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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 
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