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

NCT07763366 | Not Yet Recruiting

• 1 other identifier: Rasheeda
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

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.

Conditions

Diabetic Adhesive Capsulitis; Frozen Shoulder; Type II Diabetes Mellitus

Keywords

Diabetic Adhesive Capsulitis Frozen Shoulder Pain Neuroscience Education Graded Motor Imagery Conventional Physiotherapy Kinesiophobia Central Sensitization

Outcome Measures

Primary Outcomes (5)

• 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".

  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.

  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.

  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.

  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.

  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).

  Baseline (Week 0), Week 3, and Week 6

Study Arms (2)

Experimental Group (PNE + GMI + Conventional Physiotherapy)

EXPERIMENTAL

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

Control Group (Conventional Physiotherapy)

ACTIVE COMPARATOR

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

Interventions

Pain Neuroscience Education (PNE) BEHAVIORAL

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)

Experimental Group (PNE + GMI + Conventional Physiotherapy)

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.

Experimental Group (PNE + GMI + Conventional Physiotherapy)

Conventional Physiotherapy OTHER

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

Control Group (Conventional Physiotherapy); Experimental Group (PNE + GMI + Conventional Physiotherapy)

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Previous shoulder surgery
• History of fracture or dislocation of shoulder
• Cervical radiculopathy
• Neurological disorders
• Severe diabetic complications
• Cognitive impairments.

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (2)

RIPHAH International hospital Islamabad

Islamabad, Capital Territory, 44000, Pakistan

Location

IIMCT-Railway General Hospital

Rawalpindi, Punjab Province, 46000, Pakistan

Location

Related Publications (5)

• 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.

  PMID: 37344366 BACKGROUND

• 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.

  PMID: 40938441 BACKGROUND

• 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.

  PMID: 27351541 BACKGROUND

• 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.

  PMID: 29257926 BACKGROUND

• 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.

  PMID: 35354678 BACKGROUND

MeSH Terms

Conditions

Bursitis; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Huma Riaz

  Riphah International University, Islamabad

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rasheeda D/O Muhammad Bux, DPT

CONTACT

+92 308-8334013; rasheedarattar@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The outcome assessor will be kept blind in this trial.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 10, 2026
• First Posted: August 13, 2026
• Study Start (Estimated): August 15, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): July 31, 2027
• Last Updated: August 13, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

PA (2)