Pain Neuroscience Education and Graded Motor Imagery Combined With Conventional Physiotherapy on Diabetic Adhesive Capsulitis
10 août 2026 mis à jour par: Riphah International University
Effects of Pain Neuroscience Education and Graded Motor Imagery Combined With Conventional Physiotherapy on Pain, Kinesiophobia, and Functional Disability in Diabetic Adhesive Capsulitis
The purpose of this study is to determine the effects of Pain Neuroscience Education (PNE) and Graded Motor Imagery (GMI) combined with conventional physiotherapy on pain, kinesiophobia, central sensitization, functional disability, range of motion, and quality of life in patients with Type II diabetic adhesive capsulitis.
Adhesive capsulitis is a common musculoskeletal condition characterized by pain and progressive restriction of shoulder movement, particularly among individuals with diabetes mellitus.
Conventional physiotherapy is widely used to restore shoulder mobility and function; however, it may not adequately address central sensitization and fear of movement.
Pain Neuroscience Education aims to improve patients' understanding of pain mechanisms and reduce maladaptive beliefs, while Graded Motor Imagery targets cortical reorganization and movement-related fear.
The combination of these interventions with conventional physiotherapy may improve clinical outcomes and enhance quality of life.
Aperçu de l'étude
Statut
Pas encore de recrutement
Les conditions
Description détaillée
This study is a randomized controlled trial with a parallel-group design to evaluate the effectiveness of Pain Neuroscience Education (PNE) and Graded Motor Imagery (GMI) combined with conventional physiotherapy in patients with Type II diabetic adhesive capsulitis. A total of 50 participants meeting the inclusion and exclusion criteria will be recruited using a non-probability convenience sampling technique and randomly allocated into two groups.
- Experimental Group: Participants will receive Pain Neuroscience Education, Graded Motor Imagery, and conventional physiotherapy.
- Control Group: Participants will receive conventional physiotherapy alone. Both groups will undergo treatment for 6 weeks, with three treatment sessions per week. The experimental intervention will include weekly Pain Neuroscience Education sessions, progressive Graded Motor Imagery (laterality recognition, motor imagery, and mirror therapy), along with conventional physiotherapy consisting of joint mobilization, stretching, strengthening, range-of-motion exercises, and functional training.
Outcome assessments will be performed at baseline (Week 0), mid-treatment (Week 3), and post-treatment (Week 6). The primary outcome measures will include pain intensity (Numeric Pain Rating Scale), shoulder range of motion (Universal Goniometer), functional disability (Shoulder Pain and Disability Index), kinesiophobia (Tampa Scale of Kinesiophobia), and central sensitization (Central Sensitization Inventory). Quality of life will be assessed using the Short Form-36 (SF-36) questionnaire. The findings of this study will determine whether adding Pain Neuroscience Education and Graded Motor Imagery to conventional physiotherapy provides superior improvements in pain, psychological outcomes, functional ability, and quality of life compared with conventional physiotherapy alone.
Type d'étude
Interventionnel
Inscription (Estimé)
50
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Rasheeda D/O Muhammad Bux, DPT
- Numéro de téléphone: +92 308-8334013
- E-mail: rasheedarattar@gmail.com
Lieux d'étude
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Capital Territory
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Islamabad, Capital Territory, Pakistan, 44000
- RIPHAH International hospital Islamabad
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Contact:
- Dr. Mirza Obaid Baig Assistant professor/HOD Clinical Faculty of FRAHS Islamabad
- Numéro de téléphone: +92 333-2238706
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Punjab Province
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Rawalpindi, Punjab Province, Pakistan, 46000
- IIMCT-Railway General Hospital
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Contact:
- Dr. Mirza Obaid Baig Assistant Professor/HOD Clinical FRAHS
- Numéro de téléphone: +92 333-2238706
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Non
La description
Inclusion Criteria:
- Diagnosed cases of adhesive capsulitis (Stage I or II)
- Diagnosed with Type II Diabetes Mellitus
- Age between 40-65 years
- Shoulder pain lasting more than 3 months
- Limited shoulder range of motion.
