladaptive beliefs, and enhance patient engagement in rehabilitation. When combined with exercise therapy, PNE has demonstrated beneficial effects on both physical and psychological outcomes in individuals with chronic pain.
Despite the growing use of telerehabilitation and the recognized benefits of integrating PNE into rehabilitation programs, there is limited evidence directly comparing telerehabilitation and supervised clinic-based rehabilitation when both interventions are delivered with standardized PNE content.
This study is designed as a randomized controlled trial to compare two modes of intervention delivery: telerehabilitation with pain neuroscience education and supervised clinic-based rehabilitation with pain neuroscience education. Both groups will receive a structured program consisting of therapeutic exercises targeting cervical and scapular musculature along with standardized PNE sessions. The interventions will be delivered over a defined period, with the primary distinction being the mode of delivery (remote versus in-person supervision).
The study aims to evaluate whether telerehabilitation can achieve outcomes comparable to supervised clinic-based rehabilitation when both are combined with pain neuroscience education. By addressing both physical and psychological aspects of chronic pain, this study adopts a biopsychosocial approach to management.
The findings of this study are expected to contribute to evidence-based physiotherapy practice by identifying an effective and accessible mode of delivering rehabilitation for individuals with chronic non-specific neck pain, particularly in settings where access to in-person care is limited.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Dr Shoaib Waqas, Phd
- Numéro de téléphone: +92 302 4552109
- E-mail: shoaib.waqas@ubas.edu.pk
Lieux d'étude
-
-
-
Lahore, Pakistan, 54000
- Recrutement
- Saleem Memorial Hospital Lahore
-
Contact:
- Dr Ahmed Shoaib, Mbbs,FRCS
- Numéro de téléphone: +923030007321
- E-mail: Ahmed.Shoaib@smth.pk
-
Chercheur principal:
- Neha Khan, Dpt,MSPT
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
Accepte les volontaires sains
La description
Inclusion Criteria:
- Age between 18-40 years of both male and female gender.
- Currently suffering from neck pain & bilateral neck pain for at least three months.
- Moderate pain intensity (30mm to 70mm) on Visual Analogue Scale .
- Access & knowledge of mobile phone and internet use .
Exclusion Criteria:
- Any previous neck surgery or cervical trauma .
- Fibromyalgia & Myelopathy .
- Spinal deformities like thoracic hyper kyphosis or scoliosis .
- Cervical radiculopathy ,vertigo, cancer & vertebral fractures.
- Infection or inflammatory arthritis in cervical spine .
- History of the whiplash injury .
- Physiotherapeutic treatment in the last six months .
- Cognitive disorder that prohibited the pain neuroscience education intervention from being followed .
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: Telerehabilitation with Pain Neuroscience Education
Participants will receive a structured rehabilitation program delivered via online platforms.
The intervention includes therapeutic exercises targeting cervical and scapular muscles along with pain neuroscience education.
Sessions will be conducted three times per week for six weeks under remote supervision.
|
A remotely delivered physical therapy program including stretching and strengthening exercises for cervical and scapular muscles combined with pain neuroscience education, delivered via online platforms three times per week for six weeks.
|
|
Comparateur actif: Supervised Clinic Based Rehab with Pain Neuroscience Education
Participants will receive supervised face-to-face physiotherapy in a clinical setting.
The intervention includes the same therapeutic exercises and pain neuroscience education as the experimental group, delivered under direct supervision of a physiotherapist.
Sessions will be conducted three times per week for six weeks.
|
A clinic-based physiotherapy program including stretching and strengthening exercises for cervical and scapular muscles combined with pain neuroscience education, delivered under direct supervision three times per week for six weeks.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Numeric Pain Rating Scale for Pain Intensity (NPRS)
Délai: 6 weeks
|
Pain intensity will be assessed using the Numeric Pain Rating Scale (NPRS), an 11-point self-reported scale ranging from 0 (no pain) to 10 (worst imaginable pain).
The NPRS is a valid, reliable, and responsive tool commonly used to evaluate pain intensity in individuals with neck pain.
|
6 weeks
|
|
Neck Disability Index for Functional Disability (NDI)
Délai: 6 weeks
|
Functional disability will be assessed using the Neck Disability Index (NDI), a self-reported questionnaire consisting of 10 items related to daily activities, including pain intensity, personal care, lifting, reading, concentration, headache, work, driving, sleeping, and recreation.
Each item is scored from 0 to 5, with total scores ranging from 0 to 50.
Higher scores indicate greater disability.
|
6 weeks
|
|
Tampa Scale of Kinesiophobia (TSK-11)
Délai: 6 weeks
|
Kinesiophobia will be assessed using the 11-item Tampa Scale of Kinesiophobia (TSK-11).
Each item is scored on a 4-point Likert scale ranging from 1 (strongly disagree) to 4 (strongly agree), with total scores ranging from 11 to 44.
Higher scores indicate greater fear of movement and reinjury.
|
6 weeks
|
Collaborateurs et enquêteurs
Les enquêteurs
- Directeur d'études: Dr Shoaib Waqas, Phd, Lahore University of Biological and Applied Sciences
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
Termes MeSH pertinents supplémentaires
- Les troubles mentaux
- Troubles phobiques
- Troubles anxieux
- Kinésiophobie
- Administration des services de santé
- Prestation de soins de santé
- Thérapeutique
- Soins aux patients
- Services de santé
- Conseils de soins de santé
- Réhabilitation
- Suivi
- Continuité des soins aux patients
- Télémédecine
- Gestion des soins aux patients
- Téléréalité
Autres numéros d'identification d'étude
- UBAS/ERB/26/04/027
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 .