Pain Neuroscience Education and Graded Motor Imagery Combined With Conventional Physiotherapy on Diabetic Adhesive Capsulitis
10 de agosto de 2026 actualizado por: 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.
Descripción general del estudio
Estado
Aún no reclutando
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Intervencionista
Inscripción (Estimado)
50
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Rasheeda D/O Muhammad Bux, DPT
- Número de teléfono: +92 308-8334013
- Correo electrónico: rasheedarattar@gmail.com
Ubicaciones de estudio
-
-
Capital Territory
-
Islamabad, Capital Territory, Pakistán, 44000
- RIPHAH International hospital Islamabad
-
Contacto:
- Dr. Mirza Obaid Baig Assistant professor/HOD Clinical Faculty of FRAHS Islamabad
- Número de teléfono: +92 333-2238706
-
-
Punjab Province
-
Rawalpindi, Punjab Province, Pakistán, 46000
- IIMCT-Railway General Hospital
-
Contacto:
- Dr. Mirza Obaid Baig Assistant Professor/HOD Clinical FRAHS
- Número de teléfono: +92 333-2238706
-
-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
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 de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: 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.
Otros nombres:
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.
|
|
Comparador activo: 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.
|
Conventional physiotherapy including shoulder range-of-motion exercises, stretching, joint mobilization, strengthening, proprioceptive training, scapular stabilization, and functional exercises.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Pain intensity measured by Numeric Pain Rating Scale (NPRS)
Periodo de tiempo: Baseline (Week 0), Week 3, and Week 6
|
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".
|
Baseline (Week 0), Week 3, and Week 6
|
|
Shoulder Pain and Disability Measured by the Shoulder Pain and Disability Index (SPADI).
Periodo de tiempo: Baseline (Week 0), Week 3, and Week 6
|
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.
|
Baseline (Week 0), Week 3, and Week 6
|
|
Shoulder Range of Motion Measured Using a Universal Goniometer
Periodo de tiempo: Baseline (Week 0), Week 3, and Week 6
|
Active shoulder range of motion (flexion, abduction, internal rotation, and external rotation) will be measured using a universal goniometer.
|
Baseline (Week 0), Week 3, and Week 6
|
|
Kinesiophobia Measured by the Tampa Scale of Kinesiophobia (TSK-17).
Periodo de tiempo: Baseline (Week 0), Week 3, and Week 6
|
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.
|
Baseline (Week 0), Week 3, and Week 6
|
|
Central Sensitization Measured by the Central Sensitization Inventory (CSI).
Periodo de tiempo: Baseline (Week 0), Week 3, and Week 6
|
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.
|
Baseline (Week 0), Week 3, and Week 6
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Health-Related Quality of Life Measured by the 36-Item Short Form Health Survey (SF-36).
Periodo de tiempo: Baseline (Week 0), Week 3, and Week 6
|
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.
|
Baseline (Week 0), Week 3, and Week 6
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Huma Riaz, Riphah International University, Islamabad
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- 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.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
15 de agosto de 2026
Finalización primaria (Estimado)
30 de junio de 2027
Finalización del estudio (Estimado)
31 de julio de 2027
Fechas de registro del estudio
Enviado por primera vez
10 de agosto de 2026
Primero enviado que cumplió con los criterios de control de calidad
10 de agosto de 2026
Publicado por primera vez (Actual)
13 de agosto de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
13 de agosto de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
10 de agosto de 2026
Última verificación
1 de agosto de 2026
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- Rasheeda
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Descripción del plan 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.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .