Pragmatic randomised controlled trial of yoga for the treatment of chronic low back pain
| ISRCTN | ISRCTN81079604 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN81079604 |
| Secondary identifying numbers | 17727 |
- Submission date
- 02/02/2007
- Registration date
- 30/03/2007
- Last edited
- 18/02/2014
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof David Torgerson
Scientific
Scientific
York Trials Unit, Department of Health Sciences
Area 4, Seebohm Rowntree Building
University of York, Heslington
York
YO10 5DD
United Kingdom
| Phone | +44 (0)1904 321340 |
|---|---|
| djt6@york.ac.uk |
Study information
| Study design | Pragmatic randomised controlled trial. |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | |
| Study acronym | Yoga Trial |
| Study objectives | To assess the effectiveness of yoga therapy on the quality of life and pain of patients with chronic low back pain. Aims and purpose of the proposed research: 1. To produce a package of yoga care agreed by a cross-section of yoga practitioners 2. To undertake a trial of the agreed yoga care package on patients with low back pain (LBP) 3. To undertake a cost effectiveness analysis of yoga treatment for LBP 4. To produce a manual for yoga teachers for the treatment of LBP |
| Ethics approval(s) | Ethics approval received from the Leeds East Research Ethics Committee on the 20th June 2007 (ref: 07/Q1206/35). |
| Health condition(s) or problem(s) studied | Chronic low back pain |
| Intervention | We will compare the yoga regime with standard care. The yoga intervention will be 12 weekly 75 minute classes. There are a number of recommended yoga practices for people with low back pain, which are delivered by practitioners of different yoga traditions. Among the applicants are representatives of the two most popular styles of yoga within the UK: Integral yoga (sometimes known as Hatha) and Iyengar yoga. Within the first three months of the study, whilst we get ethics permission and NHS Research and Development approval, we will conduct a series of meetings between experienced practitioners of yoga in order to agree on a basic package of yoga that can be delivered by yoga practitioners of these two styles. Yoga therapists taking part in the study will be trained in this package as well as low back pain assessment procedures. This will take place at the Yoga Biomedical Trust, London. As part of the study we will develop a manual for yoga practitioners and their patients. The manual will describe an agreed series of yoga techniques that can be readily used by any experienced yoga teacher and can be practised at home by patients receiving yoga. The patients allocated to the control group will receive any ongoing treatment they would normally receive. Intervention patients will also receive in addition their normal treatments if these are deemed necessary. Both groups will receive the Back Book which is an evidence based booklet written by a group of international back pain experts and is aimed at patients who have chronic low back pain. |
| Intervention type | Other |
| Primary outcome measure | Roland and Morris back pain questionnaire. |
| Secondary outcome measures | 1. Quality of life as assessed by 12-item Short Form health survey (SF12) 2. Aberdeen Back Pain Scale 3. EuroQol 4. Costs |
| Overall study start date | 01/04/2007 |
| Completion date | 31/03/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 262 |
| Key inclusion criteria | The target population will be aged between 18 - 65 presenting with low back pain, which is defined as pain of a musculoskeletal origin bounded by the lowest ribs and gluteal folds. Patients with referred pain will be included as long as it does not go below the knee. |
| Key exclusion criteria | 1. Patients over 65 as they are more likely to have serious spinal pathology 2. Clinical indications of serious spinal or neurological pathology 3. Previous spinal surgery 4. History of psychosis or alcohol abuse (due to difficulty in assessing outcomes) |
| Date of first enrolment | 01/04/2007 |
| Date of final enrolment | 31/03/2010 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
York Trials Unit, Department of Health Sciences
York
YO10 5DD
United Kingdom
YO10 5DD
United Kingdom
Sponsor information
University of York (UK)
University/education
University/education
c/o Ms Sue Final
University of York
Research Office
Heslington
York
YO10 5DD
England
United Kingdom
| Phone | +44 (0)1904 434401 |
|---|---|
| smf3@york.ac.uk | |
"ROR" |
https://ror.org/04m01e293 |
Funders
Funder type
Charity
Arthritis Research Campaign (ARC) (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 01/05/2010 | Yes | No | |
| Results article | results | 01/11/2011 | Yes | No | |
| Other publications | economic evaluation | 15/08/2012 | Yes | No | |
| Results article | results | 01/09/2014 | Yes | No |
