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CTRI Number  CTRI/2024/08/071787 [Registered on: 01/08/2024] Trial Registered Prospectively
Last Modified On: 21/07/2025
Post Graduate Thesis   
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effectiveness of Structured Systematic Exercise Program on Physical Activity Level for Subjects with Chronic Lumbar Disc Herniation 
Scientific Title of Study   Structured Systematic Exercise Program for Subjects with Chronic 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  Vinod Babu K 
Designation  PhD Physiotherapy Research Scholar 
Affiliation  Padmashree Institute of Physiotherapy 
Address  Padmashree Institute of PhysiotherapyNo 149, Padmashree Campus, Sulikere Post, Kommaghatta, Bangalore, Karnataka. Pin code- 560060
S/o R Krishnappa, Beside Dharmaraya Swamy (Karaga) Temple, BhagathSingh Nagar 3rd Cross, behind Prasanthi Bala Mandir School, Chikkaballapur Town, Chickballapur District Karnataka. Pin code-562101
Kolar
KARNATAKA
560060
India 
Phone  9060934046  
Fax    
Email  vinodbabupt@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Vinod Babu K 
Designation  PhD Physiotherapy Research Scholar 
Affiliation  Padmashree Institute of Physiotherapy 
Address  Padmashree Institute of PhysiotherapyNo 149, Padmashree Campus, Sulikere Post, Kommaghatta, Bangalore, Karnataka.Pin code- 560060
S/o R Krishnappa, Beside Dharmaraya Swamy (Karaga) Temple, BhagathSingh Nagar 3rd Cross, behind Prasanthi Bala Mandir School, Chikkaballapur Town, Chickballapur District Karnataka. Pin code-562101
Kolar
KARNATAKA
560060
India 
Phone  9060934046  
Fax    
Email  vinodbabupt@gmail.com  
 
Details of Contact Person
Public Query  
Name  Vinod Babu K 
Designation  Phd Physiotherapy Research Scholar 
Affiliation  Padmashree Institute of Physiotherapy 
Address  Padmashree Institute of PhysiotherapyNo 149, Padmashree Campus, Sulikere Post, Kommaghatta, Bangalore, Karnataka.Pin code 560060
S/o R Krishnappa, Beside Dharmaraya Swamy (Karaga) Temple, BhagathSingh Nagar 3rd Cross, behind Prasanthi Bala Mandir School, Chikkaballapur Town, Chickballapur District Karnataka. Pin code-562101
Kolar
KARNATAKA
560060
India 
Phone  9060934046  
Fax    
Email  vinodbabupt@gmail.com  
 
Source of Monetary or Material Support  
Padmashree Institute of Physiotherapy, No 149, Padmashree Campus, Sulikere Post, Kommaghatta, Kengeri, Bangalore, Karnataka 560060  
 
Primary Sponsor  
Name  VINOD BABU K 
Address  Padmashree Institute of Physiotherapy No 149, Padmashree Campus, Sulikere Post, Kommaghatta, Kengeri, Bangalore, Karnataka 560060 
Type of Sponsor  Other [Self Funding] 
 
Details of Secondary Sponsor  
Name  Address 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Vinod Babu K  Padmashree Institute of Physiotherapy  No 149, Padmashree Campus, Sulikere Post, Kommaghatta, Kengeri, Bangalore, Karnataka 560060
Bangalore
KARNATAKA 		 9060934046

vinodbabupt@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Padmashree Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M518||Other thoracic, thoracolumbar andlumbosacral intervertebral disc disorders,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Conventional exercises   Conventional exercises for a period of 6 weeks 
Intervention  Structured Systemic Exercise Program  Structured Systemic Exercise Program. The exercise program will be given for a period of 6 weeks. 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  1. Age group between 30 to 50 years.
2. Gender- both male and female.
3. Subjects referred by Orthopaedic surgeons, and neurosurgeons who initially have diagnosed the pathological condition involvement of LDH at the level of L4-L5, L5-S1, or L4-L5+L5-S1 based on correlation with MRI.
4. Chronic Lumbar disc herniation pain with duration of more than 3 months of onset.
5. Lower back pain without referred pain to limbs or with referred pain to the legs/buttock region, or manifest as a combination of both.
6. Clinical factors at baseline with any of the findings: a. Visual Analog scale legs/buttock region pain less than 7.0. b. Visual Analog scale back pain less than 7.0, c. Oswestry Disability Index score of at least 30 out of 100 points, d. Positive straight leg rises above 60 degree. 
 
