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CTRI Number  CTRI/2025/08/092987 [Registered on: 13/08/2025] Trial Registered Prospectively
Last Modified On: 09/10/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Effect of mental and movement exercises in relieving shoulder pain in patients with lower extremity paralysis 
Scientific Title of Study   Effectiveness of graded motor imagery in paraplegics with chronic shoulder pain. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Supriyantu Nisha 
Designation  Post graduate student (Masters of Physiotherapy) 
Affiliation  Indian Spinal Injuries Centre Institute Of Rehabilitation Sciences 
Address  Opp. Vasant Valley School, IAA Colony, Sector C, Vasant Kunj, New Delhi, Delhi 110070
Opp. Vasant Valley School, IAA Colony, Sector C, Vasant Kunj, New Delhi, Delhi 110070
South
DELHI
110070
India 
Phone  8860934760  
Fax    
Email  supriyantu.nisha@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Meena Makhija 
Designation  Associate Professor 
Affiliation  Indian Spinal Injuries Centre Institute Of Rehabilitation Sciences 
Address  Opp. Vasant Valley School, IAA Colony, Sector C, Vasant Kunj, New Delhi, Delhi 110070
Opp. Vasant Valley School, IAA Colony, Sector C, Vasant Kunj, New Delhi, Delhi 110070
South
DELHI
110070
India 
Phone  9910011816  
Fax    
Email  makhijameena81@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Supriyantu Nisha 
Designation  Postgraduate Student (Masters of Physiotherapy) 
Affiliation  Indian Spinal Injuries Centre Institute of Rehabilitation Sciences 
Address  Opp. Vasant Valley School, IAA Colony, Sector C, Vasant Kunj, New Delhi, Delhi 110070
Opp. Vasant Valley School, IAA Colony, Sector C, Vasant Kunj, New Delhi, Delhi 110070
South
DELHI
110070
India 
Phone  8860934760  
Fax    
Email  supriyantu.nisha@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Indian Spinal Injuries Centre Institute Of Rehabilitation Sciences 
Address  Opp. Vasant Valley School, IAA Colony, Sector C, Vasant Kunj, New Delhi, Delhi 110070 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Supriyantu Nisha  Indian Spinal Injury Centre - Institute of Rehabilitation Sciences  Opp. Vasant Valley School, IAA Colony, Sector C, Vasant Kunj, New Delhi, Delhi 110070
South
DELHI 
8860934760

supriyantu.nisha@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE ECR/96/Inst/DL/2013/RR-24  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G822||Paraplegia,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Control Group  CONTROL GROUP will receive Conventional physical therapy with relaxation therapy. It will be conducted for 40 minutes per session, three times a week for three weeks. 
Intervention  GRADED MOTOR IMAGERY GROUP  Graded Motor Imagery Group will receive Conventional physical therapy and Graded Motor Imagery Intervention (lateralization, motor imagery and mirror therapy). The intervention will be conducted for 40 minutes per session, three times a week for three weeks.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Age- 18-60 years
Diagnosed with Paraplegia (injury level T2 –T12)
Intermittent chronic shoulder pain lasting for minimum 1 month
Moderate pain (VAS scoring 4-7) 
 
ExclusionCriteria 
Details  History of acute trauma, previous surgery, fracture in the affected shoulder.
Diagnosed with rheumatoid arthritis or any other inflammatory disorder of the joints.
Diagnosed with adhesive capsulitis, glenohumeral instability.
Subjects who were on oral analgesics or any pain-relieving medications.
Cognitive impairment
Non-cooperative 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Shoulder Pain
Active range of motion (AROM) of shoulder
Disability of shoulder 
Baseline assessment (week 0)
Post intervention (week 3) 
 
Secondary Outcome  
Outcome  TimePoints 
Kinesiophobia
Pain Catastrophization 
Baseline assessment (week 0)
Post intervention (week 3) 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/09/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary
Modification(s)  

People with Spinal Cord Injury (SCI) using manual wheelchairs (MWC) have a greater reliance on their upper limbs to maintain their level of independence through daily activities, such as wheelchair propulsion and transfer which may result in shoulder pain. Shoulder pain in this population significantly affects independence and quality of life. Past literature suggests musculoskeletal pain is strongly associated with behaviors of pain catastrophizing and kinesiophobia.

Graded motor imagery (GMI) is a movement representation technique proven to be effective in various neurological and orthopaedic conditions, consisting three stages- implicit motor imagery (lateralization), explicit motor imagery, and mirror therapy which helps in cortical remapping that in turn reduces fear avoidance behavior, thus reducing pain.

OBJECTIVES

Primary objectives

To determine the effect of Graded Motor Imagery on pain reduction.

To determine the effect of Graded Motor Imagery on active range of motion (AROM) of shoulder.

To determine the effect of Graded Motor Imagery on disability of shoulder.

Secondary objectives

To determine the effect of Graded Motor Imagery on kinesiophobia.

To determine the effect of Graded Motor Imagery on Pain Catastrophization.

HYPOTHESIS

Null Hypothesis Ho-

       There will be no significant difference between GMI with conventional treatment as compared to conventional treatment alone on pain reduction, AROM, disability, kinesiophobia and catastrophization in paraplegics with Shoulder pain.

Alternate Hypothesis H1-

       There will be a significant difference between GMI with conventional treatment as compared to conventional treatment alone on pain reduction, AROM, disability, kinesiophobia and catastrophization in paraplegics with Shoulder pain.

 

Material and Methods

This randomized controlled trial will be conducted on paraplegic patients experiencing chronic shoulder pain, recruited from the Indian Spinal Injury Centre, New Delhi. A total of 30 participants (15 in each group) will be included based on strict inclusion and exclusion criteria. Eligible individuals will be aged 18–60 years, diagnosed with paraplegia (T2–T12 level), and suffering from moderate shoulder pain (VAS-4 to 7) for minimum 1 month. Participants with history of trauma or surgery, diagnosed with inflammatory disorders, adhesive capsulitis and joint instability, analgesic use, or cognitive issues will be excluded.

Baseline assessments will cover pain (Wheelchair User’s Shoulder Pain Index -WUSPI), AROM (goniometry), disability (Disability of the Arm, Shoulder, and Hand scale -DASH), kinesiophobia (Fear avoidance belief questionnaire-FABQ), and pain catastrophization (Pain Catastrophizing Scale-PCS). Participants will be randomly assigned into a control group (conventional physical therapy) and an experimental group (conventional therapy + GMI). The intervention will be conducted for 40 minutes per session, three times a week for three weeks. Post-intervention assessments will follow the same outcome measures.

Statistical Analysis Plan:

Data will be analysed using SPSS v21.0. Normality will be tested with the Shapiro-Wilk test. Paired t-test or Wilcoxon test will be used for within-group comparisons, and independent t-test or Mann–Whitney U test for between-group comparisons.


 
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