| CTRI Number |
CTRI/2023/10/058975 [Registered on: 20/10/2023] Trial Registered Prospectively |
| Last Modified On: |
08/10/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Biological
Other (Specify) [Regenerative therapy] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of two medications given under ultrasound guidance in pain and functional functional improvement of patients with jaw pain due to osteoarthritis |
|
Scientific Title of Study
|
Comparison of ultrasound guided intra-articular injection of platelet rich plasma and triamcinolone acetonide in the reduction of pain and functional improvement in primary temporomandibular joint osteoarthritis: 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 |
Shruti Pandey |
| Designation |
Post graduate student |
| Affiliation |
Regional Institute of Medical Sciences |
| Address |
Department of Physical Medicine and Rehabilitation
Regional Institute of Medical Sciences, Lamphelpat, Imphal
Dept physical medicine and rehabilitation besides punjab national bank,Regional Institute of Medical Sciences Lamphelpat, Imphal
Imphal West
MANIPUR
795004
India |
| Phone |
08981795747 |
| Fax |
|
| Email |
pandeyshruti20@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.Longjam Nilachandra Singh |
| Designation |
Professor and Head of Dept. of PMR |
| Affiliation |
Regional Institute of Medical Sciences |
| Address |
Department of Physical Medicine and Rehabilitation
Regional Institute of Medical Sciences, Lamphelpat, Imphal
Dept.of physical medicine and rehabilitation, Regional institute of medical sciences, Lamphelpat, Imphal
Imphal West
MANIPUR
795004
India |
| Phone |
08981795747 |
| Fax |
|
| Email |
drnilalong@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shruti Pandey |
| Designation |
Post graduate student |
| Affiliation |
Regional Institute of Medical Sciences |
| Address |
Department of Physical Medicine and Rehabilitation
Regional Institute of Medical Sciences, Lamphelpat, Imphal
Dept.of physical medicine and rehabilitation, Regional institute of medical sciences, Lamphelpat, Imphal
Imphal West
MANIPUR
795004
India |
| Phone |
08981795747 |
| Fax |
|
| Email |
pandeyshruti20@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Shruti Pandey |
| Address |
Department of Physical Medicine and Rehabilitation, Regional Institute of Medical Sciences, Lamphelpat, Imphal, Manipur |
| 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 |
| DrShruti Pandey |
Regional Institute Of Medical Sciences |
Departmentof Physical Medicine and Rehabilitation, Lamphelpat,Imphal
Imphal West
MANIPUR |
8981795747
pandeyshruti20@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Research Ethics Board RIMS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M19||Other and unspecified osteoarthritis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
I/A injection of platelet rich plasma(1ml) in temporomandibular joint given once |
I/A injection of platelet rich plasma(1ml) under ultrasound guidance given once on day 0(first visit after baseline assessment) |
| Comparator Agent |
I/A injection of triamcinolone acetonide 1ml(20mg) given once |
I/A injection of triamcinolone acetonide 1ml(20mg) in temporomendobular joint under ultrasound guidance given once on day 0(after baseline assessment) |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
symptomatic primary temporomandibular joint osteoarthritis (TMJ OA)
unilateral TMJ OA
CT confirmed cases of TMJ OA
patients willing to be part of study and follow up |
|
| ExclusionCriteria |
| Details |
patients with previous trauma or dental intervention
H/O inflammatory arthritis
uncontrolled systemic illness
bleeding disorder
allergic to local anaesthetics
thrombocytopenia
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. pain through VAS
|
1. 1 week
2. 4 week
3. 12 week
4. 24 week
Pain expected to improve at 1 week with prolong effect till 24 week of follow up |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Pain and function of temporomandibular joint assessed through VAS and MFIQ |
1. 1 week
2. 4 week
3. 12 week
4. 24 week
VAS improvement expected from 1 week MFIQ score improvement expected on later follow up till 24 weeks, at 24 weeks MFIQ score improvement is questionable |
|
|
Target Sample Size
|
Total Sample Size="38"
Sample Size from India="38"
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 2 |
|
Date of First Enrollment (India)
|
20/10/2023 |
| 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="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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [pandeyshruti20@gmail.com].
- For how long will this data be available start date provided 01-03-2025 and end date provided 01-04-2028?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
temporomandibular joint osteoarthritis (TMJ OA) affects 5-12% of world population and is more prevalent in india with 22-29% occurrence and without intervention it negatively affects quality of life. primary TMJ OA is characterized by absence of distinct local or systemic factors. there are many trreatment options like occlusal splint, NSAIDs, I/A steroid injection, hyalouronic injection, but with recent advancement and studies coming up with platelet rich plasma (PRP) showing it’s anti- inflammatory and regenerative properties makes it novel treatment option for management of pain and function among patients suffering with TMJ OA . This study will be conducted to compare the efficacy of I/A injection under ultrasound guidance of steroid (triamcinolone acetonide) with PRP in reduction of pain and functional improvement in primary cases of TMJ OA . Study will be a randomized controlled trial conducted in Regional Institute of Medical Science, Imphal. outcome measures will be measured at baseline at 1, 4, 12 and 24 weeks respectively. Data will be analyzed using IBM-SPSS 25 version, for descritive data chi square will be used and for comparative data student t test, paired t test and ANOVA will be used and p value of <0.05 will be taken as significant |