| CTRI Number |
CTRI/2024/11/077142 [Registered on: 20/11/2024] Trial Registered Prospectively |
| Last Modified On: |
09/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
analyzing the movement of breathing changes in prolonged neck patients and normal individuals |
|
Scientific Title of Study
|
Analysis breathing pattern dysfunction in patients with non-specific chronic neck pain and healthy individual -A Cross-sectional 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 |
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
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 Hospital #98, HAL, Old Airport Road, Bangalore, Karnataka 560017 |
|
|
Primary Sponsor
|
| Name |
Manipal Academy of Higher Education |
| Address |
Manipal Comprehensive Spine Care Center, Manipal Institute of Robotic Spine Surgery, Manipal Hospitals, Bangalore #98, HAL, Old Airport Road, Bangalore, Karnataka 560017 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Bavithra Raja |
Manipal Hospitals |
Ground Floor, Manipal Comprehensive Spine Care Center, Manipal Institute of Robotic Spine Surgery. Manipal Hospitals Bangalore, #98, HAL, Old Airport Road, Bangalore, Karnataka 560017, India
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M953||Acquired deformity of neck, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
nil |
nil |
|
|
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
patients with Forward Neck Posture of CVA more than 45 degree
Patients with Breathing Pattern Dysfunction |
|
| ExclusionCriteria |
| Details |
Patients with co-ordination and balance dysfunction
Patients with Neurological deficit
Neck pain associated with Headache
Patients who underwent cervical spine surgery
Patients with Psychological involvement |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Diaphragmatic motion measurement using USG |
Immediate observation only at baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Neck Disability Index |
Immediate observation only at baseline |
| Nijmegen Questionnaire |
Immediate observation only at baseline |
| MARM (Manual Assessment of Respiratory Motion) |
Immediate observation only at baseline |
| Cranio-Vertebral Angle |
Immediate observation only at baseline |
| Numerical Pain Rating Scale |
Immediate observation only at baseline |
| Cervical Range of Motion |
Immediate observation only at baseline |
|
|
Target Sample Size
|
Total Sample Size="176"
Sample Size from India="176"
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)
|
12/12/2024 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Respiratory functions has been found to be decrease in chronic neck pain patients due to
reduce in activity of local muscles because of severe pain and increased disability levels. Alteration of cervicothoracic mobility impairs normal breathing mechanics by reducing
diaphragm mobility and strength have a marked impact on quality of life and well as functionality of the patients. |