An interventional study of Pain Neuroscience Education (PNE) and Graded Motor Imagery (GMI) in Diabetic Adhesive Capsulitis, Frozen Shoulder and Type II Diabetes Mellitus, sponsored by Riphah International University. Not yet recruiting at 2 sites in Pakistan. Open to participants aged 40 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-08-13.
Sponsored by Riphah International University · Not applicable, Interventional, and Treatment
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.
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.
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.
383 studies on the registry are indexed under Bursitis; 111 are open to participants now.
This study's planned enrollment of 50 is above the median of 44 across 346 interventional studies indexed under Bursitis.
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Exclusion Criteria:
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.
Behavioral: Pain Neuroscience Education (PNE) · Behavioral: Graded Motor Imagery (GMI) · Other: 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.
Other: Conventional Physiotherapy
Structured educational sessions designed to improve patients' understanding of pain neurophysiology, central sensitization, pain coping strategies, and self-management.
Also known as: 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.
Pain intensity measured by Numeric Pain Rating Scale (NPRS)
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".
Time frame: Baseline (Week 0), Week 3, and Week 6
Shoulder Pain and Disability Measured by the Shoulder Pain and Disability Index (SPADI).
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.
Time frame: Baseline (Week 0), Week 3, and Week 6
Shoulder Range of Motion Measured Using a Universal Goniometer
Active shoulder range of motion (flexion, abduction, internal rotation, and external rotation) will be measured using a universal goniometer.
Time frame: Baseline (Week 0), Week 3, and Week 6
Kinesiophobia Measured by the Tampa Scale of Kinesiophobia (TSK-17).
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.
Time frame: Baseline (Week 0), Week 3, and Week 6
Central Sensitization Measured by the Central Sensitization Inventory (CSI).
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.
Time frame: Baseline (Week 0), Week 3, and Week 6
Health-Related Quality of Life Measured by the 36-Item Short Form Health Survey (SF-36).
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.
Time frame: Baseline (Week 0), Week 3, and Week 6
Plan to share: No — 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.
Start is estimated for Aug 2026; primary completion for Jun 2027, 10 months later.
Of 217 non-industry interventional studies with no phase under Bursitis, half reached primary completion within 10 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 17. This study's planned 10 months is close to that.
Counting every sponsor, half of 217 studies reached it within 10 months; a quarter within 5 and three quarters within 17.
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This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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