Pain Neuroscience Education and Graded Motor Imagery Combined With Conventional Physiotherapy on Diabetic Adhesive Capsulitis
2026년 8월 10일 업데이트: 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.
연구 개요
상태
아직 모집하지 않음
상세 설명
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.
연구 유형
중재적
등록 (추정된)
50
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Rasheeda D/O Muhammad Bux, DPT
- 전화번호: +92 308-8334013
- 이메일: rasheedarattar@gmail.com
연구 장소
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Capital Territory
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Islamabad, Capital Territory, 파키스탄, 44000
- RIPHAH International hospital Islamabad
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연락하다:
- Dr. Mirza Obaid Baig Assistant professor/HOD Clinical Faculty of FRAHS Islamabad
- 전화번호: +92 333-2238706
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Punjab Province
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Rawalpindi, Punjab Province, 파키스탄, 46000
- IIMCT-Railway General Hospital
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연락하다:
- Dr. Mirza Obaid Baig Assistant Professor/HOD Clinical FRAHS
- 전화번호: +92 333-2238706
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
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.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 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.
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Structured educational sessions designed to improve patients' understanding of pain neurophysiology, central sensitization, pain coping strategies, and self-management.
다른 이름들:
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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활성 비교기: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Pain intensity measured by Numeric Pain Rating Scale (NPRS)
기간: 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).
기간: 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
기간: 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).
기간: 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).
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Health-Related Quality of Life Measured by the 36-Item Short Form Health Survey (SF-36).
기간: 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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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Huma Riaz, Riphah International University, Islamabad
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
- 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.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
2026년 8월 15일
기본 완료 (추정된)
2027년 6월 30일
연구 완료 (추정된)
2027년 7월 31일
연구 등록 날짜
최초 제출
2026년 8월 10일
QC 기준을 충족하는 최초 제출
2026년 8월 10일
처음 게시됨 (실제)
2026년 8월 13일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 8월 13일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 8월 10일
마지막으로 확인됨
2026년 8월 1일
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- Rasheeda
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니요
IPD 계획 설명
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.
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아니
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아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .