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CTRI Number  CTRI/2024/10/075999 [Registered on: 28/10/2024] 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 Trial 
Public Title of Study   effect of deep breathing exercise with exercise therapy on non-specific low back pain 
Scientific Title of Study   Effects of deep breathing exercises with exercise therapy on Non-specific low back pain: A randomized controlled trial. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Munavvir V A 
Designation  PG student 
Affiliation  Yenepoya Physiotherapy College 
Address  MPT second year student, Physiotherapy Department, Yenepoya Physiotherapy College, Naringana,Mangalore,Dakshina kannada,karnataka,575018

Dakshina Kannada
KARNATAKA
575018
India 
Phone  9744256275  
Fax    
Email  Munavirva7@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Saloni Shetty 
Designation  Assistant Professor,Yenepoya Physiotherapy College 
Affiliation  Yenepoya Physiotherapy College 
Address  Physiotherapy department, Yenepoya Physiotherapy College, naringana, Mangalore,Dakshina kannada,karnataka,575018

Dakshina Kannada
KARNATAKA
575018
India 
Phone  9482135919  
Fax    
Email  salonishetty@yenepoya.edu.in  
 
Details of Contact Person
Public Query  
Name  Saloni Shetty 
Designation  Assistant Professor,Yenepoya Physiotherapy College 
Affiliation  Yenepoya Physiotherapy College 
Address  Physiotherapy department, Yenepoya Physiotherapy College, naringana, Mangalore,Dakshina kannada,karnataka,575018

Dakshina Kannada
KARNATAKA
575018
India 
Phone  9482135919  
Fax    
Email  salonishetty@yenepoya.edu.in  
 
Source of Monetary or Material Support  
Principal Investigator,Yenepoya Physiotherapy College,Yenepoya Deemed to be University,Derlekette,Mangalore,575018 
 
Primary Sponsor  
Name  Munavvir V A 
Address  Yenepoya Physiotherapy College,Naringana, Mangalore, Karnataka, 575018 
Type of Sponsor  Other [Self] 
 
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 Munavvir V A PT   Yenepoya Medical College and Hospital  Physiotherapy Depaartment,7th floor,Derlekette,Mangalore,Dakshina kannada,Karnataka,575018
Dakshina Kannada
KARNATAKA 		 9744256275

Munavirva7@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Yenepoya Ethics Committee-1  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M00-M99||Diseases of the musculoskeletal system and connective tissue,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Deep Breathing Exercise and McKenzie Exercise Therapy   Participants in the intervention group will perform a combination of deep breathing exercises and McKenzie exercise therapy. Sessions will start with deep breathing to promote relaxation, followed by McKenzie exercises like prone press-ups, plank, and superman, performed for 10 repetitions by 2 sets. The program lasts 2 weeks, with sessions of 40-45 minutes, including one session at the OPD and a second session at home, guided via phone.  
Comparator Agent  McKenzie Exercise Therapy Alone   The control group will perform only McKenzie exercises (e.g., prone press-ups, plank, superman), tailored to the condition’s severity, with 10 repetitions by 2 sets. The program lasts 2 weeks, with a similar session structure to the intervention group (OPD and home-based). 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Participants must have experienced low back pain in the past 3 weeks, be of all genders, and be 18 years or older.
 
 
ExclusionCriteria 
Details  Individuals with any age-related co-morbidities that may interfere with therapy, those unable to participate in therapy sessions due to physical or psychological limitations, participants with known allergies or sensitivities that could affect their ability to engage in the study, and individuals with a history of substance abuse issues will be excluded from the study. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Visual Analogue Scale  Pre-Intervention and 2 Weeks Post Intervention 
 
Secondary Outcome  
Outcome  TimePoints 
Modified-Modified Schober test  Pre-Intervention and 2 Weeks Post Intervention 
 
Target Sample Size   Total Sample Size="42"
Sample Size from India="42" 
Final Enrollment numbers achieved (Total)= "42"
Final Enrollment numbers achieved (India)="42" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   10/11/2024 
Date of Study Completion (India) 06/06/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 06/06/2025 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Completed 
Recruitment Status of Trial (India)  Completed 
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  
This randomized controlled trial aims to evaluate the effectiveness of a combined intervention of deep breathing exercises and exercise therapy in reducing non-specific low back pain compared to exercise therapy alone. Participants, who have experienced low back pain in the past three weeks, will be randomly assigned to either the intervention group, receiving deep breathing exercises along with a McKenzie exercise therapy program, or the control group, which will receive only McKenzie exercise therapy. The 2-week program will consist of 40-45 minute sessions, with exercises tailored to individual needs. The primary outcome will be the reduction in pain levels, assessed using appropriate pain scales, while secondary outcomes may include functional improvement and quality of life measures. This study seeks to provide evidence on the efficacy of integrating deep breathing exercises into conventional exercise therapy for patients with non-specific low back pain, potentially enhancing treatment outcomes and patient quality of life.

 
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