| CTRI Number |
CTRI/2024/03/064301 [Registered on: 18/03/2024] Trial Registered Prospectively |
| Last Modified On: |
18/03/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of Neck Manipulation on Heart Rate Changes |
|
Scientific Title of Study
|
Immediate Effect of Axis (C2) Manipulation on Heart Rate Variability |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Garima Arya |
| Designation |
Student |
| Affiliation |
Guru Jambheshwar University of Science and Technology Hisar |
| Address |
Department of Physiotherapy Guru Jambheshwar University of Science and Technology Hisar
Hisar
HARYANA
125001
India |
| Phone |
7206081052 |
| Fax |
|
| Email |
aryagarima0701@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manoj Malik |
| Designation |
Assistant Professor |
| Affiliation |
Guru Jambheshwar University of Science and Technology Hisar |
| Address |
Department of Physiotherapy Guru Jambheshwar University of Science and Technology Hisar
Hisar
HARYANA
125001
India |
| Phone |
9896221262 |
| Fax |
|
| Email |
malik_manoj@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Manoj Malik |
| Designation |
Assistant Professor |
| Affiliation |
Guru Jambheshwar University of Science and Technology Hisar |
| Address |
Department of Physiotherapy Guru Jambheshwar University of Science and Technology Hisar
Hisar
HARYANA
125001
India |
| Phone |
9896221262 |
| Fax |
|
| Email |
malik_manoj@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Department of Physiotherapy
Guru Jambheshwar University of Science and Technology,Hisar |
|
|
Primary Sponsor
|
| Name |
Department of Physiotherapy |
| Address |
Department of Physiotherapy Guru Jambheshwar University of Science and Technology Hisar |
| Type of Sponsor |
Research institution |
|
|
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 |
| Dr Manoj Malik |
Department of Physiotherapy |
Room no.5,OPD Guru Jambheshwar University of Science and Technology,Hisar
Hisar
HARYANA |
9896221262
aryagarima0701@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of Guru Jambheshwar University of Science and Technology Hisar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Normal Individuals |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | Axis(C2) Manipulation | (Procedure Reference: , Procedure details: Subjects are to be given cervical neck manipulation. Change in heart rate variability is to be recorded and measured pre and post intervention i.e. before and after axis manipulation.))
| | 2 | Intervention Arm | Procedure | - | Axis (C2) Manipulation | (Procedure Reference: , Procedure details: Subjects are to be given Cervical spine manipulation. Changes in heart rate variability will be recorded and measured pre and post intervention i.e. before and after manipulation. This is a one time study and changes will be assessed accordingly.)
|
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
1. Age group between 18-30.
2. Healthy individuals with no medical history or present medical condition. |
|
| ExclusionCriteria |
| Details |
1. Patient with history of recent trauma around neck, shoulder or spinal region along with fracture of vertebrae.
2. Those who have problem with visual, auditory or cardio-respiratory dysfunctions.
3. People with drug or alcohol abuse records. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Heart Rate Variability on C2 Manipulation. |
Outcome data will be collected at baseline and just after intervention. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="25"
Sample Size from India="25"
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
|
Phase 1 |
|
Date of First Enrollment (India)
|
28/03/2024 |
| 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="0"
Months="0"
Days="28" |
|
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
|
It is an interventional, single arm study with healthy participants within the age group of 18-30 years. The participants will be informed about the study and written informed consent will be taken. First, each participant’s demographic details including age, height, weight and blood pressure will be collected as a baseline data. Heart rate variability is the inter beat variability in heart rate and is moderated by the balance of sympathetic and parasympathetic divisions of autonomic nervous system. It reflects regulation of autonomic balance, blood pressure, gas exchange, heart and vascular tone. Electrocardiography can be used to obtain low frequency to high frequency ratios representing ANS response. Heart rate variability is assessed of the healthy participants with the ECG before and just after the intervention which is axis(C2) manipulation. The heart rate variability is measured by the ECG(Electrocardiography). |