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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-65
SponsorRiphah International University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Previous shoulder surgery

History of fracture or dislocation of shoulder

Cervical radiculopathy

Neurological disorders

Trial design

Design model

Parallel

Treatments tested in this trial

  • Pain Neuroscience Education (PNE)

    Behavioral

    Structured educational sessions designed to improve patients' understanding of pain neurophysiology, central sensitization, pain coping strategies, and self-management.

  • Graded Motor Imagery (GMI)

    Behavioral

    Progressive intervention consisting of laterality recognition, explicit motor imagery, and mirror therapy to improve cortical reorganization, reduce kinesiophobia, and restore shoulder function.

  • Conventional Physiotherapy

    Other intervention

    Conventional physiotherapy including shoulder range-of-motion exercises, stretching, joint mobilization, strengthening, proprioceptive training, scapular stabilization, and functional exercises.

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Experimental Group (PNE + GMI + Conventional Physiotherapy)Experimental treatment 3 interventions
Group B: Control Group (Conventional Physiotherapy)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

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
2

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
3

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
4

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

Secondary outcomes

1

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

Other outcomes

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