ExclusionCriteria 
Details  1. Subjects with having neurological impairments (red flags signs) like Muscle weakness, loss of sensation, impaired reflexes, Cauda equina syndrome or progressive motor deficit.
2. Subjects with history of having fracture of lumbar spine or Spondylolisthesis.
3. Subjects having spinal tumour or malignancy or TB in their spine.
4. Subjects with history lumbar spine surgery.
5. Subjects having spinal deformity like Scoliosis, Kyphosis or Spina bifida etc.
6. Subjects with Neurogenic claudication reduced walking distance and neurologic signs.
7. Subjects with neuropathic pain, shows positive tests of hypersensitivity to non-noxious (allodynia) and noxious stimuli (hyperalgesia).
8. Subjects with Inflammatory disease, Vestibular condition.
9. Subjects present with any Musculoskeletal condition that limit mobility like severe arthritis, trauma, fracture, surgery etc
10. Subjects who are unwilling to participate. 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1.Physical activity measurement.  Baseline and after 6 weeks of intervention. 
 
Secondary Outcome  
Outcome  TimePoints 
2.Low back pain intensity will be measured using visual analogue scale
3.Mobility: Neural tension using straight-leg-raising test in degrees & Lumbo-pelvic-hip complex motion using in centimetre. 		 Baseline & after 6 weeks of intervention 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   19/08/2024 
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)
Modification(s)  		 Not Applicable 
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 - NO
Brief Summary  

Aims and Objective of the study

Aim: To determine the effectiveness of structured systematic exercise program on level of physical activity for subjects with chronic lumbar disc herniation. 

Objectives:

1.      To evaluate the level of Physical activity among subjects with chronic lumbar disc herniation.

2.      To establish a structured systematic exercise program on Physical activity for subjects with chronic lumbar disc herniation.

3.      To evaluate the rate of compliance of developed structured systematic exercise program for improving Physical activity in subjects with chronic lumbar disc herniation.

4.      To evaluate the effect of structured systematic exercise program on Physical activity in subjects with chronic lumbar disc herniation.


METHODOLOGY OF THE STUDY CONDUCTED IN FOUR PHASES OR PARTS

Part-1 of the study consists of evaluation of Physical activity level among chronic lumbar disc herniation.

The level of Physical activity will be measured using accelerometer and IPAQ Short Form (International Physical Activity Questionnaire).

Part-2 Establishing structured/therapeutic program on Physical activity for subjects with chronic lumbar disc herniation.A systematic review on therapeutic programs or physiotherapy interventions for

Physical Activity in chronic disc herniation will be conducted.  Based on the systematic review a therapeutic program will be established.

The standardization and validation of therapeutic program will be carried by Delphi survey to establish consensus opinion among 30 subject experts physiotherapist who having experience in using exercise to treat people with Chronic lumbar disc herniation.

An electronic questionnaire by Google form will be used to collect experts opinions. Consensus will be defined as when 70% of the experts agreed or disagreed with an item. The strength of agreement or disagreement will be evaluated through grading of responses with a Likert response scale. Likert response scale questions. The number of responses of “strongly agree,” “agree,” or “somewhat agree” will be summated and expressed as a percentage of agreement. Similarly, the number of responses of “strongly disagree,” “disagree,” or “somewhat disagree” will be summated and expressed as a percentage of disagreement.

Part-3 Evaluating the Rate of compliance of developed Structured program on Physical activity in chronic disc herniation.

A study will be conducted to find the rate of compliance to types, intensity of exercises. The study will be designed with an objective to measures the rate of compliance of established structured exercise program.

Part-4 Evaluation of effect of Structured/therapeutic program on Physical activity in chronic disc herniation.

Screening will be done on the basis of inclusion and exclusion criteria for both the groups. The eligible patient will be allotted into group A and B by Block Randomisation.

Group A (Experimental group): The treatment group will undergo Structured/therapeutic program for duration 6 weeks of intervention.

Group B (Control group): The control group will undergo conventional exercises for duration 6 weeks of intervention.
 
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