Condition category
Musculoskeletal Diseases
Date applied
11/06/2007
Date assigned
02/08/2007
Last edited
05/05/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.york.ac.uk/healthsciences/centres/trials/

Contact information

Type

Scientific

Primary contact

Prof David Torgerson

ORCID ID

Contact details

Department of Health Sciences
Seebohm Rowntree Building (Area 4)
University of York
Heslington
York
YO10 5DD
United Kingdom
djt6@york.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

15/08/06 Version 3

Study information

Scientific title

Acronym

Yoga Pilot

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.

Ethics approval

MREC approval was granted in October 2006. Research Governance approval was given on 09/032007

Study design

Pragmatic single site randomised controlled trial with equal allocation

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

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

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

21/05/2007

Overall trial end date

18/09/2007

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

20

Participant 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

Recruitment start date

21/05/2007

Recruitment end date

18/09/2007

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of Health Sciences
York
YO10 5DD
United Kingdom

Sponsor information

Organisation

University of York (UK)

Sponsor details

c/o Ms Sue Final
Intellectual Property manager
Research Support Office
Heslington
York
YO10 5DD
United Kingdom
hc18@york.ac.uk

Sponsor type

University/education

Website

http://www.york.ac.uk/

Funders

Funder type

University/education

Funder name

York Trials Unit (UK) - Department of Health Sciences, University of York

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. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20920800

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

    Cox H, Tilbrook H, Aplin J, Semlyen A, Torgerson D, Trewhela A, Watt I, A randomised controlled trial of yoga for the treatment of chronic low back pain: results of a pilot study., Complement Ther Clin Pract, 2010, 16, 4, 187-193, doi: 10.1016/j.ctcp.2010.05.007.

Additional files

Editorial Notes