Exclusion Criteria:
- Previous shoulder surgery
- History of fracture or dislocation of shoulder
- Cervical radiculopathy
- Neurological disorders
- Severe diabetic complications
- Cognitive impairments.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Experimental Group (PNE + GMI + Conventional Physiotherapy)
Participants assigned to the experimental group will receive Pain Neuroscience Education (PNE) and Graded Motor Imagery (GMI) combined with conventional physiotherapy.
The intervention will be delivered over 6 weeks, with three supervised treatment sessions per week.
Pain Neuroscience Education will address pain neurophysiology, central sensitization, fear-avoidance beliefs, coping strategies, and self-management.
Graded Motor Imagery will include laterality recognition, motor imagery, and mirror therapy, progressing according to the treatment protocol.
Conventional physiotherapy will consist of shoulder range-of-motion exercises, joint mobilization, stretching, strengthening, proprioceptive training, functional exercises, and activity-specific rehabilitation.
|
Structured educational sessions designed to improve patients' understanding of pain neurophysiology, central sensitization, pain coping strategies, and self-management.
Autres noms:
Progressive intervention consisting of laterality recognition, explicit motor imagery, and mirror therapy to improve cortical reorganization, reduce kinesiophobia, and restore shoulder function.
Conventional physiotherapy including shoulder range-of-motion exercises, stretching, joint mobilization, strengthening, proprioceptive training, scapular stabilization, and functional exercises.
|
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Comparateur actif: Control Group (Conventional Physiotherapy)
Participants assigned to the control group will receive conventional physiotherapy alone for 6 weeks, with three supervised treatment sessions per week.
Treatment will include pain relief modalities, shoulder range-of-motion exercises, stretching, joint mobilization, strengthening exercises, proprioceptive exercises, functional training, and activity-specific rehabilitation without Pain Neuroscience Education or Graded Motor Imagery.
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Conventional physiotherapy including shoulder range-of-motion exercises, stretching, joint mobilization, strengthening, proprioceptive training, scapular stabilization, and functional exercises.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Pain intensity measured by Numeric Pain Rating Scale (NPRS)
Délai: Baseline (Week 0), Week 3, and Week 6
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Pain intensity will be assessed using the Numeric Pain Rating Scale (NPRS).
The Numeric Pain Rating Scale (NPRS) is a self-reported outcome measure used to assess pain intensity in musculoskeletal and rehabilitation settings.
The scale ranges from 0 to 10, where 0 indicates "no pain" and 10 indicates "worst imaginable pain".
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Baseline (Week 0), Week 3, and Week 6
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Shoulder Pain and Disability Measured by the Shoulder Pain and Disability Index (SPADI).
Délai: Baseline (Week 0), Week 3, and Week 6
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Functional disability will be evaluated using the Shoulder Pain and Disability Index (SPADI).
The Shoulder Pain and Disability Index (SPADI) is a self-administered questionnaire developed to assess pain and functional disability associated with shoulder disorders, particularly adhesive capsulitis and other musculoskeletal shoulder conditions.
The SPADI consists of 13 items divided into two subscales: a pain subscale containing 5 items and a disability subscale containing 8 items.
Each item is scored using a numerical rating scale ranging from 0 to 10, where 0 represents "no pain" or "no difficulty" and 10 represents "worst pain imaginable".
Higher scores indicate greater pain and disability.
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Baseline (Week 0), Week 3, and Week 6
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Shoulder Range of Motion Measured Using a Universal Goniometer
Délai: Baseline (Week 0), Week 3, and Week 6
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Active shoulder range of motion (flexion, abduction, internal rotation, and external rotation) will be measured using a universal goniometer.
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Baseline (Week 0), Week 3, and Week 6
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Kinesiophobia Measured by the Tampa Scale of Kinesiophobia (TSK-17).
