| 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
|
|
|
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
|
|
|
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.
|