| 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
|
|
|
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)]. |