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CTRI Number  CTRI/2025/07/090664 [Registered on: 10/07/2025] Trial Registered Prospectively
Last Modified On: 04/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Manual therapy for disc prolapse in the lower back 
Scientific Title of Study   Comparing two Manual therapy approaches along with Inpatient medical care for women having Cauda equina syndrome due to Prolapsed lumbar intervertebral disc 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sapia Akter 
Designation  Doctoral student 
Affiliation  Jashore University of Science & Technology  
Address  Room 624, level 4, Department of Nutrition and Food Technology, Jashore University of Science and Technology, Jashore, Bangladesh



7408
Other 
Phone  8801615451526  
Fax    
Email  sapia4515@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Rashida Parvin 
Designation  Associate Professor 
Affiliation  Jashore University of Science & Technology 
Address  Room 624, level 4, Department of Nutrition and Food Technology, Jashore University of Science and Technology, Jashore, Bangladesh



7408
Other 
Phone  8801718729008  
Fax    
Email  rashida.nft@just.edu.bd  
 
Details of Contact Person
Public Query  
Name  Rashida Parvin 
Designation  Associate Professor 
Affiliation  Jashore University of Science & Technology 
Address  Room 624, level 4, Department of Nutrition and Food Technology, Jashore University of Science and Technology, Jashore, Bangladesh



7408
Other 
Phone  8801718729008  
Fax    
Email  rashida.nft@just.edu.bd  
 
Source of Monetary or Material Support  
Centre for Autism and Rehabilitation for Persons with Disabilities (CARD), Agrani academic building, Mohammadpur, Dhaka-1207, Bangladesh will fund the cost of remuneration and the cost of the data collection process.  
 
Primary Sponsor  
Name  Centre for Autism and Rehabilitation for Persons with Disabilities (CARD) 
Address  level 3, ASPC Academic building, Nurjahan Road, Mohammadpur, Dhaka 1207, Bangladesh 
Type of Sponsor  Other [Philanthropic organization in Disability] 
 
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 Mohammad Afzal Hossain  Agrani Specialized Physiotherapy Centre  Inpatient musculoskeletal unit, level 2 and 3, ASPC Manipulation Therapy, U-64, Nurjahan Road, Mohammadpur, Dhaka 1207, Bangladesh

 		 880 1615451527

research@aspc.com.bd 
 
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: M511||Thoracic, thoracolumbar and lumbosacral intervertebral disc disorders with radiculopathy,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Manual therapy in Mechanical diagnosis and therapy MDT concept and medical care  14 days inpatient physiotherapy and 14 days home based exercise in MDT concept 
Intervention  Manual therapy in Structural diagnosis and management SDM concept and medical care  14 days inpatient physiotherapy and 14 days home based exercise in SDM concept 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Female 
Details  Prolapse Lumbar intervertebral disc with cauda equina syndrome diagnosed according to the North American Spine Society guideline, magnetic resonance imaging MRI and willing to be treated in nonsurgical management  
 
ExclusionCriteria 
Details  Participants will be excluded if they underwent surgery for PLID before the recruitment or were referred for surgery after the recruitment, have comorbidities that might affect the outcome as obesity, metabolic disease, uncontrolled hypertension or diabetes, early menopause, degenerative disc disease in MRI, and drop-out or withdrawal of participation within first week of recruitment.  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Primary outcomes of the study will be (1) pain measured by a 10cm visual analogue scale; (2) neurological functions measured by (i) straight leg raise degrees, (ii) dural sign, examination of lumbosacral (iii) dermatome, and (iv) myotome; (3) bladder control evaluated by post-void residual volume of urine by ultrasonography; and (4) pelvic floor muscle strength measured by ActivForce 2™ dynamometer.   Day 1, day 30, and Day 90 
 
Secondary Outcome  
Outcome  TimePoints 
Disability in the Oswestry low back disability index (ODI)  Day 1, Day 30, Day 90 
 
Target Sample Size   Total Sample Size="112"
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   Phase 2 
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="3"
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 [rashida.nft@just.edu.bd].

  6. For how long will this data be available start date provided 01-08-2025 and end date provided 30-12-2030?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   There is a considerable research gap on manual therapy approaches for patients having PLID who choose conservative care, even with mild to moderate neurological impairments. This study aims to compare the effectiveness of two manual therapy approaches on women having CES due to PLID. We will evaluate the outcome of a new approach named Structural diagnosis and management (SDM), compared to the Mechanical diagnosis and therapy (MDT) of the lumbar spine. We planned a Randomized clinical trial (RCT) on 112 women admitted for conservative management of PLID at the inpatient unit of a specialized physiotherapy center. Between August and September 2025, women with PLID who have symptoms of CES attending the Outpatient unit of the center will be screened and invited to participate in the trial. Confirmation of PLID will be made by clinical examination and Magnetic resonance imaging (MRI) of the lumbosacral spine. After obtaining informed consent, patients will be randomly allocated to either the SDM (n=56) or the MDT (n=56) groups on two different floors of the facility. Both groups will receive two different manual therapy concepts targeting lumbar paravertebral structures in two sessions every day, each lasting 30-45 minutes at the inpatient unit for 14 days. In addition, both groups will receive medications, nursing care, and nutritional advice from a multidisciplinary team. Both groups will also receive customized home exercises for another 2 weeks after discharge from the inpatient care facility.  We will follow the ethical standards of good clinical practice (ICH-GCP) and adhere to the Consolidated Standards of Reporting Trials (CONSORT). To ensure the rigor of the trial, we will ensure a separate trial and data management team, conduct block randomization during concealed allocation, and ensure appropriate monitoring and reporting of the adverse events and surgical referral.   
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