| CTRI Number |
CTRI/2023/09/057870 [Registered on: 20/09/2023] Trial Registered Prospectively |
| Last Modified On: |
19/09/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to compare which treatment is better for the management of degenerative low back pain -ultrasound guided caudal epidural injection of platelet rich plasma or corticosteroid |
|
Scientific Title of Study
|
Comparing the clinical efficacy of ultrasound guided Caudal epidural injection of Platelet rich plasma with Corticosteroid in Chronic degenerative lumbar spinal pain - 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 |
ANJUSHA E V |
| Designation |
PG STUDENT |
| Affiliation |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES,PATNA |
| Address |
DEPARTMENT OF PMR
ALL INDIA INSTITUTE OF MEDICAL SCIENCES PATNA
PHULWARISHERIF
PATNA
Patna
BIHAR
801507
India |
| Phone |
8848452676 |
| Fax |
|
| Email |
anjusha692@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr SANJAY KUMAR PANDEY |
| Designation |
PROFESSOR AND HEAD OF DEPARTMENT ,PMR DEPARTMENT |
| Affiliation |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES,PATNA |
| Address |
DEPARTMENT OF PMR
ALL INDIA INSTITUTE OF MEDICAL SCIENCES PATNA
PHULWARISHERIF
PATNA
Patna
BIHAR
801507
India |
| Phone |
8102922824 |
| Fax |
|
| Email |
drsanjaykr1@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
ANJUSHA E V |
| Designation |
PG STUDENT |
| Affiliation |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES,PATNA |
| Address |
DEPARTMENT OF PMR
ALL INDIA INSTITUTE OF MEDICAL SCIENCES
PATNA
PHULWARISHERIF
PATNA
Patna
BIHAR
801507
India |
| Phone |
8848452676 |
| Fax |
|
| Email |
anjusha692@gmail.com |
|
|
Source of Monetary or Material Support
|
| AIIMS Patna, Phulwari sharif ,Patna ,Bihar -801507 |
|
|
Primary Sponsor
|
| Name |
AIIMS Patna |
| Address |
AIIMS Patna ,
Phulwari sharif
Patna
Bihar -801507 |
| 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 |
| DrAnjusha E V |
AIIMS Patna |
Department of PMR
PMR building
Patna
BIHAR |
8848452676
anjusha692@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC-AIIMS PATNA |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M00-M99||Diseases of the musculoskeletal system and connective tissue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Caudal epidural injection of Corticosteroid (triamcinolone acetonide) |
Ultrasound guided caudal epidural injection of corticosteroid (Triamcinolone acetonide- 40mg/ml) 60mg will be given (only once )at the beginning of the study |
| Intervention |
Ultrasound guided Caudal epidural injection of autologous Platelet rich plasma |
Ultrasound guided Caudal epidural injection of 15ml autologous platelet rich plasma will be given only once at the beginning of the study (only once) |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients with degenerative lumbar spinal pain attending AIIMS PATNA OPD and consenting patients |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assessment of pain using Visual analogue scale and Numerical pain rating scale |
Follow up will be done at baseline ,15 days ,1 month and 3 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Assessment of disability and functional status of the patient using Modified oswestry low back pain disability questionnaire |
Follow up will be done at baseline ,15 days ,1 month and 3 month |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
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)
|
30/09/2023 |
| 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="0"
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
|
It is a randomised control study comparing the clinical efficacy of ultrasound guided caudal epidural injection of platelet rich plasma with corticosteroid in chronic degenerative lumbar spinal pain .Patients would be included from those attending AIIMS PATNA OPD.Patients will be randomized into 2 group -Intervention group(Platelet rich plasma ) and comparator group(Triamcinolone acetonide group).Injection will be given only once at the beginning of the study .Then the patients will be followed up with NPRS,VAS and Modified Oswestry low back pain disability questionnaire at baseline ,after 15 days ,1 month and 3 month. |