| CTRI Number |
CTRI/2025/10/095823 [Registered on: 09/10/2025] Trial Registered Prospectively |
| Last Modified On: |
01/04/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Suprascapular Nerve Block: A Promising Addition to Corticosteroid Injection for Adhesive Capsulitis Management |
|
Scientific Title of Study
|
ROLE OF SUPRASCAPULAR NERVE BLOCK IN ADDITION TO INTRA-ARTICULAR
CORTICOSTEROID INJECTION ON PAIN AND RANGE OF MOTION IN PATIENTS
WITH ADHESIVE CAPSULITIS OF SHOULDER JOINT |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
ATRIJIT KUMAR SAHA |
| Designation |
Post Graduate Trainee |
| Affiliation |
R. G. Kar Medical College and Hospital, Kolkata |
| Address |
Department of Anaesthesia, Pain Medicine and critical care medicine, Emergency building, 7th floor, 1, KHUDIRAM BOSE SARANI, SHYAM BAZAR, KOLKATA 700004
Department of Anaesthesia, Pain Medicine and critical care medicine, Emergency buildingEmergency building, 7th floor, 1, KHUDIRAM BOSE SARANI, SHYAM BAZAR, KOLKATA 700004
Kolkata
WEST BENGAL
700004
India |
| Phone |
7003759803 |
| Fax |
|
| Email |
dratrijitsaha@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Susmita Bhattacharyya |
| Designation |
Professor |
| Affiliation |
R. G. Kar Medical College and Hospital, Kolkata |
| Address |
Emergency building, 7th floor, 1, KHUDIRAM BOSE SARANI, SHYAM BAZAR, KOLKATA 700004
Emergency building, 7th floor, 1, KHUDIRAM BOSE SARANI, SHYAM BAZAR, KOLKATA 700004
Hugli
WEST BENGAL
700004
India |
| Phone |
9830438434 |
| Fax |
|
| Email |
aratisahax@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
ATRIJIT KUMAR SAHA |
| Designation |
Post Graduate Trainee |
| Affiliation |
R. G. Kar Medical College and Hospital, Kolkata |
| Address |
Department of Anaesthesia, Pain Medicine and critical care medicine, Emergency building, 7th floor, 1, KHUDIRAM BOSE SARANI, SHYAM BAZAR, KOLKATA 700004
Department of Anaesthesia, Pain Medicine and critical care medicine, Emergency building, 7th floor, 1, KHUDIRAM BOSE SARANI, SHYAM BAZAR, KOLKATA 700004
Hugli
WEST BENGAL
712223
India |
| Phone |
7003759803 |
| Fax |
|
| Email |
dratrijitsaha@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
R. G. Kar Medical College and Hospital |
| Address |
1, Khudiram Bose Sarani, Shyam Bazar, Kolkata , 700004 |
| 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 |
| ATRIJIT KUMAR SAHA |
PAIN CLINIC AND INTERVENTION THEATRE, R. G. KAR MEDICAL COLLEGE AND HOSPITAL |
Pain Clinic, OPD Building, Room no. 105, 1, KHUDIRAM BOSE SARANI, SHYAM BAZAR, KOLKATA 700004
Hugli
WEST BENGAL |
07003759803
dratrijitsaha@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institution Ethics Committee, R. G. Kar Medical College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 3||Administration, (2) ICD-10 Condition: M750||Adhesive capsulitis of shoulder, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Intra-articular injection at glenohumeral joint (GHJ) |
Ultrasonography guided Intra-articular injection to GHJ with Methylprednisolone (MP) 60mg+ 1.5ml Normal Saline (Total drug volume 3ml). |
| Intervention |
Supra Scapular Nerve Block |
Ultrasonography and Peripheral Nerve Stimulator guided Suprascapular Nerve Block (SSNB) with Lignocaine(2%) 2.5ml+ Methylprednisolone (60mg)(total drug volume 4ml). |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
-Patients with history of adhesive capsulitis of shoulder joint
-AMERICAN SOCIETY OF ANAESTHESIOLOGIST GRADING status I or II
-Patients above 45 years and below 75 years of age
-Patients who gave written informed consent to be the part of the study |
|
| ExclusionCriteria |
| Details |
-Patients who refused to give consent
-ASA grade III or above
-Severe pain at rest, history of trauma, systemic inflammatory disease, history of rotator cuff tear, radiological evidence of osteoarthritis of glenohumeral joint or any fracture
-Patients with allergy to local anesthetic agents and Corticosteroids
-Pregnancy, neoplasm, surgery to the shoulder in last 12 months
-Likely not to comply with follow up
-Uncontrolled systemic disorder, Bleeding disorder, Alcoholism |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| It is expected that when SSNB will be given along with intra-articular corticosteroid injection to GHJ in patients suffering from adhesive capsulitis of shoulder joint, it will more effectively reduce pain, improve the range of motion of shoulder. |
It is expected that when SSNB will be given along with intra-articular corticosteroid injection to GHJ in patients suffering from adhesive capsulitis of shoulder joint, it will more effectively reduce pain, improve the range of motion of shoulder. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The patients who will be undergone SSNB+ IA Corticosteroid injection to GHJ are expected to have reduction in analgesics intake and increased Range Of Motion of shoulder joint |
|
|
|
Target Sample Size
|
Total Sample Size="56"
Sample Size from India="56"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="56" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
20/10/2025 |
| Date of Study Completion (India) |
12/01/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="11"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
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)
|
Shoulder pain due to adhesive capsulitis is a common cause of reduced shoulder function. The treatment of this condition remains unsatisfactory. Oral analgesics provide temporary pain relieve but the relief is not sustained. Suprascapular Nerve Block (SSNB) along with intra-articular (IA) corticosteroid injection to Glenohumeral Joint (GHJ) may show improved results in reduction of pain and improve shoulder function, so that patients can continue physical rehabilitation/ exercise, that will reduce the course of the disease. Thus, efficacy of SSNB along with IA corticosteroid injection to GHJ will be observed from study. |