| CTRI Number |
CTRI/2021/09/036838 [Registered on: 24/09/2021] Trial Registered Prospectively |
| Last Modified On: |
22/03/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Immediate effect of Electrical Modality and Relaxation Technique on Abnormal Breathing and Altered Heart Rate in the individuals with prolonged neck pain |
|
Scientific Title of Study
|
Immediate effect of Transcutaneous Electrical Nerve Stimulation (TENS) along with Relaxation Technique on Dysfunctional Breathing and Heart Rate Variability in the individuals with Chronic Neck Pain |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Gopiyani Ishani Ashwinbhai |
| Designation |
Post Graduation Student |
| Affiliation |
Dr. D.Y. Patil College of Physiotherapy, Pimpri Pune |
| Address |
Dr. D.Y. Patil College of physiotherapy, Sant Tukaram Nagar, Pimpri Pune
Dr. D.Y. Patil College of Physiotherapy, Sant Tukaram Nagar, Pimpri Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
8140008244 |
| Fax |
|
| Email |
ishanigopiyani3003@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mayura P Deshmukh |
| Designation |
Assistant Professor |
| Affiliation |
Dr. D.Y. Patil College of Physiotherapy, Pimpri Pune |
| Address |
Dr. D.Y. Patil College of physiotherapy, Sant Tukaram Nagar, Pimpri Pune
Dr. D.Y. Patil College of Physiotherapy, Sant Tukaram Nagar, Pimpri Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
8149376929 |
| Fax |
|
| Email |
mayuradeshmukh04@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Gopiyani Ishani Ashwinbhai |
| Designation |
Post Graduation Student |
| Affiliation |
Dr. D.Y. Patil College of Physiotherapy, Pimpri Pune |
| Address |
Dr. D.Y. Patil College of physiotherapy, Sant Tukaram Nagar, Pimpri Pune
Dr. D.Y. Patil College of Physiotherapy, Sant Tukaram Nagar, Pimpri Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
8140008244 |
| Fax |
|
| Email |
ishanigopiyani3003@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr. D. Y. Patil College of Physiotherapy, Pimpri Pune |
|
|
Primary Sponsor
|
| Name |
Gopiyani Ishani Ashwinbhai |
| Address |
Dr. D.Y. Patil College of Physiotherapy, Sant Tukaram Nagar, Pimpri Pune |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Gopiyani Ishani Ashwinbhai |
Dr. D.Y. Patil College of Physiotherapy, Pimpri Pune |
Dr. D.Y. Patil College of Physiotherapy, Sant Tukaram Nagar, Pimpri Pune
Pune
MAHARASHTRA |
8140008244
ishanigopiyani3003@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee DPU |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Chronic Neck Pain |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not Applicaple |
Not Applicable |
| Intervention |
Transcutaneous Electrical Nerve Stimulation (TENS) and Jacobsons Progressive Relaxation Technique |
LOW TENS will be given with 300mA intensity, Frequency of 1-5 Hz, Pulse width of 100-500 micro seconds, duration of 25 to 30 minutes. Being done with TENS, Jacobsons Relaxation Technique will be given to an individual. Jacobson relaxation technique involves flexing specific muscles, holding that position and then relaxing the muscles. This technique often involves progressing through the muscle groups of the body one at a time, beginning with the feet, spending approximately one minute on each area. as it is one time study total duration will b e 45 minutes |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
29.00 Year(s) |
| Gender |
Both |
| Details |
Individuals with chronic neck pain, Neck Disability index scores of minimum 5 or 10% points, Individuals with Normal BMI (Body Mass Index), Age group of 18 to 29 years, Both the genders (male, female) |
|
| ExclusionCriteria |
| Details |
Individuals with psychological conditions, Any neurological condition involved, Excessive physical exertion, anxious Individuals, Night shift workers, Use of medications known to affect ANS function or pain perception (Antidepressants, Benzodiazepines, Anti-inflammatory, Betablockers), Individuals with Rheumatological/Metabolic/Endocrine diseases, Skin disease individuals, Cardiopulmonary diseases, Cervical hernia/trauma/radiculopathy, Degenerative disease of spine, Recent head/face/cervical spine/thoracic surgery, Any known addiction (such as Smoking/Alcohol) |
|
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Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Heart Rate Variability (HRV),
Breathing Screen (BS) tool,
Visual Analogue Scale (VAS) |
Pre - Post Intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Not Applicable |
Not Applicable |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/10/2021 |
| Date of Study Completion (India) |
21/03/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
manuscript writing in progress |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Chronic neck pain is the commonest musculoskeletal condition amongst the healthy active population. In any Pain, Autonomic Nervous System (ANS) is modulated with the up gradation of sympathetic component which leads to increase in allostatic load resulting in Dysfunctional Breathing. Heart Rate Variability is a biomarker which reflects the function of ANS significantly. Assessment of the HRV is a non-invasive technique and can be approach to assess pain in any musculoskeletal conditions. as the pain and HRV are related to ANS dysfunction, and there is a connection between ANS and Dysfunctional Breathing, the need of the study occurs to know that if we treat neck pain with LOW TENS along with Jacobson’s Technique, is there any effect on Heart Rate Variability and Dysfunctional in Chronic Neck Pain individuals. |