A pilot randomised controlled trial of yoga for chronic low back pain
| ISRCTN | ISRCTN71100165 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN71100165 |
| Secondary identifying numbers | 15/08/06 Version 3 |
- Submission date
- 11/06/2007
- Registration date
- 02/08/2007
- Last edited
- 05/05/2011
- 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
Department of Health Sciences
Seebohm Rowntree Building (Area 4)
University of York
Heslington
York
YO10 5DD
United Kingdom
| djt6@york.ac.uk |
Study information
| Study design | Pragmatic single site randomised controlled trial with equal allocation |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | |
| Study acronym | Yoga Pilot |
| Study objectives | To assess recruitment, practicality and feasibility of a randomised controlled trial of yoga for chronic low back pain in order to inform a larger multicentre trial. |
| Ethics approval(s) | MREC approval was granted in October 2006. Research Governance approval was given on 09/032007 |
| Health condition(s) or problem(s) studied | Chronic low back pain |
| Intervention | As well as receiving their usual care patients receiving this treatment will be offered 12 weekly sessions of yoga plus the Back Book (a small information booklet aimed at patients with back pain and is based on current evidence). Each session will last 75 minutes with a Hatha and Iyenga yoga programme of relaxing, toning, stretching and breathing. The yoga package of care has been developed by several yoga specialists with the aid of GPs and physiotherapists to provide an optimal regime. |
| Intervention type | Other |
| Primary outcome measure | Back pain, measured using the Roland and Morris Back pain Questionnaire (RDQ) and the Aberdeen Back Pain Scale. Primary and secondary outcomes will be measured at baseline, 3 months, 6 months and 12 months. |
| Secondary outcome measures | 1. Quality of life, measured using the 36-item Short Form health survey (SF-36) 2. Pain self-efficacy, measured using the Pain Self-Efficacy Questionnaire (PSEQ) 3. Practicality and feasibility Primary and secondary outcomes will be measured at baseline, 3 months, 6 months and 12 months. |
| Overall study start date | 21/05/2007 |
| Completion date | 18/09/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Not Specified |
| Target number of participants | 20 |
| Key inclusion criteria | 1. Aged 18 to 65 years 2. Attended General Practice (GP) for a consultation of back pain in previous 18 months 3. Scoring four or more on the Roland and Morris back pain scale |
| Key exclusion criteria | 1. Pregnant women 2. Life-threatening co-morbidities 3. Severe documented psychiatric problems (other than mild to moderate unipolar depression or a simple anxiety state) or alcohol dependency 4. Have participated in yoga in the previous six months 5. Are currently involved or have recently been in another trial for their back pain 6. Previous spinal surgery 7. Clinical indications of serious spinal or neurological pathology |
| Date of first enrolment | 21/05/2007 |
| Date of final enrolment | 18/09/2007 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
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
Intellectual Property manager
Research Support Office
Heslington
York
YO10 5DD
England
United Kingdom
| hc18@york.ac.uk | |
| Website | http://www.york.ac.uk/ |
"ROR" |
https://ror.org/04m01e293 |
Funders
Funder type
University/education
York Trials Unit (UK) - Department of Health Sciences, University of York
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 | 01/11/2010 | Yes | No |
