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CTRI Number  CTRI/2012/11/003094 [Registered on: 08/11/2012] Trial Registered Retrospectively
Last Modified On: 25/10/2012
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Yoga]  
Study Design  Other 
Public Title of Study   YOGA THERAPY FOR LOWER BACK PAIN: A RANDOMIZED CONTROLLED TRIAL 
Scientific Title of Study   YOGA THERAPY FOR LOW BACK PAIN: DIFFERENT RESPONSES OF DISC EXTRUSIONS AND BULGES 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
46/2011/pyp-prf  Other 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Shirley Telles 
Designation  Director of Research 
Affiliation  Patanjali Research Foundation 
Address  Patanjali Yogpeeth, Phase-1

Hardwar
UTTARANCHAL
249405
India 
Phone  9897963254  
Fax    
Email  pyp.research@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Shirley Telles 
Designation  Director of Research 
Affiliation  Patanjali Research Foundation 
Address  Patanjali Yogpeeth, Phase-1

Hardwar
UTTARANCHAL
249405
India 
Phone  9897963254  
Fax    
Email  pyp.research@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Shirley Telles 
Designation  Director of Research 
Affiliation  Patanjali Research Foundation 
Address  Patanjali Yogpeeth, Phase-1

Hardwar
UTTARANCHAL
249405
India 
Phone  9897963254  
Fax    
Email  pyp.research@gmail.com  
 
Source of Monetary or Material Support  
Patanjali Research Foundation, Hardwar 
 
Primary Sponsor  
Name  Patanjali Research Foundation  
Address  Patanjali Research Foundation, Hardwar-249405, Uttarakhand 
Type of Sponsor  Other [Private Research Organization] 
 
Details of Secondary Sponsor  
Name  Address 
Patanjali Yogpeeth  Haridwar- 249405, Uttarakhand 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Shirley Telles  Patanjali Yogpeeth  Dept. of Yoga Research,Patanjali Yogpeeth, Haridwar-249405, Uttarakhand, India
Hardwar
UTTARANCHAL 
9897963254

pyp.research@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Patanjali Research Foundation Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Patients having lower back pain were recruited,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Control Group  some educational classes were provided 3 times in a week for 3 months 
Intervention  Yoga Group  Participants of the yoga group practiced loosening exercises, asanas, pranayamas and relaxation techniques for 3 months, 3 times in a week  
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  1. Age 20-45 years
2. Rolland Morris Questionnaire score >3 and/or acute sciatica in past three months
3. Presence of at least one disc herniation or bulge 
 
ExclusionCriteria 
Details  1. Previous spinal surgery
2. Central canal stenosis
3. Severe osteoporosis
4. Pregnancy
5. Other disorders preventing active participation in therapy programme 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
1. Health status measurement for low back pain (using Rolland Morris Disability recorded at questionnaire - RMDQ), 2. Physical examination of leg and back and 3. Magnetic resonance imaging (MRI) for lumbosacral spine (using Philips Magnetic Resonance Achieva 1.5T A-Series),   Beginning and end of 3 months 
 
Secondary Outcome  
Outcome  TimePoints 
1. Heart rate variability (HRV) and abdominal respiration (using a two channel EKG and respiration recording system; MP45 Biopac Student Lab, BIOPAC System Inc, U.S.A.), 2. Spinal flexibility (using Sit and Reach flexibility tester, model 01285A, Lafayette Instrument), 3. Level of state anxiety (using Spielbergers State Trait Anxiety - STAI) and 4. Level of back pain and mental stress (using analog scales)   Before and after 3 months 
 
Target Sample Size   Total Sample Size="126"
Sample Size from India="126" 
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" 
Phase of Trial   N/A 
Date of First Enrollment (India)   07/05/2011 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Not published 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

One hundred and twenty six participants of both sexes having lower back pain with ages between 20 and 45 years were randomly assigned to yoga and control groups using a computer generated random number table. In the yoga group, there were sixty three participants (32 males and 31 females) of both sexes (group mean ± S.D., 37.03 ± 6.76 years) and in the control group also; there were sixty three participants (33 males and 30 females) of both sexes (group mean ± S.D., 36.40 ± 6.54 years). Participants of both groups were staying close to a residential yoga center located in north India. All of them had lower back pain. Their participation in this study was voluntary. Prior to the study, signed informed consent of all participants was taken separately. The study protocol was approved by the Institutional Ethics Committee (IEC). Health status measurement for low back pain (using Rolland Morris Disability questionnaire - RMDQ), physical examination of leg and back, magnetic resonance imaging (MRI) for lumbosacral spine (using Philips Magnetic Resonance Achieva 1.5T A-Series), heart rate variability (HRV) and abdominal respiration (using a two channel EKG and respiration recording system; MP45 Biopac Student Lab, BIOPAC System Inc, U.S.A.), spinal flexibility (using Sit and Reach flexibility tester, model 01285A, Lafayette Instrument), the level of state anxiety (using Spielbergers State Trait Anxiety - STAI) and the level of back pain and mental stress (using analog scales) were measured. Assessments were done before and after three months of intervention. It was a randomized controlled study. Participants of the yoga group practiced loosening exercises, asanas, pranayamas and relaxation techniques in the morning (08:00 - 09:00 hours) thrice in a week for three months conducted by an experienced yoga teacher who had no other part in the trial. For the rest of the week, they were practicing yoga at home. Some educational classes were provided to the participants of the control group. Repeated measures analysis of variance (ANOVA) will be used to compare data recorded before and after three months with pre data, using PASW Version 18.0. There will be two Within subjects factors [Groups (Yoga, Control) and States (Pre, Post)].

 

 
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