Condition category
Musculoskeletal Diseases
Date applied
02/02/2007
Date assigned
30/03/2007
Last edited
18/02/2014
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Additional files

Editorial Notes