| CTRI Number |
CTRI/2025/02/081294 [Registered on: 25/02/2025] Trial Registered Prospectively |
| Last Modified On: |
25/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical study to see the benefit of inspiratory muscle strengthening and relaxation techniques in chest pain patient without cardiac causes |
|
Scientific Title of Study
|
Effect of Diaphragmatic breathing,Dynamic neural stabilization and Jacobsons relaxation techniques on Gastrointestinal and Psychological causes of non-cardiac chest pain |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Anusha suryavanshi |
| Designation |
Post Graduate students |
| Affiliation |
Manipal College Of Health Professions |
| Address |
Upper Basement,# 98 , HAL, Old Airport Road ,Department of physiotherapy, Manipal college of health professionals,
Manipal hospital, Bengaluru
Upper Basement, # 98, HAL, Old Airport Road , Department of physiotherapy, Manipal college of health professionals,
Manipal hospital, Bengaluru
Bangalore
KARNATAKA
560017
India |
| Phone |
9738209620 |
| Fax |
|
| Email |
anusha.mhsblr2022@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
DrVPrem |
| Designation |
HOD and Associate Professor , Department of physiotherapy |
| Affiliation |
Manipal College Of Health Professions |
| Address |
Upper Basement , #98, HAL, Old Airport Road, Department of physiotherapy, Manipal college of health professionals,
Manipal hospital, Bengaluru
Upper Basement , #98, HAL, Old
Airport Road ,Department of physiotherapy, Manipal college of health professionals,
Manipal hospital, Bengaluru
Bangalore
KARNATAKA
560017
India |
| Phone |
9886647732 |
| Fax |
|
| Email |
prem.v@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
DrVPrem |
| Designation |
HOD and Associate Professor , Department of physiotherapy |
| Affiliation |
Manipal College Of Health Professions |
| Address |
Upper Basement , #98, HAL, Old Airport Road, Department of physiotherapy, Manipal college of health professionals,
Manipal hospital, Bengaluru
Upper Basement , #98, HAL, Old
Airport Road ,Department of physiotherapy, Manipal college of health professionals,
Manipal hospital, Bengaluru
Bangalore
KARNATAKA
560017
India |
| Phone |
9886647732 |
| Fax |
|
| Email |
prem.v@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Upper Basement , #98 , HAL, Old Airport Road ,Department of physiotherapy, Manipal college of health professionals,
Manipal hospital, Bengaluru
|
|
|
Primary Sponsor
|
| Name |
Manipal College Of Health Professions |
| Address |
Upper Basement, #98, HAL, Old Airport Road ,Department of physiotherapy, Manipal college of health professionals,
Manipal hospital, Bengaluru
|
| 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 |
| DrAnusha suryavanshi |
Manipal Hospital |
first floor Cardiology OPD Manipal Hospital , Old Airport Road , HAL , Bangalore
Bangalore
KARNATAKA |
9738209620
anusha.mhsblr2022@learner.manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee of Manipal Hospital,Bangalore |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K928||Other specified diseases of the digestive system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Diaphragmatic breathing , Jacobsons relaxation technique, Dynamic neuromuscular stabilization
|
Diaphragmatic breathing is advised thrice a week for 4 weeks
Jacobsons relaxation technique is advised for 10-15 mins per day for 3 days per week for 4 weeks.
Dynamic neuromuscular stabilization exercises is fine 10 repetition per day for 4 weeks |
| Comparator Agent |
medial management |
no exercise intervention , only the medical management for the underlying diagnosis |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Subjects presenting to the cardiology department with chest pain and being diagnosed as a case of Non-cardiac chest pain by the physician or cardiologist
Both male and female
Age group recruited were all adults above 18 years of age
Subjects who understood English
|
|
| ExclusionCriteria |
| Details |
Acute myocardial infraction patient
history of trauma to thorax
A rise/ fall pattern of cardiac troponin and values including myocardial injury
Patient diagnosed with Alzheimers and dementia
history of spinal surgery
|
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Beck’s depression inventory
Hamilton depression rating scale
Gerd- health-related QOL
MARM
|
They will be assessed at baseline and after 4 week of regular intervention
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Manual assessment of respiratory movement |
at baseline |
|
|
Target Sample Size
|
Total Sample Size="88"
Sample Size from India="88"
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)
|
08/03/2025 |
| 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="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
|
This study is a randomized controlled trial study ,to see the effectiveness of diaphragmatic breathing exercise, Jacobson’s relaxation technique and dynamic neuromuscular stabilization on patient with Non cardiac chest pain with gastrointestinal and psychological cause from Cardiology opd , Manipal hospital , Old Airport Road , HAL , Bangalore. The study will target a sample of 44 individuals per group that is in both control and intervention group. The individuals will be recruited from the cardiology opd by the diagnosis of non cardiac chest pain from the cardiologist . The individuals will be randomized by systematic random sampling method in control and intervention group equally. The primary outcome measures used are Beck’s depression inventory, Hamilton’s depression rating scale and GERD health related quality of life questionnaire. The intervention group will be given the exercise plan along with the medication prescribed if any; the control group will be given prescribed medication if any. After 4 weeks both the groups will be assessed again using the outcome measure and check the effectiveness of exercise in comparison to the control group who were not given the exercise plan and see in any improvement in terms of pain. |