- ICH GCP
- Yhdysvaltain kliinisten tutkimusten rekisteri
- Kliininen tutkimus NCT07763366
Pain Neuroscience Education and Graded Motor Imagery Combined With Conventional Physiotherapy on Diabetic Adhesive Capsulitis
Effects of Pain Neuroscience Education and Graded Motor Imagery Combined With Conventional Physiotherapy on Pain, Kinesiophobia, and Functional Disability in Diabetic Adhesive Capsulitis
Tutkimuksen yleiskatsaus
Tila
Yksityiskohtainen kuvaus
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.
Opintotyyppi
Ilmoittautuminen (Arvioitu)
Vaihe
- Ei sovellettavissa
Yhteystiedot ja paikat
Opiskeluyhteys
- Nimi: Rasheeda D/O Muhammad Bux, DPT
- Puhelinnumero: +92 308-8334013
- Sähköposti: rasheedarattar@gmail.com
Opiskelupaikat
-
-
Capital Territory
-
Islamabad, Capital Territory, Pakistan, 44000
- RIPHAH International hospital Islamabad
-
Ottaa yhteyttä:
- Dr. Mirza Obaid Baig Assistant professor/HOD Clinical Faculty of FRAHS Islamabad
- Puhelinnumero: +92 333-2238706
-
-
Punjab Province
-
Rawalpindi, Punjab Province, Pakistan, 46000
- IIMCT-Railway General Hospital
-
Ottaa yhteyttä:
- Dr. Mirza Obaid Baig Assistant Professor/HOD Clinical FRAHS
- Puhelinnumero: +92 333-2238706
-
-
Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
- Aikuinen
- Vanhempi Aikuinen
Hyväksyy terveitä vapaaehtoisia
Kuvaus
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.
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Hoito
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Kaksinkertainen
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
|---|---|
|
Kokeellinen: 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.
Muut nimet:
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.
|
|
Active Comparator: 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.
|
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Pain intensity measured by Numeric Pain Rating Scale (NPRS)
Aikaikkuna: 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).
Aikaikkuna: 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
Aikaikkuna: 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).
Aikaikkuna: 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).
Aikaikkuna: 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
|
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Health-Related Quality of Life Measured by the 36-Item Short Form Health Survey (SF-36).
Aikaikkuna: 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
|
Yhteistyökumppanit ja tutkijat
Sponsori
Tutkijat
- Päätutkija: Huma Riaz, Riphah International University, Islamabad
Julkaisuja ja hyödyllisiä linkkejä
Yleiset julkaisut
- 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.
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Arvioitu)
Ensisijainen valmistuminen (Arvioitu)
Opintojen valmistuminen (Arvioitu)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- Rasheeda
Yksittäisten osallistujien tietojen suunnitelma (IPD)
Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?
IPD-suunnitelman kuvaus
Lääke- ja laitetiedot, tutkimusasiakirjat
Tutkii yhdysvaltalaista FDA sääntelemää lääkevalmistetta
Tutkii yhdysvaltalaista FDA sääntelemää laitetuotetta
Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .