このページは自動翻訳されたものであり、翻訳の正確性は保証されていません。を参照してください。 英語版 ソーステキスト用。

Pain Neuroscience Education and Graded Motor Imagery Combined With Conventional Physiotherapy on Diabetic Adhesive Capsulitis

2026年8月10日 更新者: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.

調査の概要

詳細な説明

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.

研究の種類

介入

入学 (推定)

50

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究場所

    • Capital Territory
      • Islamabad、Capital Territory、パキスタン、44000
        • RIPHAH International hospital Islamabad
        • コンタクト:
          • Dr. Mirza Obaid Baig Assistant professor/HOD Clinical Faculty of FRAHS Islamabad
          • 電話番号:+92 333-2238706
    • Punjab Province
      • Rawalpindi、Punjab Province、パキスタン、46000
        • IIMCT-Railway General Hospital
        • コンタクト:
          • Dr. Mirza Obaid Baig Assistant Professor/HOD Clinical FRAHS
          • 電話番号:+92 333-2238706

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:処理
  • 割り当て:ランダム化
  • 介入モデル:並列代入
  • マスキング:ダブル

武器と介入

参加者グループ / アーム
介入・治療
実験的: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.
他の名前:
  • Arm/group, experimental (PNE)
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.
アクティブコンパレータ: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.

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Pain intensity measured by Numeric Pain Rating Scale (NPRS)
時間枠: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).
時間枠: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
時間枠: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).
時間枠: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).
時間枠: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

二次結果の測定

結果測定
メジャーの説明
時間枠
Health-Related Quality of Life Measured by the 36-Item Short Form Health Survey (SF-36).
時間枠: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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

捜査官

  • 主任研究者:Huma Riaz、Riphah International University, Islamabad

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年8月15日

一次修了 (推定)

2027年6月30日

研究の完了 (推定)

2027年7月31日

試験登録日

最初に提出

2026年8月10日

QC基準を満たした最初の提出物

2026年8月10日

最初の投稿 (実際)

2026年8月13日

学習記録の更新

投稿された最後の更新 (実際)

2026年8月13日

QC基準を満たした最後の更新が送信されました

2026年8月10日

最終確認日

2026年8月1日

詳しくは

本研究に関する用語

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

IPD プランの説明

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.

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

購読する