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CTRI Number  CTRI/2025/07/090225 [Registered on: 04/07/2025] Trial Registered Prospectively
Last Modified On: 03/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   PRP and Physiotherapy for Nerve and Disc Recovery in Lower Back Disc Herniation 
Scientific Title of Study   Effectiveness of Ultrasound-Guided Platelet-Rich Plasma Combined with Physiotherapy on Disc Morphology and Neurophysiology in L5/S1 Lumbar Disc Herniation 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Rayhan Islam 
Designation  Postgraduate student 
Affiliation  Jashore University of Science and Technology 
Address  Room - 304, Department of Physiotherapy and Rehabilitation, Jashore University of Science and Technology, Jashore-7408, Bangladesh



7408
Other 
Phone  8801680310515  
Fax    
Email  rayhanislam.just@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Kazi Md Amran Hossain 
Designation  Lecturer  
Affiliation  Jashore University of Science and Technology 
Address  Room - 302, Department of Physiotherapy and Rehabilitation, Jashore University of Science and Technology, Jashore-7408, Bangladesh



7408
Other 
Phone  8801735661492  
Fax    
Email  kma.hossain@just.edu.bd  
 
Details of Contact Person
Public Query  
Name  Dr Kazi Md Amran Hossain 
Designation  Lecturer  
Affiliation  Jashore University of Science and Technology 
Address  Room - 302, Department of Physiotherapy and Rehabilitation, Jashore University of Science and Technology, Jashore-7408, Bangladesh



7408
Other 
Phone  8801735661492  
Fax    
Email  kma.hossain@just.edu.bd  
 
Source of Monetary or Material Support  
Department of Physiotherapy and Rehabilitation, Level 2 and 3, Dr. M R Khan Medical Center, Jashore University of Science and Technology, Jashore-7408, Bangladesh 
 
Primary Sponsor  
Name  Dr Ehsanur Rahman 
Address  Room - 401, Department of Physiotherapy and Rehabilitation, Jashore University of Science and Technology, Jashore-7408, Bangladesh 
Type of Sponsor  Other [University] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     Bangladesh  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Md Kabir Hossain  Dr. M R Khan Medical Center  Room - 301, Department of Physiotherapy and Rehabilitation, Musculoskeletal Lab, Jashore University of Science and Technology, Jashore-7408, Bangladesh

 		 8801778315139

kabir2002pt@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IRB of Department of Physiotherapy & Rehabilitation, JUST  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M438||Other specified deforming dorsopathies,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  McKenzie Exercises  Total duration: 4 weeks. Participants in this group will receive the same McKenzie exercise protocol without PRP. They will attend 12 supervised sessions over 4 weeks, performing 10 repetitions of directed lumbar movements (extension, flexion, lateral shifts, rotation) and manipulative therapy (10–15 reps using on-off maneuvers for 5–7 minutes). A home exercise program will be performed 5–7 times per day, for 4 weeks, with 10 reps every 2–3 hours throughout 14 waking hours. 
Intervention  PRP + McKenzie Exercises  Total duration: 4 weeks. This group will receive: PRP Therapy: A single ultrasound-guided transforaminal epidural injection of 2–3 mL of autologous PRP prepared from 26 mL of venous blood using a double-spin centrifugation method (yielding 2–5× baseline platelet concentration). The injection will be performed under aseptic conditions with a 22-gauge, 8-inch Quincke Chiba needle. After ultrasound confirmation of needle placement, 2–3 mL of PRP mixed with 0.5 mL of normal saline will be injected at the affected disc level. McKenzie Exercises: Patients will undergo 12 supervised sessions over 4 weeks. Each session includes 10 repetitions of directed movements (extension, flexion, lateral movements, rotation) and 10–15 repetitions of manipulative therapy for 5–7 minutes. A structured home program will be followed 5–7 times daily for 4 weeks, with 10 reps every 2–3 hours during 14 waking hours. 
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  55.00 Year(s)
Gender  Both 
Details  1. Adults aged 25 to 55 years, both sexes.
2. Clinically diagnosed L5 to S1 lumbar disc herniation confirmed by MRI (disc protrusion or bulge, with or without nerve root compression).
3. Chronic low back pain with or without radiating leg pain, consistent with radiculopathy, for more than 6 weeks.
4. Pain intensity of 3 or above on the Visual Analogue Scale (VAS).
5. Inadequate response to prior conservative treatments (e.g., rest, oral medication, or physiotherapy without supervision).
6. Positive Straight Leg Raise test or neurological signs such as sensory change, weakness, or altered reflex.
7. Platelet count within the normal range (150,000 to 400,000 per microliter).
8. Not currently recommended for surgery or prefers non-surgical treatment.
9. Provides written informed consent to participate. 
 
ExclusionCriteria 
Details  1. Calcified disc herniation or hard disc on imaging
2. Cauda equina syndrome (e.g., urinary retention, saddle anesthesia)
3. Other spinal pathologies, including tumors, spinal infections (e.g., tuberculosis), or vertebral fractures
4. Previous lumbar spine surgery at the affected level
5. Uncontrolled diabetes mellitus
6. Pregnancy
7. Contraindications to PRP or exercises: Bleeding disorders (e.g., haemophilia), Current anticoagulant use (except low-dose aspirin), Severe cardiovascular or neuromuscular comorbidities) 
 
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 
1. Pain by NPRS and PPTs
2. Disc Morphology by disc height, disc echogenicity, and disc displacement (assessed via MSK-USG)
3. Neurological Recovery by SLR, NCS, and EMG 		 Baseline, 1 month, 3 months, and 6 months post-intervention 
 
Secondary Outcome  
Outcome  TimePoints 
Disability by Oswestry Disability Index (ODI)  Baseline, 1 month, 3 months, and 6 months post-intervention 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="0" 
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)   Date Missing 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  15/07/2025 
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 Yet Recruiting 
Recruitment Status of Trial (India)  Not Applicable 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [kma.hossain@just.edu.bd].

  6. For how long will this data be available start date provided 01-02-2026 and end date provided 01-02-2031?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   This randomized controlled trial aims to evaluate the effectiveness of ultrasound-guided platelet-rich plasma (PRP) injection combined with McKenzie exercises compared to McKenzie exercises alone in patients with MRI-confirmed L5/S1 lumbar disc herniation. The study will assess improvements in pain, disc morphology, neurological recovery, and functional disability. Sixty patients will be enrolled and allocated into two groups. The hypothesis is that the combined approach of PRP and physiotherapy will produce superior outcomes in terms of structural and neurophysiological recovery compared to physiotherapy alone. 
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