| CTRI Number |
CTRI/2025/02/081218 [Registered on: 24/02/2025] Trial Registered Prospectively |
| Last Modified On: |
19/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia
Other (Specify) [minimally invasive] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of 2 treatment options in frozen shoulder. |
|
Scientific Title of Study
|
Comparative study of functional outcome of suprascapular nerve block vs hydrodilatation in treatment of adhesive capsulitis - a prospective interventional double arm randomized 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 |
Ashwarya Menon |
| Designation |
postgraduate student |
| Affiliation |
Esic Medical College and hospital |
| Address |
Department of Physical Medicine and Rehabilitation, ESIC medical college and hospital ,
sanathnagar, HYDERABAD , TELANGANA , 500018 , INDIA .
Hyderabad
TELANGANA
500018
India
Hyderabad
TELANGANA
500018
India |
| Phone |
9962479584 |
| Fax |
|
| Email |
ashwarya.menon23@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr G Sambi Reddy |
| Designation |
HOD , Department of Physical Medicine and Rehabilitation |
| Affiliation |
ESIC MEDICAL COLLEGE AND HOSPITAL |
| Address |
Department of Physical Medicine and Rehabilitation, ESIC medical college and hospital ,
sanathnagar , HYDERABAD , TELANGANA , 500018 , INDIA .
Hyderabad
TELANGANA
500018
India
Hyderabad
TELANGANA
500018
India |
| Phone |
9848260927 |
| Fax |
|
| Email |
sambireddy57@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr G Sambi Reddy |
| Designation |
HOD , Department of Physical Medicine and Rehabilitation |
| Affiliation |
ESIC MEDICAL COLLEGE AND HOSPITAL |
| Address |
Department of Physical Medicine and Rehabilitation, ESIC medical college and hospital ,
sanathnagar , HYDERABAD , TELANGANA , 500018 , INDIA .
Hyderabad
TELANGANA
500018
India
Hyderabad
TELANGANA
500018
India |
| Phone |
9848260927 |
| Fax |
|
| Email |
sambireddy57@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Department of physical medicine and rehabilitation , ESIC medical college and hospital , sanathnagar , Hyderabad -
500018 , Telangana , India |
|
|
Primary Sponsor
|
| Name |
Ashwarya Menon |
| Address |
Post graduate student , Department of physical medicine and rehabilitation, ESIC medical
college and hospital , Sanathnagar , Hyderabad , Telangana ,
500018 , India . |
| Type of Sponsor |
Other [principal investigator] |
|
|
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 Ashwarya Menon |
Esic medical college and hospital |
Room no 1 ,
Department of physical medicine adn rehabilitation , ESIC medical college and hospital , Sanath nagar, Hyderabad , Telangana
500018 , India .
Hyderabad
TELANGANA |
9962479584
ashwarya.menon23@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethics committee , ESIC Medical College and Hospital and ESIC Super Specialty Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M750||Adhesive capsulitis of shoulder, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Hydro dilatation |
Patients were administered 4 ml of triamcinolone acetonide with 4 ml of lidocaine and 12 ml of normal saline into the posterior glenohumeral recess under ultrasound guidance and functional improvement assessed. |
| Intervention |
suprascapular nerve block |
Block of Suprascapular nerve , under ultrasound guidance, using a solution of methylprednisolone 40mg and 4 ml of lidocaine via posterior approach with a 21 G needle and functional improvement assessed. |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
patients willing for followup. patients with clinical diadnosis of adhesive capsulitis . |
|
| ExclusionCriteria |
| Details |
prior history of in injury/fracture around shoulder , patients who didnt provide consent , any active sepsis , coagulation disorder |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| improvements in symptoms such as shoulder pain , and range of motion. |
patients are followed up at day 0 , 6 weeks and 3 months in terms of Range of motion Vas score for pain. |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="35"
Sample Size from India="35"
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)
|
05/03/2025 |
| 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 Applicable |
| 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 is a prospective randomized interventional study to compare the efficacy of suprascapular nerve block vs hydrodilation to improve the functional outcome in patients with adhesive capsulitis and compare the efficacy of both in reducing pain , increasing range of motion , and improving shoulder function and find which offers more effective improvements in patient symptoms. |