| CTRI Number |
CTRI/2023/06/054516 [Registered on: 28/06/2023] Trial Registered Prospectively |
| Last Modified On: |
27/06/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Biological |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
comparison of effectiveness of two interventions in improvement of pain and function in adhesive capsulitis |
|
Scientific Title of Study
|
Effectiveness of ultrasound guided intraarticular injection of platelet rich plasma compared with triamcinolone hexacetonide in improvement of pain and function in patients with adhesive capsulitis: A randomized controlled 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 |
Yendrembam Anamika Chanu |
| Designation |
Post graduate student |
| Affiliation |
Regional Institute of Medical Sciences |
| Address |
Department of Physical Medicine and Rehabilitation,
Regional Institute of Medical Sciences, Lamphelpat, Imphal
Imphal West
MANIPUR
795004
India |
| Phone |
9383280981 |
| Fax |
|
| Email |
yendrembamanamika@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Naorem Bimol |
| Designation |
Associate Professor |
| Affiliation |
Regional Institute of Medical Sciences |
| Address |
Department of Physical Medicine and Rehabilitation,
Regional Institute of Medical Sciences, Lamphelpat, Imphal
Imphal West
MANIPUR
795004
India |
| Phone |
7005291542 |
| Fax |
|
| Email |
bimoldr@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Naorem Bimol |
| Designation |
Associate Professor |
| Affiliation |
Regional Institute of Medical Sciences |
| Address |
Department of Physical Medicine and Rehabilitation,
Regional Institute of Medical Sciences, Lamphelpat, Imphal
Imphal West
MANIPUR
795004
India |
| Phone |
7005291542 |
| Fax |
|
| Email |
bimoldr@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Regional Institute of Medical Sciences,Lamphelpat, Imphal- 795004, Manipur, India |
|
|
Primary Sponsor
|
| Name |
Yendrembam Anamika Chanu |
| Address |
Post graduate trainee, Department of Physical Medicine and Rehabilitation, Regional Institute of Medical Sciences,Lamphelpat, Imphal- 795004, Manipur, 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 |
| Yendrembam Anamika Chanu |
Regional Institute of Medical Sciences |
Department of Physical
Medicine and
Rehabilitation Regional
Institute of Medical
Sciences Lamphelpat,
Imphal- 795004
Imphal West
MANIPUR |
9383280981
yendrembamanamika@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Research Ethics Board, Regional Institute of Medical Sciences |
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 |
Intra-articular injection of Platelet rich plasma into the shoulder |
Single injection of 4ml Platelet rich plasma into the shoulder joint under ultrasound guidance |
| Comparator Agent |
Intra-articular injection of Triamcinolone hexacetonide into the shoulder joint |
Single Injection of 1ml Triamcinolone hexacetonide 20mg/ml into the shoulder joint under ultrasound guidance |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosed case of adhesive capsulitis,
Patients who are willing to comply with the study and follow up assessments
|
|
| ExclusionCriteria |
| Details |
Patients with uncontrolled diabetes
History of shoulder trauma/surgery
History of injection in the shoulder joint in past three months
Non-steroidal anti-inflammatory drugs intake in last seven days
Coagulopathy
Thrombocytopenia (1.5 lakh/microlitre)
Autoimmune disorders
Impaired cognition
Any febrile or infectious disease (systemic & local)
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Shoulder Pain and Function in terms of Shoulder Pain and Disability Index (SPADI) |
1 week, 4 week, 12 week, 24 week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Pain in terms of Visual Analogue Scale (VAS) |
1 week, 4 weeks, 12 weeks, 24 weeks |
| Shoulder function in terms of Range of Motion |
1 week, 4 weeks, 12 weeks, 24 weeks |
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
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)
|
05/07/2023 |
| 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="4"
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 study is a randomized, parallel group, active control trial comparing the effectiveness of ultrasound guided intra articular injection of 4ml Platelet rich plasma with 1 ml triamcinolone hexacetonide 20mg/ml in improvement of pain and function in 64 patients with adhesive capsulitis of shoulder. This study will be conducted in Department of Physical Medicine and Rehabilitation , Regional Institute of Medical Sciences, Imphal, Manipur in India. The primary outcome measures will be improvement in pain and function as measured by SPADI and secondary outcome measures will be pain measured by VAS and shoulder function measured by Range of motion which all will be asses at 1week, 4weeks, 12 weeks and 24 weeks post intervention. |