Délai: Baseline (Week 0), Week 3, and Week 6
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Kinesiophobia will be assessed using the Tampa Scale of Kinesiophobia (TSK-17).The Tampa Scale of Kinesiophobia (TSK) is a self-reported questionnaire used to assess fear of movement, fear of reinjury, and avoidance behaviors associated with pain and musculoskeletal disorders.The most commonly used version is the TSK-17, which consists of 17 items assessing beliefs related to physical activity and movement-related fear.
Each item is scored on a 4-point Likert scale ranging from 1 ("strongly disagree") to 4 ("strongly agree").
The total score ranges from 17 to 68, with higher scores indicating greater levels of kinesiophobia and fear-avoidance behavior.
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Baseline (Week 0), Week 3, and Week 6
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Central Sensitization Measured by the Central Sensitization Inventory (CSI).
Délai: Baseline (Week 0), Week 3, and Week 6
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Central sensitization will be assessed using the Central Sensitization Inventory (CSI).
The Central Sensitization Inventory (CSI) is a self-reported questionnaire developed to identify symptoms associated with central sensitization in individuals with chronic pain disorders.
The CSI consists of 25 items that assess health-related symptoms commonly associated with central sensitization syndromes.
Each item is scored on a 5-point Likert scale ranging from 0 ("never") to 4 ("always").
Higher scores indicate greater symptoms related to central sensitization.
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Baseline (Week 0), Week 3, and Week 6
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Health-Related Quality of Life Measured by the 36-Item Short Form Health Survey (SF-36).
Délai: Baseline (Week 0), Week 3, and Week 6
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The Short Form-36 (SF-36) is a widely used self-reported questionnaire designed to assess health-related quality of life in individuals with acute and chronic health conditions.
The SF-36 consists of 36 items divided into eight health domains: physical functioning, role limitations due to physical health, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, and mental health.
Each domain score is transformed into a scale ranging from 0 to 100, where higher scores indicate better health-related quality of life.
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Baseline (Week 0), Week 3, and Week 6
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: Huma Riaz, Riphah International University, Islamabad
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Publications générales
- Louw A, Zimney K, Puentedura EJ, Diener I. The efficacy of pain neuroscience education on musculoskeletal pain: A systematic review of the literature. Physiother Theory Pract. 2016 Jul;32(5):332-55. doi: 10.1080/09593985.2016.1194646. Epub 2016 Jun 28.
- Sawyer EE, McDevitt AW, Louw A, Puentedura EJ, Mintken PE. Use of Pain Neuroscience Education, Tactile Discrimination, and Graded Motor Imagery in an Individual With Frozen Shoulder. J Orthop Sports Phys Ther. 2018 Mar;48(3):174-184. doi: 10.2519/jospt.2018.7716. Epub 2017 Dec 19.
- Candiri B, Talu B, Guner E, Ozen M. The effect of graded motor imagery training on pain, functional performance, motor imagery skills, and kinesiophobia after total knee arthroplasty: randomized controlled trial. Korean J Pain. 2023 Jul 1;36(3):369-381. doi: 10.3344/kjp.23020. Epub 2023 Jun 22.
- Gurudut P, Godse AN. Effectiveness of graded motor imagery in subjects with frozen shoulder: a pilot randomized controlled trial. Korean J Pain. 2022 Apr 1;35(2):152-159. doi: 10.3344/kjp.2022.35.2.152.
- Schneider M. [Patients benefit from information : Pain neuroscience education in an outpatient setting]. Orthopadie (Heidelb). 2025 Nov;54(11):880-888. doi: 10.1007/s00132-025-04702-y. Epub 2025 Sep 12. German.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Estimé)
15 août 2026
Achèvement primaire (Estimé)
30 juin 2027
Achèvement de l'étude (Estimé)
31 juillet 2027
Dates d'inscription aux études
Première soumission
10 août 2026
Première soumission répondant aux critères de contrôle qualité
10 août 2026
Première publication (Réel)
13 août 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
13 août 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
10 août 2026
Dernière vérification
1 août 2026
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- Rasheeda
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
Description du régime IPD
Individual participant data (IPD) will not be shared because the data are confidential and were collected solely for the purposes of this research study.
Participant privacy and institutional policies will be maintained.
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
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 .