Contact information
Type
Scientific
Primary contact
Prof David Torgerson
ORCID ID
Contact details
York Trials Unit
Department of Health Sciences
Area 4
Seebohm Rowntree Building
University of York
Heslington
York
YO10 5DD
United Kingdom
+44 (0)1904 321340
djt6@york.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
17727
Study information
Scientific title
Acronym
Yoga Trial
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
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.
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
Primary outcome measures
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 trial start date
01/04/2007
Overall trial end date
31/03/2010
Reason abandoned
Eligibility
Participant 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.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
262
Participant 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)
Recruitment start date
01/04/2007
Recruitment end date
31/03/2010
Locations
Countries of recruitment
United Kingdom
Trial participating centre
York Trials Unit, Department of Health Sciences
York
YO10 5DD
United Kingdom
Sponsor information
Organisation
University of York (UK)
Sponsor details
c/o Ms Sue Final
University of York
Research Office
Heslington
York
YO10 5DD
United Kingdom
+44 (0)1904 434401
smf3@york.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
Charity
Funder name
Arthritis Research Campaign (ARC) (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
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
Publication citations
-
Protocol
Cox H, Tilbrook H, Aplin J, Chuang LH, Hewitt C, Jayakody S, Semlyen A, Soares MO, Torgerson D, Trewhela A, Watt I, Worthy G, A pragmatic multi-centred randomised controlled trial of yoga for chronic low back pain: trial protocol., Complement Ther Clin Pract, 2010, 16, 2, 76-80, doi: 10.1016/j.ctcp.2009.09.010.
-
Results
Tilbrook HE, Cox H, Hewitt CE, Kang'ombe AR, Chuang LH, Jayakody S, Aplin JD, Semlyen A, Trewhela A, Watt I, Torgerson DJ, Yoga for chronic low back pain: a randomized trial., Ann. Intern. Med., 2011, 155, 9, 569-578, doi: 10.7326/0003-4819-155-9-201111010-00003.
-
Economic evaluation
Chuang LH, Soares MO, Tilbrook H, Cox H, Hewitt CE, Aplin J, Semlyen A, Trewhela A, Watt I, Torgerson DJ, A pragmatic multicentered randomized controlled trial of yoga for chronic low back pain: economic evaluation., Spine, 2012, 37, 18, 1593-1601, doi: 10.1097/BRS.0b013e3182545937.
-
Results
Tilbrook HE, Hewitt CE, Aplin JD, Semlyen A, Trewhela A, Watt I, Torgerson DJ, Compliance effects in a randomised controlled trial of yoga for chronic low back pain: a methodological study., Physiotherapy, 2013, doi: 10.1016/j.physio.2013.10.001.