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CTRI Number  CTRI/2025/10/096366 [Registered on: 22/10/2025] Trial Registered Prospectively
Last Modified On: 21/10/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Biological
Other (Specify) [Platelet rich plasma, steroid]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of pain relief in patients with low back ache, who have undergone biacuplasty with intradiscal steroid vs biacuplasty with intradiscal platelet rich plasma  
Scientific Title of Study   Comparison of intradiscal platelet rich plasma vs steroid in patients undergoing biacuplasty for discogenic low back pain. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Anuj Jain 
Designation  Additional Professor 
Affiliation  All India Institute Of Medical Sciences, Bhopal 
Address  Department Of Anesthesiology , AIIMS Bhopal, Saket Nagar

Bhopal
MADHYA PRADESH
462020
India 
Phone  9755702644  
Fax    
Email  anuj.anesth@aiimsbhopal.edu.in  
 
Details of Contact Person
Scientific Query  
Name  Anuj Jain 
Designation  Additional Professor 
Affiliation  All India Institute Of Medical Sciences, Bhopal 
Address  Department Of Anesthesiology , AIIMS Bhopal, Saket Nagar

Bhopal
MADHYA PRADESH
462020
India 
Phone  9755702644  
Fax    
Email  anuj.anesth@aiimsbhopal.edu.in  
 
Details of Contact Person
Public Query  
Name  Anuj Jain 
Designation  Additional Professor 
Affiliation  All India Institute Of Medical Sciences, Bhopal 
Address  Department Of Anesthesiology , AIIMS Bhopal, Saket Nagar

Bhopal
MADHYA PRADESH
462020
India 
Phone  9755702644  
Fax    
Email  anuj.anesth@aiimsbhopal.edu.in  
 
Source of Monetary or Material Support  
All India Institute Of Medical Sciences, Saket Nagar, Bhopal, Madhya Pradesh - 462020, India 
 
Primary Sponsor  
Name  NIL 
Address  NA 
Type of Sponsor  Other [NA] 
 
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 Anuj Jain  All India Institute Of Medical Sciences, Bhopal  Modular OT, 2nd floor, AIIMS- Bhopal, Saket Nagar.
Bhopal
MADHYA PRADESH 		 9755702644

anuj.anesth@aiimsbhopal.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
AIIMS Bhopal Institutional Human Ethics Committee- Student Research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M513||Other thoracic, thoracolumbar andlumbosacral intervertebral disc degeneration,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Intradiscal platelet rich plasma injection  After the patients undergo biacuplasty, they will be immediately injected with 2ml of PRP-LP (Leucocyte poor PRP) prepared in Precurecell LP kits , Rescues lifesciences, Bangalore India. Total duration of the procedure would be approximately 1 hour  
Comparator Agent  Intradiscal steroid injection  Patients under the steroid group will be injected with 40 mg of Triamcinolone, immediately after biacuplasty is done. Total duration of the procedure would be approximately 1 hour 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Adults aged between 18–65 years
Patients with chronic low back pain for more than 3 months
MRI evidence showing disc degeneration or annular tear
Patients with failed conservative therapy of at least 3 months.
 
 
ExclusionCriteria 
Details  Patients with radiculopathy or spinal canal stenosis
Patients who have undergone prior lumbar surgery
Patients with spinal infection, tumors, fractures, or instability
Currently on anti-coagulants or patients with coagulopathy
Pregnant or lactating women
Patients with known allergy to drugs and materials used .
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the analgesic efficacy of biaculoplasty + intradiscal leucocyte poor PRP and biaculoplasty + intradiscal steroid in patients with chronic discogenic low back pain at 3,6 and 12 months after the procedure using NRS (Numerical rating scale)
 		 To compare the analgesic efficacy of biaculoplasty + intradiscal leucocyte poor PRP and biaculoplasty + intradiscal steroid in patients with chronic discogenic low back pain at 3,6 and 12 months after the procedure using NRS (Numerical rating scale)
 
 
Secondary Outcome  
Outcome  TimePoints 
Compare functional improvement using the Oswestry Disability Index (ODI) in
patients with chronic discogenic low back pain after biaculoplasty + intradiscal leucocyte poor PRP and biaculoplasty + intradiscal steroid at 3,6 and 12 months after the procedure.
Evaluate quality of life changes using SF12 at 3,6 and 12months
Assess patient satisfaction using Patient Global Impression of Change (PGIC)
scale
To identify predictors of treatment success in each group.
Monitor adverse events.
 		 3, 6, 12 months 
 
Target Sample Size   Total Sample Size="28"
Sample Size from India="28" 
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)   01/11/2025 
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="2"
Months="0"
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   Biaculoplasty has shown to be significantly beneficial in improving patient outcomes. This study aims to combine biaculoplasty with leucocyte poor PRP and steroid intradiscal injections. We hypothesize that combining and comparing both has better results when compared with biaculoplasty alone.  
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