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CTRI Number  CTRI/2025/02/080055 [Registered on: 07/02/2025] Trial Registered Prospectively
Last Modified On: 30/01/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Other (Specify) [Nerve block]  
Study Design  Non-randomized, Placebo Controlled Trial 
Public Title of Study   Repeated suprascapular nerve block in hemiplegic shoulder pain in reducing shoulder pain and improving range of motion 
Scientific Title of Study   Repeated suprascapular nerve block in hemiplegic shoulder pain in reducing shoulder pain and improving range of motion: a randomized controlled trial 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Longjam Darendrajit Singh 
Designation  Assistant Professor 
Affiliation  Shija Academy of Health Sciences 
Address  Department of PMR Shija Academy of Health Sciences Langol

Imphal West
MANIPUR
795004
India 
Phone  9856255474  
Fax    
Email  darendrajit4u@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Longjam Darendrajit Singh 
Designation  Assistant Professor 
Affiliation  Shija Academy of Health Sciences 
Address  Department of PMR Shija Academy of Health Sciences Langol

Imphal West
MANIPUR
795004
India 
Phone  9856255474  
Fax    
Email  darendrajit4u@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Longjam Darendrajit Singh 
Designation  Assistant Professor 
Affiliation  Shija Academy of Health Sciences 
Address  Department of PMR Shija Academy of Health Sciences Langol

Imphal West
MANIPUR
795004
India 
Phone  9856255474  
Fax    
Email  darendrajit4u@gmail.com  
 
Source of Monetary or Material Support  
Shija Academy of Health Sciences Langol, Imphal West District Pin no. 795004 Manipur, India 
 
Primary Sponsor  
Name  Shija Academy of Health Sciences 
Address  Langol, Imphal West Pin-795004 Manipur 
Type of Sponsor  Private medical college 
 
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 
Dr Longjam Darendrajit Singh  Shija Academy of Health Sciences  Department of Physical Medicine and Rehabilitaion, B-Block, Ground Floor, Langol, Imphal West Pin 795004 Manipur India
Imphal West
MANIPUR 		 9856255474

darendrajit4u@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, SAHS  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M958||Other specified acquired deformities of musculoskeletal system,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Supracapular nerve block (with normal saline)  Repeated suprascapular nerve block with 2 ml of Inj. Normal saline (0.9%). Nerve block will be performed 15mins before the rehabilitation program, twice a day for 5 days  
Intervention  Suprascapular nerve block (with xylocaine)  Repeated suprascapular nerve block with 2 ml of Inj. Lignocaine (1%). Nerve block will be performed 15mins before the rehabilitation program, twice a day for 5 days 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Age: 18-80 years
MRI confirmed stroke within the previous 12 months with hemiplegic shoulder pain
Patients willing to provide informed consent 
 
ExclusionCriteria 
Details  Patient who have history of shoulder pain on the same side before stroke
Who have taken any form of interventional treatment for the shoulder pain
Patient with uncontrolled diabetes, ischemic heart disease, cardiac arrhythmia or a pacemaker, hepatitis 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
1. Range of Motion (ROM) of the shoulder joint
2. Pain 		 30 minutes, 1 week, 2 weeks and 4 weeks after the 1st nerve block 
 
Secondary Outcome  
Outcome  TimePoints 
Nil   
 
Target Sample Size   Total Sample Size="66"
Sample Size from India="66" 
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   Phase 3 
Date of First Enrollment (India)   16/02/2025 
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)   Open to Recruitment 
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [darendrajit4u@gmail.com].

  6. For how long will this data be available start date provided 27-06-2025 and end date provided 30-06-2030?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - Nil
Brief Summary   This study is being conducted with an aim to study the efficacy of repeated suprascapular nerve block in reducing pain and improvement in range of motion of shoulder joint in hemilegic shoulder joint pain. 
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