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Pragmatic randomised controlled trial of yoga for the treatment of chronic low back pain
ISRCTN ISRCTN81079604
DOI 10.1186/ISRCTN81079604
ClinicalTrials.gov identifier
EudraCT number
Public title Pragmatic randomised controlled trial of yoga for the treatment of chronic low back pain
Scientific title
Acronym Yoga Trial
Serial number at source 17727
Study hypothesis 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
Lay summary Not provided at time of registration
Ethics approval Ethics approval received from the Leeds East Research Ethics Committee on the 20th June 2007 (ref: 07/Q1206/35).
Study design Pragmatic randomised controlled trial.
Countries of recruitment United Kingdom
Disease/condition/study domain Chronic low back pain
Participants - 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.
Participants - 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)
Anticipated start date 01/04/2007
Anticipated end date 31/03/2010
Status of trial Completed
Patient information material
Target number of participants 262
Interventions 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.
Primary outcome measure(s) Roland and Morris back pain questionnaire.
Secondary outcome measure(s) 1. Quality of life as assessed by 12-item Short Form health survey (SF12)
2. Aberdeen Back Pain Scale
3. EuroQol
4. Costs
Sources of funding Arthritis Research Campaign (ARC) (UK)
Trial website
Publications 1. 2010 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/20347837
2. 2011 results in: http://www.ncbi.nlm.nih.gov/pubmed/22041945
3. 2012 economic evaluation in: http://www.ncbi.nlm.nih.gov/pubmed/22433499
4. 2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/24530169
Contact name Prof  David  Torgerson
  Address York Trials Unit, Department of Health Sciences
Area 4, Seebohm Rowntree Building
University of York, Heslington
  City/town York
  Zip/Postcode YO10 5DD
  Country United Kingdom
  Tel +44 (0)1904 321340
  Email djt6@york.ac.uk
Sponsor University of York (UK)
  Address c/o Ms Sue Final
University of York
Research Office
Heslington
  City/town York
  Zip/Postcode YO10 5DD
  Country United Kingdom
  Tel +44 (0)1904 434401
  Email smf3@york.ac.uk
Date applied 02/02/2007
Last edited 18/02/2014
Date ISRCTN assigned 30/03/2007
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