| CTRI Number |
CTRI/2025/03/083608 [Registered on: 27/03/2025] Trial Registered Prospectively |
| Last Modified On: |
24/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Efficacy of platelet rich plasma versus steroid infiltration of low back pain |
|
Scientific Title of Study
|
Efficacy of Platelet-rich plasma vs Steroid Infiltration in management of Low Back Pain: A prospective randomized control 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 Rohit Randad |
| Designation |
Junior Resident |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Department of Orthopaedics, Ground Floor, AVBRH Building Sawangi Meghe
Wardha MAHARASHTRA 442107 India |
| Phone |
8003804444 |
| Fax |
|
| Email |
randadrohit@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Sanjay Deshpande |
| Designation |
Professor |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Department of Orthopaedics, Ground Floor, AVBRH Building Sawangi Meghe
Wardha MAHARASHTRA 441207 India |
| Phone |
9860452519 |
| Fax |
|
| Email |
svd1111@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Rohit Randad |
| Designation |
Junior Resident |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Department of Orthopaedics, Ground Floor, AVBRH Building Sawangi Meghe
Wardha MAHARASHTRA 442107 India |
| Phone |
8003804444 |
| Fax |
|
| Email |
randadrohit@gmail.com |
|
|
Source of Monetary or Material Support
|
| Datta Meghe Institute of Higher Education and Research ,Sawangi Meghe Wardha, India 442001 |
|
|
Primary Sponsor
|
| Name |
Datta Meghe Institute of Higher Education and Research |
| Address |
Sawangi Meghe Wardha, India 442001 |
| Type of Sponsor |
Private 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 |
| Dr Rohit Randad |
Acharya Vinoba Bhave Rural Hospital |
Department of Orthopaedics, Ground Floor, AVBRH Building Sawangi Meghe
Wardha MAHARASHTRA |
8003804444
randadrohit@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Datta Meghe Institute of Higher Education and Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: M45-M49||Spondylopathies, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Platelet rich plasma |
1 dose of Platelet rich plasma would be injected at the facet joint, of patient having low back ache at the time of surgery. Follow up will be done at 1 week, 1 month, 2 month, 3 month,6 month. |
| Comparator Agent |
Steroid infiltration |
Methyl Prednisolone injection 80 mg/ 2ML, intra articular will be given on day 1. Follow up will be done at 1 week, 1 month, 2 month, 3 month,6 month. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
All Skeletally matured patients with either sex.
Continuous or intermittent LBP for at least 3 months.
|
|
| ExclusionCriteria |
| Details |
Skeletally immature patients.
Patient with infection, traumatic spine injuries, spinal tumours, spinal deformities, and congenital spinal anomalies.
Pregnant women or women who are breast feeding.
Operated cases of spinal fusion surgery.
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in pain at facet joint after platelet rich plasma injection as compared to steroid injection . |
Assessment will be done at 1 week ,1 month ,2 month ,3 month ,6 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduction in Oswestry Low back disability score after platelet rich plasma injection as compare to steroid injection |
Assessment will be done at 1 week , 1 month ,2 month ,3 month ,6 month |
|
|
Target Sample Size
|
Total Sample Size="55" Sample Size from India="55"
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)
|
28/04/2025 |
| 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="15" |
|
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
|
One of the most prevalent conditions and a major contributor to morbidity and socioeconomic loss in society is low back pain (LBP). It is the second most common cause of disability among adults and a major factor in the physical inactivity of those under 45 years of age. Therefore, it is one of the among the costliest musculoskeletal conditions and has a significant illness burden on society. Non-specific low back pain can be characterized as acute if lasting less than six weeks, sub-acute if lasting between six weeks and three months, and chronic if lasting for longer than three months. Pain is often initiated by instability at a single motion segment, or the result of abnormal motion of vertebral bodies. When assessing patients with LBP, it is important to look for radicular symptoms such as radiating leg pain, sensory deficits, and neurologic lower limb deficits such as reduced reflexes and motor weakness. There are several elements involved in this diseased process. These include facet arthropathy, ligamentum flavum hypertrophy, ossification of the posterior longitudinal ligament, congenitally small neural foramen, ligament laxity, and subluxation, as well as disc degeneration resulting in herniation. Growing older is a factor in these degenerative processes, therefore it seems sense to believe that as life expectancies rise internationally, so too will the prevalence of low back pain. Without the need for invasive or surgical treatments, patients with LBP may typically be treated conservatively with a mix of pharmacological and nonpharmacological therapy. Bed rest, analgesics such acetaminophen and nonsteroidal anti-inflammatory medicines (NSAIDs), muscle relaxants, oral or parenteral steroids, opioids, and therapeutic exercises are all included in conservative therapy. Injections of lumbar or caudal epidural glucocorticoids can be used to alleviate pain if these don’t work. When pain is not relieved by conservative measures or when neurological impairments appear, surgery becomes necessary. Therefore, this study will be conducted to examine the effectiveness of PRP infiltration versus steroid infiltration (Methyl prednisolone acetate 80 mg/ 2ML) in treatment of facet joint pains. |