| CTRI Number |
CTRI/2025/03/082918 [Registered on: 20/03/2025] Trial Registered Prospectively |
| Last Modified On: |
17/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
EFFECT OF SHVASA KRIYA ON THE NON-SPECIFIC CHRONIC LOW BACK PAIN INDIVIDUALS |
|
Scientific Title of Study
|
IMMEDIATE EFFECT OF SHVASA KRIYA ON HEART RATE VARIABILITY AND ELECTROMYOGRAPHY IN NON-SPECIFIC CHRONIC LOW BACK PAIN PATIENTS - A QUASI EXPERIMENTAL 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 |
Dr Laishram Nungshirthoi Chanu |
| Designation |
MD (Clinical Yoga) Scholar |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College of Naturopathy and Yogic sciences |
| Address |
Department of Yoga and Therapeutics, Sri Dharmasthala
Manjunatheshwara College of Naturopathy and Yogic Sciences Ujire
Belthangady Dakshina kannada Karnataka India 574240
Dakshina Kannada KARNATAKA 574240 India |
| Phone |
9366692021 |
| Fax |
|
| Email |
laishramchanumachathoi233@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Laishram Nungshirthoi Chanu |
| Designation |
MD (Clinical Yoga) Scholar |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College of Naturopathy and Yogic sciences |
| Address |
Department of Yoga and Therapeutics, Sri Dharmasthala
Manjunatheshwara College of Naturopathy and Yogic Sciences Ujire
Belthangady Dakshina kannada Karnataka India 574240
Dakshina Kannada KARNATAKA 574240 India |
| Phone |
9366692021 |
| Fax |
|
| Email |
laishramchanumachathoi233@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Ashwin V P |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College of Naturopathy and Yogic Sciences |
| Address |
Department of Yoga and Therapeutics, Sri Dharmasthala
Manjunatheshwara College of Naturopathy and Yogic Sciences Ujire
Belthangady Dakshina kannada Karnataka India 574240
Dakshina Kannada KARNATAKA 574240 India |
| Phone |
9538372524 |
| Fax |
|
| Email |
ashwin09@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Dharmasthala Manjunatheshwara Yoga and Nature cure Hospital, shantivana, Dharmasthala, Belthangadi, Dakshina kannada, karnataka, India - 574216 |
|
|
Primary Sponsor
|
| Name |
Dr Laishram Nungshirthoi Chanu |
| Address |
SDM College of Naturopathy and Yogic Sciences, Ujire, Belthangadi, Dakshina kannada, india - 574240 |
| 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 |
| Dr Laishram Nungshirthoi Chanu |
Sri Dharmasthala Manjunatheshwara Yoga and Nature Cure Hospital, shantivana |
COE Department of Yoga and Therapeutics Shantivana, Dharmasthala, Belthangadi, Dakshina Kannada, Karnataka, India - 574216
Dakshina Kannada
KARNATAKA Dakshina Kannada KARNATAKA |
9366692021
laishramchanumachathoi233@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri Dharmasthala Manjunatheshwara College of Naturopathy and Yogic Sciences Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M545||Low back pain, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
| Intervention |
Shvasa kriya |
shvasa kriya protocol will be practiced by all the subjects for 30 minutes. it is combination of asanas and breathing exercises. it has i. Hand in and out breathing, ii. Hand stretch breathing, iii. Ankle stretch breathing, iv. Straight leg raising breathing (alternate legs), v. Setu -bandha sarvangasana, vi. . Bhujangasana (cobra pose), vii. Salabhasana, viii. Sasankasana breathing, ix. Tiger stretch breathing, x Rabbit breathing |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
History of CLBP of more than 3 months.
Both male and female patients.
Pain in the lumbar spine with or without radiating pain on the leg.
Age 30-60 years |
|
| ExclusionCriteria |
| Details |
Had performed yoga in the previous 6 months
Cannot get off the floor unaided
Has a life-threatening comorbid condition
Previously undergone spinal surgery
Had a severe documentary psychiatric problem |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Electromyography (EMG)
Heart Rate Variability |
pre, post |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="40" Sample Size from India="40"
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)
|
10/04/2025 |
| 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="0" Months="2" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Low back pain (LBP) is a significant global health issue, affecting millions and expected to rise substantially by 2050, making it the leading cause of disability worldwide. Chronic LBP is associated with alterations in the nervous system, particularly in the corticostriatal circuitry and mesolimbic brain structures, leading to increased activity in cognitive-emotional areas such as the prefrontal cortex, amygdala, and insula. It also affects heart rate variability (HRV), reflecting changes in cardiac autonomic regulation, and impacts muscle function, which can be assessed using electromyography (EMG). Yoga, specifically pranayama, has been recognized for its benefits in improving physical, psychological, and neurophysiological health. Pranayama enhances breathing patterns, increasing oxygen levels and aiding recovery. This study aims to investigate the impact of Shvasa Kriya, a breathing technique involving body movement, on patients with non-specific chronic lower back pain, hypothesizing that it will lead to improvements in heart rate, muscle function, and coordination. |