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CTRI Number  CTRI/2025/07/091418 [Registered on: 22/07/2025] Trial Registered Prospectively
Last Modified On: 18/07/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effect of Corrective breathing exercises in reducing the pain and improving breathing using ultrasound scanning of chest in neck pain individuals with affected breathing motion. 
Scientific Title of Study   Effect Of Breathing Retraining On Pain And Diaphragmatic Excursion Using Ultrasound Measurements In Chronic Non-Specific Neck Pain Individuals With Breathing Pattern Dysfunction. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Bavithra Raja  
Designation  PhD-Scholar 
Affiliation  Manipal Academy of Higher Education  
Address  Upper basement, Department of Physiotherapy, Manipal Hospital, No 98, Rustam Bagh, Old Airport Road, Bangalore, Karnataka 560017,India

Bangalore
KARNATAKA
560017
India 
Phone  9047221917  
Fax    
Email  bavithra.mhsblr2024@learner.manipal.edu  
 
Details of Contact Person
Scientific Query  
Name  Dr Karvannan H  
Designation  Head and Associate Professor  
Affiliation  Manipal Academy of Higher Education  
Address  Department of Physiotherapy, Manipal Hospital #98, HAL, Old Airport Road, Bangalore Karnataka 560017, India

Bangalore
KARNATAKA
560017
India 
Phone  9986565966  
Fax    
Email  karvannan.h@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Dr Karvannan H  
Designation  Head and Associate Professor  
Affiliation  Manipal Academy of Higher Education  
Address  Department of Physiotherapy, Manipal Hospital #98, HAL, Old Airport Road, Bangalore Karnataka 560017, India

Bangalore
KARNATAKA
560017
India 
Phone  9986565966  
Fax    
Email  karvannan.h@manipal.edu  
 
Source of Monetary or Material Support  
Department of Physiotherapy, Manipal College of Health Professions, Manipal Hospitals Bangaglore,No.98, Rustam Bagh Road, Old Airport Road, Bangalore 560017. 
 
Primary Sponsor  
Name  Manipal Academy of Higher Education  
Address  Department of Physiotherapy, Manipal Hospitals, Bangalore #98, HAL, Old Airport Road, Bangalore, Karnataka 560017  
Type of Sponsor  Research institution and hospital 
 
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 Bavithra Raja  Manipal hospitals  Department of Physiotherapy, Manipal College of Health Professions, Manipal Hospitals Bangaglore,No.98, Rustam Bagh Road, Old Airport Road, Bangalore 560017.
Bangalore
KARNATAKA 		 9047221917

bavithra.mhsblr2024@learner.manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethical Committee of Manipal Hospital, Bangalore   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M953||Acquired deformity of neck,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Breathing exercise and conventional therapy  1.Duration of treatment (Breathing exercise and conventional therapy)- 30-45 minutes per session for 3 sessions per week for 4 week of supervised sessions (12 sessions), followed by 4-8 weeks of unsupervised sessions (12 sessions). 2.Breathing exercise-diaphragmatic breathing exercise Repetition:3 sets for 10-15 minutes, five repetition in each set lasted for 3 minutes with a rest of 2 minutes between each set. 3.conventional therapy includes Manual therapy includes cervical mobilization and Integrated neuromuscular inhibition technique Duration: each technique will be applied for 1-2 minutes. Exercise regime includes Warm up:5 mins, Activity: 15-20 mins and Cool down: 5-10 mins  
Intervention  Breathing retraining and conventional therapy  1.Duration of the treatment (Breathing retraining and conventional therapy): 30-45 minutes per session for 3 sessions per week for 4 week of supervised sessions (12 sessions), followed by 4-8 weeks of unsupervised sessions (12 sessions). 2.Breathing retraining- four steps which includes Awareness of faulty breathing Relaxing the upper thorax Activation abdominal/ lower lateral coastal Normalize the breathing pattern Repetition:3 sets for 10-15 minutes, each set lasted for 3 minutes with a rest of 2 minutes between each set 3.Conventional therapy includes: Manual therapy, exercise, patient education and exercise. Manual therapy includes cervical mobilisation and Integrated neuromuscular inhibition technique Duration: each technique will be applied for 1-2 min Exercise regime includes Warm up:5 mins, Activity: 15-20 mins and Cool down: 5-10 mins.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  55.00 Year(s)
Gender  Both 
Details  Patients with Chronic Non-Specific Neck Pain for more than 3 months
Pain intensity of 3-7 in NPRS
patients with Forward Neck Posture of CVA less than 50 degree
Patients with Breathing Pattern Dysfunction using SEBQ score more than 11 
 
ExclusionCriteria 
Details  Patient with BMI more than 30.
pregnant women.
neoplasm.
patients with co-ordination and balance dysfunction.
Patients with Neurological deficit.
Neck pain associated with Headache.
Individuals who underwent cervical spine surgery, any chest wall surgeries, and abdominal surgeries.
Individuals with chest wall, spinal skeletal deformities.
Individuals with any pulmonary pathology.
Individuals with Gastro oesophageal reflex disease.
Individuals with severe psychological disorder like depression, panic attacks, schizophrenia
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Pain and Diaphragmatic Excursion  pain- At baseline (0 week), 4th week, end of treatment (8th week)
Diaphragmatic excursion-At baseline (0 week), end of the treatment (8th week) 
 
Secondary Outcome  
Outcome  TimePoints 
Neck disability index  At baseline (0 week), 4th week, end of treatment (8th week) 
Self evaluation breathing questionnarie   At baseline (0 week), 4th week, end of treatment (8th week) 
Manual assessment of respiratory motion  At baseline (0 week), 4th week, end of treatment (8th week) 
Cervical Range of Motion  At baseline (0 week), 4th week, end of treatment (8th week) 
Respiratory rate  At baseline (0 week), 4th week, end of treatment (8th week) 
CVA angle  At baseline (0 week) 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
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)   21/09/2025 
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="2"
Months="6"
Days="0" 
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   chronic non-specific neck pain is unspecified neck pain without particular underlying condition and pain intensity will last for more than three months. Patients with chronic neck pain found to have altered respiratory pattern because of overactivation of neck and thoracic muscle, restricted cervico-thoracic mobility and postural imbalances which results in changes the biomechanics of the breathing often leading to dysfunction of the diaphragm which ultimately causes breathing pattern dysfunction. traditional conventional therapy for neck pain have showed a significant results pain and disability, for effective management combining the  breathing retraining with conventional therapy will have beneficial outcome. breathing retraining focus on altering the dysfunctional pattern and activating the respiratory muscle in resting position and functional movements can help reducing the pain and restore the normal respiratory biomechanics. This randomized controlled trial aims to evaluate the effect of Breathing retraining on pain and diaphragmatic excursion using ultrasound measurements in Chronic non-specific neck pain individuals with breathing patten dysfunction.  
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