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ISRCTN
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ISRCTN71100165
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ClinicalTrials.gov identifier
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Public title
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A pilot randomised controlled trial of yoga for chronic low back pain
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Scientific title
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Acronym
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Yoga Pilot
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Serial number at source
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15/08/06 Version 3
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Study hypothesis
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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.
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Ethics approval
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MREC approval was granted in October 2006. Research Governance approval was given on 9th March 2007.
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Study design
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Pragmatic single site randomised controlled trial with equal allocation
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Chronic low back pain
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Participants - inclusion criteria
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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
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Participants - exclusion criteria
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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
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Anticipated start date
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21/05/2007
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Anticipated end date
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18/09/2007
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Status of trial
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Completed
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Patient information material
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Target number of participants
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20
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Interventions
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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.
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Primary outcome measure(s)
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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.
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Secondary outcome measure(s)
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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.
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Sources of funding
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York Trials Unit (UK) - Department of Health Sciences, University of York
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Trial website
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http://www.york.ac.uk/healthsciences/centres/trials/
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Publications
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Contact name
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Prof
David
Torgerson
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Address
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Department of Health Sciences
Seebohm Rowntree Building (Area 4)
University of York
Heslington
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City/town
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York
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Zip/Postcode
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YO10 5DD
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Country
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United Kingdom
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Email
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djt6@york.ac.uk
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Sponsor
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University of York (UK)
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Address
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c/o Ms Sue Final
Intellectual Property manager
Research Support Office
Heslington
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City/town
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York
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Zip/Postcode
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YO10 5DD
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Country
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United Kingdom
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Email
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hc18@york.ac.uk
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Sponsor website:
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http://www.york.ac.uk/
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Date applied
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11/06/2007
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Last edited
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02/08/2007
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Date ISRCTN assigned
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02/08/2007
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