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ISRCTN
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ISRCTN33808269
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DOI
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10.1186/ISRCTN33808269
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ClinicalTrials.gov identifier
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EudraCT number
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Public title
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QUeen Elizabeth physiotherapy post lumbar discectomy STudy: a pilot and feasibility trial - QUEST
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Scientific title
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QUeen Elizabeth Physiotherapy post lumbar discectomy STudy: a feasibility and pilot phase II trial to inform the development of a future phase III randomised controlled trial (QUEST)
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Acronym
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QUEST
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Serial number at source
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1
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Study hypothesis
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One to one physiotherapy plus the Patient Leaflet will be more beneficial than the Patient Leaflet (phase II trial)
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Lay summary
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Lay summary under review 2
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Ethics approval
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West Midlands – Solihull Research Ethics Committee, 25 September 2012, ref: 12/WM/0224
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Study design
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Pilot/ feasibility study of a randomised controlled trial with two arms
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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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Rehabilitation following lumbar spinal surgery
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Participants - inclusion criteria
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1. Male and female patients aged >18 years
2. Post primary, single level, lumbar discectomy (including microdiscectomy)
3. Ability to communicate in English
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Participants - exclusion criteria
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1. Previous surgery at the same spinal level
2. Co-morbidities that might impact on ability to participate in study interventions e.g. neurological disorders, cognitive dysfunction, uncontrolled cardiovascular disease, osteoporotic fracture, spondylolythesis, MS, tumour
3. Complications from surgery e.g. excessive bleeding, severe intra-operative root damage, level error, or severe wound infection that would prevent participation in either intervention
4. Participation in a concurrent trial
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Anticipated start date
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26/10/2012
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Anticipated end date
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26/05/2014
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Status of trial
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Ongoing |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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70
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Interventions
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1. Up to 8 sessions of individualised 1-1 physiotherapy over an 8-week period; treatment in-line with pre-defined framework for decision-making; starting approximately 4 weeks post surgery AND specifically designed patient leaflet
2. Specifically designed patient leaflet
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Primary outcome measure(s)
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Roland Morris Disability Questionnaire (0 to 24)
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Secondary outcome measure(s)
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1. Global Perceived Effect scale (0 to 7)
2. VAS back pain (0 to 10cm) & VAS leg pain (0 to 10cm)
3. Straight Leg Raise (cm)
4. Time to return to work / normal function / full duty (as relevant) from date of operation
5. EQ-5D 5L
6. Tampa Scale for Kinesiophobia (fear of movement)
7. Fear avoidance and beliefs questionnaire
8. Range of lumbar movement
9. Use of medication
10. Re-operation
11. Level of compliance with exercises
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Sources of funding
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Queen Elizabeth Hospital Birmingham Charity (UK)
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Trial website
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Publications
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Contact name
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Dr
Alison
Rushton
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Address
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University of Birmingham
School of Health & Population Sciences
College of Medical and Dental Sciences
52 Pritchatts Road
Edgbaston
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City/town
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Birmingham
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Zip/Postcode
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B15 2TT
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Country
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United Kingdom
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Tel
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+44 (0)121 415 8597
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Fax
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+44 (0)121 4143158
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Email
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a.b.rushton@bham.ac.uk
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Sponsor
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University of Birmingham (UK)
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Address
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Research Governance Team
Aston Webb Building
Edgbaston
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City/town
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Birmingham
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Zip/Postcode
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B15 2TT
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Country
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United Kingdom
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Tel
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+44 (0)121 414 4418
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Email
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researchgovernance@contacts.bham.ac.uk
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Sponsor website:
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http://www.birmingham.ac.uk/researchsupportgroup
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Date applied
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09/11/2012
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Last edited
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18/12/2012
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Date ISRCTN assigned
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18/12/2012
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