Diabetic Adhesive Capsulitis, Frozen Shoulder, Type II Diabetes Mellitus
Conditions
Keywords
Diabetic Adhesive Capsulitis Frozen Shoulder Pain Neuroscience Education Graded Motor Imagery Conventional Physiotherapy Kinesiophobia Central Sensitization
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALPain Neuroscience Education (PNE)
Structured educational sessions designed to improve patients' understanding of pain neurophysiology, central sensitization, pain coping strategies, and self-management.
BEHAVIORALGraded Motor Imagery (GMI)
Progressive intervention consisting of laterality recognition, explicit motor imagery, and mirror therapy to improve cortical reorganization, reduce kinesiophobia, and restore shoulder function.
OTHERConventional Physiotherapy
Conventional physiotherapy including shoulder range-of-motion exercises, stretching, joint mobilization, strengthening, proprioceptive training, scapular stabilization, and functional exercises.
Sponsors
Riphah International University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
The outcome assessor will be kept blind in this trial.
Intervention model description
Participants who meet the eligibility criteria will be randomly assigned in a 1:1 ratio to one of two parallel groups. The experimental group will receive Pain Neuroscience Education (PNE) and Graded Motor Imagery (GMI) combined with conventional physiotherapy, while the control group will receive conventional physiotherapy alone. Both groups will undergo supervised treatment sessions three times per week for six weeks. Outcome measures will be assessed at baseline (Week 0), mid-treatment (Week 3), and post-treatment (Week 6) to compare changes in pain intensity, shoulder range of motion, kinesiophobia, central sensitization, functional disability, and quality of life between the two groups.
Eligibility
Sex/Gender
ALL
Age
40 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain intensity measured by Numeric Pain Rating Scale (NPRS) | 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". |
| Shoulder Pain and Disability Measured by the Shoulder Pain and Disability Index (SPADI). | 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. |
| Shoulder Range of Motion Measured Using a Universal Goniometer | 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. |
| Kinesiophobia Measured by the Tampa Scale of Kinesiophobia (TSK-17). | 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. |
| Central Sensitization Measured by the Central Sensitization Inventory (CSI). | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Health-Related Quality of Life Measured by the 36-Item Short Form Health Survey (SF-36). | 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. |
Countries
Pakistan
Contacts
CONTACTRasheeda D/O Muhammad Bux, DPT
PRINCIPAL_INVESTIGATORHuma Riaz
Riphah International University, Islamabad
Outcome results
None listed