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CTRI Number  CTRI/2025/11/097257 [Registered on: 11/11/2025] Trial Registered Prospectively
Last Modified On: 11/11/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia
Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Pain and Functional Improvement in Cases of Frozen Shoulder by Nerve block Or Shoulder Joint Injection 
Scientific Title of Study   Efficacy between Suprascapular Nerve Block SSNB Hydro dilatation HD and Their Combination in the Management of Periarthritis Shoulder Grade III 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Bhakti Singh 
Designation  Post Graduate Trainee 
Affiliation  NRS Medical College 
Address  Department of Physical Medicine & Rehabilitation NRS MEDICAL COLLEGE AND HOSPITAL 138 AJC Bose Road Kolkata 700014

Kolkata
WEST BENGAL
700014
India 
Phone  9647342662  
Fax    
Email  singhbhakti2.bs@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Saumen Kumar De 
Designation  Associate Professor 
Affiliation  NRS Medical College 
Address  Department of Physical Medicine & Rehabilitation NRS MEDICAL COLLEGE AND HOSPITAL 138 AJC Bose Road Kolkata 700014

Kolkata
WEST BENGAL
700014
India 
Phone  9433124596  
Fax    
Email  drsaumen16@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Saumen Kumar De 
Designation  Associate Professor 
Affiliation  NRS Medical College 
Address  Department of Physical Medicine & Rehabilitation NRS MEDICAL COLLEGE AND HOSPITAL 138 AJC Bose Road Kolkata 700014

Kolkata
WEST BENGAL
700014
India 
Phone  9433124596  
Fax    
Email  drsaumen16@yahoo.com  
 
Source of Monetary or Material Support  
NRS Medical College Kolkata 138 AJC Bose Road Kolkata 700014 
 
Primary Sponsor  
Name  NRS Medical College Kolkata 
Address  NRS Medical College Kolkata 138 AJC Bose Road Kolkata 700014 
Type of Sponsor  Government 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 Saumen Kumar De  NRS Medical College Kolkata  Department of Physical Medicine & Rehabilitation NRS Medical College 138 AJC Bose Road Kolkata 700014
Kolkata
WEST BENGAL 
9433124596

drsaumen16@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Nil Ratan Sircar Medical College  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Both Supra scapular nerve block (SSNB) and Hydrodillation  Both Supra scapular nerve block (SSNB) and Hydrodillation (SSNB) with 2ml of 2% lignocaine and 4ml of 0.2% Ropivacaine , 40mg triamcinolone acetonide Hydrodillation with 4 ml of lignocaine 2% , after 5 min 30-40 ml normal saline at glenohumerol joint slowly. follow up at 2,6 and 12 weeks. total duration 18 months 
Comparator Agent  Hydrodillation  Hydrodillation with 4 ml of lignocaine 2% , after 5 min 30-40 ml normal saline at glenohumerol joint slowly. follow up at 2,6 and 12 weeks. total duration 18 months  
Intervention  Supra scapular nerve block (SSNB)  2ml of 2% lignocaine and 4ml of 0.2% Ropivacaine , 40mg triamcinolone acetonide injection. follow up at 2,6 and 12 weeks. total duration 18 months 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Clinically diagnosis case of periarthritis shoulder Frozen shoulder stage III not managed by conservatively like Therapeutic exercise, Analgesic .
2. Adult below 60 years both gender
3.Patients with pain and stiffness at least 9 months duration.
4. Patients who will give consent to participate in the study.
 
 
ExclusionCriteria 
Details  1. Recent shoulder surgery/trauma within 4weeks , local infection
2. Uncontrolled Diabetes mellitus , hypothyroidism not adequately managed.
3. Pregnancy, Lactation
4. Pain cause due to disorder of Cervical spine, elbow, wrist or hand, CRPS
5. Neurological disease such as stroke, peripheral neuropathy that affected the shoulder
6. Patients has history of drug allergy to lignocaine, bupivacaine/ropivacaine,
7. Severe systemic disease like infection, malignancy, Coagulopathy,
8. Severe degenerative (Rheumatoid arthritis, osteoarthritis)
9. Patients has received nerve block or hydrodilatation preceding 4 week.
 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Visual Analogue Scale VAS  baseline
2 weeks
6 weeks
12 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Shoulder Pain and Disability Index SPADI Scale  baseline
2 weeks
6 weeks
12 weeks 
Pittsburgh Sleep Quality
Index PQSI
 

2 weeks
6 weeks
12 weeks 
 
Target Sample Size   Total Sample Size="165"
Sample Size from India="165" 
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 4 
Date of First Enrollment (India)   01/12/2025 
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="1"
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  
This randomized single blind three arm clinical trial aims to compare the effectiveness of Suprascapular Nerve Block, Hydrodilatation, and their combination in patients with Grade III periarthritis shoulder. A total of 165 adults below 60 years with at least nine months of shoulder pain and stiffness not responding to conservative treatment will be enrolled and randomized equally into three groups. All procedures will be performed under ultrasound guidance using standard drug protocols.
The primary objective is to assess pain reduction using the Visual Analogue Scale. Secondary objectives include improvement in range of motion measured by goniometry, functional outcome assessed by the Shoulder Pain and Disability Index, and sleep quality assessed using the Pittsburgh Sleep Quality Index.
Follow up assessments will be conducted at two weeks, six weeks, and twelve weeks. Patients with recent trauma or surgery, uncontrolled endocrine disorders, infection, neurological illness affecting the shoulder, coagulopathy, or drug allergies will be excluded.
Data will be analyzed using appropriate parametric or non parametric tests. The study is expected to identify whether the combination of suprascapular nerve block and hydrodilatation provides superior clinical improvement compared to either treatment alone in frozen stage periarthritis shoulder.

 
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