| CTRI Number |
CTRI/2021/08/035984 [Registered on: 26/08/2021] Trial Registered Prospectively |
| Last Modified On: |
29/03/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Physiotherapy (Including Yoga) ] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of Yoga And Dynamic Neuromuscular Stabilization Exercise In Chronic Low Back Pain |
|
Scientific Title of Study
|
Comparison of Yoga and Dynamic Neuromuscular Stabilization Exercise in Chronic Low Back Pain on Magnetic Resonance Imaging of Lumbar Multifidus- A Randomised Controlled Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr V Prem |
| Designation |
Head of Department and Associate Professor (Senior Scale) |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Department of Physiotherapy
Manipal College of Health Professionals Bangalore Campus Manipal Academy of Higher Education
Bangalore KARNATAKA 560017 India |
| Phone |
9886647732 |
| Fax |
|
| Email |
prem.v@manipal.edu |
|
Details of Contact Person Scientific Query
|
| Name |
Dr V Prem |
| Designation |
Head of Department and Associate Professor (Senior Scale) |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Department of Physiotherapy
Manipal College of Health Professionals Bangalore Campus Manipal Academy of Higher Education
Bangalore KARNATAKA 560017 India |
| Phone |
9886647732 |
| Fax |
|
| Email |
prem.v@manipal.edu |
|
Details of Contact Person Public Query
|
| Name |
Mr K Soundararajan |
| Designation |
Junior Research Fellow cum PhD Scholar |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Department of Physiotherapy
Manipal College of Health Professionals Bangalore Campus Manipal Academy of Higher Education
Bangalore KARNATAKA 560017 India |
| Phone |
9551163416 |
| Fax |
|
| Email |
k.soundararajan1995@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government of India, Ministry of Science and Technology, Department of Science and Technology, Funding under the Science and Technology of Yoga and Meditation (SATYAM) of DST |
|
|
Primary Sponsor
|
| Name |
Government of India Ministry of Science and Technology Department of Science and Technology |
| Address |
Government of India, Ministry of Science and Technology, Department of Science and Technology, Technology Bhavan, New Mehrauli Road, New Delhi-110 016 |
| Type of Sponsor |
Government funding agency |
|
|
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 |
| Mr K Soundararajan |
Manipal Hospital, Bengaluru |
Department of Physiotherapy,
Out Patient Service - Physical Medicine and Rehabilitation,
Manipal Hospital, Bengaluru 560017, Karnataka Bangalore KARNATAKA |
9551163416
k.soundararajan1995@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee of Manipal Hospitals, Bangalore |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M625||Muscle wasting and atrophy, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Dynamic Neuromuscular Stabilization (DNS) |
Dynamic neuromuscular stabilization will receive developmental postures based on developmental kinesiology. It will involve supine 3month position, side lying position, Quadruped, oblique sitting, bear position, squat position. Each position will be performed for 3-5 days/week for 12 weeks |
| Intervention |
Yoga |
Yoga group will receive structured yoga session targeting multifidus muscle. It will involve pavanmukthasana, shashankasana breathing, ardhakati chakrasana, Uttita Parsvakonasana, parivritta trikosana, Vakrasana, Pranayama involving Vibhagya pranayama, Nadi shuddi, Bhramari, Shavasana for 3-5 days/week for 12 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Subjects diagnosed with chronic low back pain (duration more than 12 weeks) |
|
| ExclusionCriteria |
| Details |
1. Inflammatory pathology of the lumbar spine
2. Lumbar radiculopathy
3. Subjects who have recent spinal fracture or surgery
4. Have lumbar pain of traumatic origin
5. If they are current or past smokers or tobacco chewers
6. Have participated in a yoga or lumbar exercise program in the past 3 months
7. Pain Score VAS more than 4
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Magnetic resonance imaging (MRI) |
At baseline (0 week) and at end of 12th week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Ultrasound Imaging (RUSI) |
At baseline (0 week) and at end of 12th week |
| Visual analogue scale (VAS) |
At baseline (0 week) and at end of 12th week |
| Oswestry Disability Index (ODI) |
At baseline (0 week) and at end of 12th week |
| The Life Orientation Test (LOT) |
At baseline (0 week) and at end of 12th week |
| Patient-Reported Outcomes Measurement Information System–Physical Function- short-form (PROMIS-PF) |
At baseline (0 week) and at end of 12th week |
| Pain Catastrophizing Scale (PCS) |
At baseline (0 week) and at end of 12th week |
| Tampa Scale for Kinesiophobia (TSK) |
At baseline (0 week) and at end of 12th week |
| Positive and Negative Affect Schedule (PANAS) |
At baseline (0 week) and at end of 12th week |
| Coping Strategies Questionnaire (CSQ) |
At baseline (0 week) and at end of 12th week |
| Pain Self-Efficacy Questionnaire (PSEQ) |
At baseline (0 week) and at end of 12th week |
|
|
Target Sample Size
|
Total Sample Size="144" Sample Size from India="144"
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)
|
01/09/2021 |
| 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="3" Months="0" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
NA |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The lifetime prevalence of low back pain is reported to be as high as 84%, and the prevalence of chronic low back pain is about 23%, with 11–12% of the population being disabled by low back pain. Yoga is a traditional mind-body system originating in India over 4000 years ago. The goal of yoga, a Sanskrit term meaning “yoke or union†do not centre primality on physical, but rather on integration of mind, body and spirit, cultivation of balance, calm, harmony and awareness. Cochrane review on yoga for chronic low back pain has concluded, it is uncertain whether there is any difference between yoga and other exercise for back-related function or pain. Recent study has validated integrated yoga module comprising yoga postures and breathing for chronic low back pain, however scientific evidence of effect of yoga on pathology of low back pain is lacking. Lumbar muscle degeneration is characterized by a decrease in cross-sectional area (CSA) and an increase in the amount of fat content of the lumbar paraspinal muscles. According to the recent studies, the patients with chronic low back pain have Thoraco lumbar Fascia (TLF) thickened by 25% or more measured through Ultrasound imaging. No study could be retrieved on the effects of yoga on cross sectional area of lumbar multifidus with magnetic resonance imaging and thoracolumbar fascia using Ultrasound imaging in chronic low back pain. Patients diagnosed with chronic low back pain will be allocated randomly in two groups: yoga and dynamic muscular stabilisation group. Both the groups will undergo training under supervision for 3-5 days/week for 12 weeks. Baseline data will be collected followed by recording of primary outcome measures (Magnetic Resonance Imaging) and secondary outcome measures (Ultrasound Imaging, Oswestry Disability index, Visual Analogue Score, Optimism, self-efficacy, mood, physical activity, fear of movement, pain catastrophizing and coping) at baseline, after 12 weeks. Data will be collected and analyzed. |