| 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
|
|
|
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
|
|
|
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 |
|
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Regulatory Clearance Status from DCGI
|
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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 |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Centralized |
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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) |
|
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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 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. |