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CTRI Number  CTRI/2018/09/015851 [Registered on: 26/09/2018] Trial Registered Prospectively
Last Modified On: 26/02/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Yoga & Naturopathy 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   To study the effectiveness of yoga in back pain. 
Scientific Title of Study   To study the effectiveness of Yoga Postures in the management of Chronic Non Specific Low Back Pain.  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Vandana Phadke 
Designation  Scientist D 
Affiliation  Indian Spinal Injuries Centre 
Address  Indian Spinal Injuries Centre, Vasant Kunj, New Delhi

South West
DELHI
110070
India 
Phone  9560932089  
Fax  011-26898810  
Email  biomechanics.research@isiconline.org  
 
Details of Contact Person
Scientific Query  
Name  Vandana Phadke 
Designation  Scientist D 
Affiliation  Indian Spinal Injuries Centre 
Address  Indian Spinal Injuries Centre, Vasant Kunj, New Delhi

South West
DELHI
110070
India 
Phone  9560932089  
Fax  011-26898810  
Email  biomechanics.research@isiconline.org  
 
Details of Contact Person
Public Query  
Name  Vandana Phadke 
Designation  Scientist D 
Affiliation  Indian Spinal Injuries Centre 
Address  Indian Spinal Injuries Centre, Vasant Kunj, New Delhi

South West
DELHI
110070
India 
Phone  9560932089  
Fax  011-26898810  
Email  biomechanics.research@isiconline.org  
 
Source of Monetary or Material Support  
DST Satyam Department of Science & Technology, Technology Bhavan, New Mehrauli Road,, New Delhi-110016. 
 
Primary Sponsor  
Name  Indian Spinal Injuries Center 
Address  Sector C, Vasant Kunj New Delhi-110016. 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Vandana Phadke  Indian Spinal Injuries Centre  Resarch Department, First Floor, ISIC ,Sector C, Vasant Kunj, Pin-110070
South West
DELHI 		 011-42255230
011-26898810
biomechanics.research@isiconline.org 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
indian spinal injuries center  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M545||Low back pain,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Conventional Treatment  Ergonomic Advice Lifestyle Modifications Regular Exercises(Walking) 
Intervention  Partially supervised yoga therapy  Yoga Asana, Pranayam and Meditation 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  -Subjects with low back pain with history of symptoms > 3 months
-Average back pain intensity ≥3 for the previous seven days on a 0–10 numerical rating scale  
 
ExclusionCriteria 
Details  Subjects
-diagnosed with potential causes of Low back pain((underlying systemic or visceral disease, malignancy, pregnancy, spondylolisthesis, spinal stenosis, scoliosis, recent vertebral fracture);
-with evidence of severe or progressive neurologic deficits
-with previous back surgery
-using yoga for their back pain
-planning to seek other treatment for back pain
-who are contraindicated for yoga or exercise
-with unstable medical or severe psychiatric conditions
-with back related compensation or litigation
- or unable to complete the study protocol
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Pain using Numerical Pain Rating score
Disability using Oswestry Disability Index
Lumbo Pelvic rhythm
Core muscle function by latency of core muscles tested by EMG
Morphology of multifidus by cross sectional area using MRI
Adverse Event 		 0 week and end of 12 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Adverse Event  Every Week(For 12 weeks) 
 
Target Sample Size   Total Sample Size="96"
Sample Size from India="96" 
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)   01/10/2018 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary
Modification(s)  

Low back pain (LBP) is one of the most common causes of pain and disability. Almost 85% people suffer from LBP at least once in their lives and many suffer chronic and recurrent episodes1. Most of the patients undergo conservative management including pain medications, physiotherapy, complimentary and allied medicine techniques, ergonomic changes and lifestyle modification2. Many of these techniques, including yoga, alleviate pain and improve functional disability scores in patients3,4. It is postulated that practice of yoga brings about physical and biopyschosocial changes to achieve positive outcomes5.

Chronic LBP is associated with changes in posture, weakness of muscles, tightness of soft tissue structures around the spine and lumbopelvic complex, reduced stability and proprioception6. These largely result in pain, movement impairments and functional disability. LBP is usually also associated with other problems such as fear avoidance, sleep disturbances, anxiety or depression7,8. Though categorized as a single diagnosis, the condition is more like an umbrella term to describe a range of dysfunctions and impairments. Improvements in patient outcomes in the management of chronic LBP have been suggested with sub-categorization of patients and tailor made exercise prescriptions9,10. Past studies that have evaluated the effectiveness of yoga for management of LBP have used varied yoga techniques and generic yoga postures for all subjects irrespective of underlying pathomechanics. No studies till date have explored the effects of yoga postures on posture, rhythm and symmetry of lumbopelvic movement and associated muscle activity.

The current project shall study the effects of yoga postures on lumbopelvic kinematics and muscle activity in subjects with and without back pain. This assessment will provide information beyond the effects of yoga intervention on pain and functional disability and a possible reasoning for the same.


 c. Relevant references

1.        Balagué, F., Mannion, A. F., Pellisé, F. & Cedraschi, C. Non-specific low back pain. Lancet 379, 482–491 (2012).

2.        van Tulder, M. W., Koes, B. W. & Bouter, L. M. Conservative treatment of acute and chronic nonspecific low back pain. A systematic review of randomized controlled trials of the most common interventions. Spine (Phila. Pa. 1976). 22, 2128–56 (1997).

3.        Cramer, H., Lauche, R., Haller, H. & Dobos, G. A Systematic Review and Meta-analysis of Yoga for Low Back Pain. Clin J Pain 29, 450–460 (2013).

4.        Holtzman, S. & Beggs, R. T. Yoga for chronic low back pain: Analysis of randomized controlled trials. Pain Res. Manag. 18, 267–272 (2013).

5.        Sherman, K. J. et al. Comparison of yoga versus stretching for chronic low back pain: protocol for the Yoga Exercise Self-care (YES) trial. Trials 11, 36 (2010).

6.        Laird, R. A., Gilbert, J., Kent, P. & Keating, J. L. Comparing lumbo-pelvic kinematics in people with and without back pain: a systematic review and meta-analysis. BMC Musculoskelet. Disord. 15, 229 (2014).

7.        Andersson, G. B. Epidemiological features of chronic low-back pain. Lancet 354, 581–585 (1999).

8.        Stubbs, B. et al. The epidemiology of back pain and its relationship with depression, psychosis, anxiety, sleep disturbances, and stress sensitivity: Data from 43 low- and middle-income countries. Gen. Hosp. Psychiatry 43, 63–70 (2016).

9.        Brennan, G. P. et al. Identifying subgroups of patients with acute/subacute "nonspecific" low back pain: results of a randomized clinical trial. Spine (Phila. Pa. 1976). 31, 623–31 (2006).

10.      Karayannis, N. V, Jull, G. a & Hodges, P. W. Physiotherapy movement based classification approaches to low back pain: comparison of subgroups through review and developer/expert survey. BMC Musculoskelet. Disord. 13, 24 (2012).

 
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