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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  
Name  Address 
NA  NA 
 
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  
Status 
Not Applicable 
 
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.

 

 

 
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