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CTRI Number  CTRI/2025/07/090649 [Registered on: 10/07/2025] Trial Registered Prospectively
Last Modified On: 10/07/2025
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   The Effect of McKenzie Therapy on Lower Back Pain and Nerve Health 
Scientific Title of Study   Effectiveness of Mechanical Diagnosis and Therapy 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  Mahmudul Haque Udoy 
Designation  Undergraduate 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  8801740757573  
Fax    
Email  mhudoy25@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  8801735661477  
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  8801735661477  
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: M439||Deforming dorsopathy, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Conventional Physiotherapy  Total duration: 4 weeks. Participants in this group will receive conventional physiotherapy treatments comprising manual therapy (spinal and soft tissue mobilizations for 20–30 minutes per session), core stabilization exercises (pelvic tilts, bridges, and planks; 2–3 sets of 10–15 repetitions, 10–15 minutes per session), and modalities including moist heat packs for 15–20 minutes (2–3 times daily) and TENS for 20–30 minutes (1–2 times daily). Ergonomic training including posture correction and activity modification will be provided in each session. Participants will attend a total of 12 supervised sessions (3 times per week) over 4 weeks. 
Intervention  McKenzie (MDT) Exercises  Total duration: 4 weeks. Participants in this group will receive supervised Mechanical Diagnosis and Therapy (MDT), also known as McKenzie exercises. Each session will be individualized based on directional preference and will include 10 repetitions of prescribed lumbar movements (extension, flexion, lateral gliding, and rotation), accompanied by therapist-guided manual overpressure techniques (10–15 repetitions using on-off maneuvers for 5–7 minutes per session). Participants will attend 12 supervised sessions (3 times per week) over 4 weeks. A structured home exercise program will be followed, performing prescribed movements for 10 repetitions every 2–3 hours, approximately 5–7 times daily during waking hours, for the entire 4-week period. 
 
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. Not currently recommended for surgery or prefers non-surgical treatment.
8. Provides written informed consent to participate. 
 
ExclusionCriteria 
Details  1. Patients diagnosed with calcified or hard disc herniation confirmed by MRI.

2. Symptoms indicating Cauda Equina Syndrome (e.g., urinary retention, saddle anaesthesia).

3. Presence of other spinal pathologies such as tumors, infections (e.g., tuberculosis), or vertebral fractures.

4. History of previous lumbar spine surgery at the affected level (L5/S1).

5. Participants with uncontrolled diabetes mellitus.

6. Pregnant women or those planning pregnancy during the study period.

7. Participants with medical contraindications to exercise, including bleeding disorders, active anticoagulant therapy (excluding low-dose aspirin), and severe cardiovascular or neuromuscular conditions. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
1. Pain by VAS 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  		 4 weeks 
 
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)  26/07/2025 
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 01-01-2026 and end date provided 31-12-2062?
    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 Mechanical Diagnosis and Therapy also known as McKenzie exercises compared to conventional physiotherapy in patients with L5 S1 lumbar disc herniation. The primary purpose is to investigate whether McKenzie exercises significantly improve disc morphology, neurophysiological parameters, pain intensity, and functional status compared to conventional physiotherapy interventions. The hypothesis is that McKenzie exercises will result in superior clinical outcomes including improved disc morphology and neurophysiology reduced pain intensity and enhanced functional ability relative to conventional physiotherapy treatment. 
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