Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
7086
Study information
Scientific title
Changing perceptions of work ability in people with low back pain: feasibility and economic evaluation (phase 2)
Acronym
Study hypothesis
To examine the feasibility of adding an individually targeted enhanced vocational dimension to an existing NHS rehabilitation programme for employed patients with back pain.
Ethics approval
Derbyshire Research Ethics Committee approved on the 24th March 2009 (ref: 09/H0401/15)
Study design
Randomised interventional treatment trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
GP practices
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Topic: Primary Care Research Network for England, Musculoskeletal; Subtopic: Not Assigned, Musculoskeletal (all Subtopics); Disease: Musculoskeletal, All Diseases
Intervention
Control: Group back pain rehabilitation programme
Intervention: Group rehabilitation plus individually targeted work-focused intervention - up to 8 face-to-face treatments over a 16 week period from baseline.
Intervention type
Other
Phase
Phase II
Drug names
Primary outcome measures
Perceived work ability, measured with the Work Ability Index at baseline and at 6 months post-randomisation
Secondary outcome measures
All measured at baseline and 6 months post-randomisation:
1. Roland and Morris Disability Questionnaire
Overall trial start date
08/05/2009
Overall trial end date
31/10/2009
Reason abandoned
Eligibility
Participant inclusion criteria
1. Offered treatment by Nottingham Back and Pain Team
2. Employed
3. Concerned about work ability due to low back pain
4. Aged 18 years and over, male and female
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Planned Sample Size: 50; UK Sample Size: 50
Participant exclusion criteria
1. Already receiving vocational rehabilitation via NHS for low back pain
2. Not fluent in English
Recruitment start date
08/05/2009
Recruitment end date
31/10/2009
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Division of Rehabilitation and Ageing
Nottingham
NG7 2UH
United Kingdom
Sponsor information
Organisation
University of Nottingham (UK)
Sponsor details
Research Innovation Services
Kings Meadow Campus
Lenton Lane
Nottingham
NG7 2NR
United Kingdom
Sponsor type
University/education
Website
Funders
Funder type
Charity
Funder name
Arthritis Research Campaign (ARC) (UK) (ref: 17891)
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
2013 results in http://www.ncbi.nlm.nih.gov/pubmed/22701039
Publication citations
-
Results
Coole C, Drummond A, Watson PJ, Individual work support for employed patients with low back pain: a randomized controlled pilot trial., Clin Rehabil, 2013, 27, 1, 40-50, doi: 10.1177/0269215512446839.