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CTRI Number  CTRI/2025/12/098646 [Registered on: 08/12/2025] Trial Registered Prospectively
Last Modified On: 06/12/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Single Arm Study 
Public Title of Study   Effect of Breath Retraining on pain, neck problems and respiratory functions in young adults with neck pain. 
Scientific Title of Study   Effect of Breath Retraining on pain, cervical Disability and Pulmonary functions in Young adult with non-specific chronic Neck pain - A Quasi Experimental Study.  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Vaishnavi Kale 
Designation  Intern 
Affiliation  Modern college of physiotherapy 
Address  Department of Musculoskeletal Physiotherapy, OPD, PES Modern college of physiotherapy Shivaji Nagar Pune-05
Department of Musculoskeletal Physiotherapy, OPD, PES Modern college of physiotherapy Shivaji Nagar Pune-05
Pune
MAHARASHTRA
411005
India 
Phone  8805084782  
Fax    
Email  vaishnavikale075@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Shruti Mankar 
Designation  Assistant Professor 
Affiliation  Modern college of physiotherapy 
Address  Department of Cardiovascular & Respiratory Physiotherapy, PES Modern college of physiotherapy Shivaji Nagar Pune -05
Department of Cardiovascular & Respiratory Physiotherapy, PES Modern college of physiotherapy Shivaji Nagar Pune -05
Pune
MAHARASHTRA
411005
India 
Phone  7276020635  
Fax    
Email  mankarshrutee@gmail.com  
 
Details of Contact Person
Public Query  
Name  Vaishnavi Kale 
Designation  Intern 
Affiliation  Modern college of physiotherapy 
Address  PES Modern college of physiotherapy Shivaji Nagar pune05
PES Modern college of physiotherapy Shivaji Nagar pune05
Pune
MAHARASHTRA
411005
India 
Phone  8805084782  
Fax    
Email  vaishnavikale075@gmail.com  
 
Source of Monetary or Material Support  
PES Modern College of Physiotherapy OPD, PES Modern College of Physiotherapy,Pune -05. 
 
Primary Sponsor  
Name  nil 
Address  nil 
Type of Sponsor  Other [nil] 
 
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 
Vaishnavi kale  PES modern college of physiotherapy  PES Modern College Out Patient Department, Department of Musculoskeletal Physiotherapy, PES modern college of physiotherapy modern college engineering road Shivajinagar, Pune- 411005
Pune
MAHARASHTRA 		 8805084782

vaishnavikale075@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics Committee PES Modern College of Physiotherapy  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Non-specific chronic neck pain 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Breath Reeducation  Breath reeducation has following components Relaxed supported posture Slow relaxed breathing Diaphragmatic breathing breath retraining exercises has shown effect on increasing cervical muscle activation and respiratory function. exercises for three times per week for four weeks. session for 15 to 20 minutes 
Comparator Agent  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  25.00 Year(s)
Gender  Both 
Details  Patients with non-specific chronic neck pain.
Patients in the age group 18-25 years.
both male as well as female.
Patients with pain in range of 5 to 7 on NPRS.
Neck disability index score with moderate disability.
 
 
ExclusionCriteria 
Details  Post traumatic neck pain.
Patient with smoking
Patient with allergic asthma
musculoskeletal conditions like spondylosis, Cervical radiculopathy, cervical scoliosis.
Patients on medications
Pregnancy and breastfeeding women.
People who are doing gym 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
NPRS
Neck disability index
PFT - FEV1, FVC, FEV1/FVC 		 All outcomes will be assessed on baseline & at the end of Week 4. 
 
Secondary Outcome  
Outcome  TimePoints 
Nil  Nil 
 
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)   17/12/2025 
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="0"
Months="5"
Days="30" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
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  
The purpose of this study is to investigate the effect of breath retraining on several key outcomes in young adults diagnosed with non-specific chronic neck pain.
Specifically, the study will measure changes in Pain intensity, Cervical disability, which refers to how much the neck pain interferes with daily activities and Pulmonary function, which assesses lung capacity and performance.
By comparing outcomes before and after a period of breath retraining, this research aims to determine if this simple intervention can be an effective adjunctive treatment to improve pain, neck function, and breathing mechanics in this young adult population. The ultimate goal is to establish evidence for non-pharmacological approaches to managing chronic neck pain. The study is recruiting 40 participants age 18–25 years with non-specific chronic neck pain and a pain score of 5 to 7 on the Numerical Pain Rating Scale . The intervention consisted of breath retraining has 3 components that is Relaxed supported posture, Slow relaxed breathing and Diaphragmatic breathing administered twice a day, three alternate days a week, for four weeks. Outcome measures assessed pre- and post-intervention will be Pain on numerical pain rating scale, Cervical Disability on Neck Disability Index, and Pulmonary Function on FEV1, FVC and ratio of FEV1 and FVC.
 
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