| Source of record | UK Clinical Trials Gateway |
| ISRCTN | ISRCTN71100165 |
| Date ISRCTN assigned | 02/08/2007 |
| Local reference number(s) | 15/08/06 Version 3 |
| Public title | A pilot randomised controlled trial of yoga for chronic low back pain |
| Scientific title |
|
| Acronym | Yoga Pilot |
| Disease/condition/study domain | Chronic low back pain |
| Study hypothesis | 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. |
| Design/methodology | Pragmatic single site randomised controlled trial with equal allocation |
| Research ethics review | MREC approval was granted in October 2006. Research Governance approval was given on 9th March 2007. |
| Countries of trial | United Kingdom |
| Participants - 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 |
| Participants - 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 |
| Patient information material |
|
| Anticipated start date | 21/05/2007 |
| Anticipated end date | 18/09/2007 |
| Status of trial | Completed |
| Target number of participants | 20 |
| Interventions | 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. |
| Primary outcome measure(s) | 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 measure(s) | 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. |
| Trial website | http://www.york.ac.uk/healthsciences/centres/trials/ |
| Sources of funding | York Trials Unit (UK) - Department of Health Sciences, University of York |
| Sponsor name | University of York (UK) |
| Sponsor details | c/o Ms Sue Final
Intellectual Property manager
Research Support Office
Heslington
York
United Kingdom
YO10 5DD |
| Sponsor email | hc18@york.ac.uk |
| Sponsor website | http://www.york.ac.uk/ |
| Contact name | Prof David Torgerson |
| Contact details | Department of Health Sciences
Seebohm Rowntree Building (Area 4)
University of York
Heslington
York
United Kingdom
YO10 5DD |
| Contact email | djt6@york.ac.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN71100165 |
| Date last extracted from ISRCTN register | 17/04/2008 |
