| CTRI Number |
CTRI/2024/11/076322 [Registered on: 06/11/2024] Trial Registered Prospectively |
| Last Modified On: |
05/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Biological |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To Evaluate the Effect Of 3 Treatment Methods (Supra scapular Nerve Block, Platelet Rich Plasma, conservative exercise program ) On Pain And Range Of Motion In Patients Of Frozen Shoulder |
|
Scientific Title of Study
|
Comparison Of Efficacy Of Supra scapular Nerve Block, Platelet Rich Plasma And Exercise Program For Treatment Of Treatment Of Adhesive Capsulitis Of Shoulder joint -A Randomized Controlled Study |
| 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 Harshit Tripathi |
| Designation |
Junior Resident |
| Affiliation |
King Georges Medical University, Lucknow, UP |
| Address |
Department of Physical Medicine and Rehabilitation, RALC building, KGMU Lucknow.
Department of Physical Medicine and Rehabilitation, RALC building, KGMU Lucknow.
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
7522848947 |
| Fax |
|
| Email |
harshitforyou@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ganesh Yadav |
| Designation |
Associate Professor |
| Affiliation |
King Georges Medical University, Lucknow, UP. |
| Address |
Department of Physical Medicine and Rehabilitation, RALC Building, KGMU Lucknow.
Department of Physical Medicine and Rehabilitation, RALC Building, KGMU Lucknow.
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
9457191240 |
| Fax |
|
| Email |
ganeshyadav.pmr@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ganesh Yadav |
| Designation |
Associate Professor |
| Affiliation |
King Georges Medical University, Lucknow, UP. |
| Address |
Department of Physical Medicine and Rehabilitation, RALC Building, KGMU Lucknow.
Department of Physical Medicine and Rehabilitation, RALC Building, KGMU Lucknow.
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
9457191240 |
| Fax |
|
| Email |
ganeshyadav.pmr@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Harshit Tripathi |
| Address |
Junior Resident, Department of Physical Medicine and Rehabilitation, RALC Building, King Georges Medical University, Lucknow-226003, Uttar Pradesh, India |
| Type of Sponsor |
Other [Self] |
|
|
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 Harshit Tripathi |
King Georges Medical University, Lucknow UP |
OPD Room no 06,Department Of Physical Medicine And Rehabilitation, RALC Building
Lucknow
UTTAR PRADESH |
7522848947
harshitforyou@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, King Georges Medical University Lucknow |
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 |
| Intervention |
Platelet Rich Plasma |
USG Guided 4ML Platelet Rich Plasma(PRP) in Gleno humeral Joint.
PRP will be given once to each subject and follow up will be at 2 weeks and 6 weeks.
Total duration of study is 18months
|
| Comparator Agent |
USG Guided Supra Scapular Nerve Block |
SUPRA SCAPULAR NERVE BLOCK WITH INJ TRIAMCINOLONE AND BUPIVACAINE.
Nerve block will be done once on each subject and follow up will be at 2 weeks and 6 weeks.
Total duration of study is 18 months |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Painful & Stiff Shoulder joint
Shoulder Pain that interferes with Activities of Daily Living(ADL) |
|
| ExclusionCriteria |
| Details |
History Of Significant Trauma To Shoulder
Rotator Cuff Tear |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Shoulder Pain And Disability Index(SPADI)
Numerical Pain Rating Scale (NPRS)
GONIOMETRY |
Immediate Post Procedure
2 Weeks
6Weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
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
|
N/A |
|
Date of First Enrollment (India)
|
18/11/2024 |
| 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
|
Adhesive capsulitis of shoulder is defined as disorder characterized by
progressive pain and loss of mobility of glenohumeral joint. Main focus of treatment is pain control and
restoring range of motion. There are few studies to compare platelet rich
plasma with supra scapular nerve block for treatment of adhesive capsulitis. The aim of the
study is to assess the efficacy of USG guided suprascapular nerve block and platelet rich plasma in providing pain
relief and improving range of motion of shoulder joint in adhesive capsulitis. After
selection of study population based on inclusion criteria , and pre intervention base line
assessment is done using SPADI,NPRS and goniometry. randomization is done on basis of computer generated
table. Patients are divided into 3 groups and assessment is done at immediate
post procedure ,2 weeks and 6 weeks
|