Condition category
Musculoskeletal Diseases
Date applied
23/04/2010
Date assigned
23/04/2010
Last edited
22/07/2013
Prospective/Retrospective
Retrospectively 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

Mrs Carol Coole

ORCID ID

Contact details

Division of Rehabilitation and Ageing
B Floor Medical School
Queens Medical Centre
Derby Road
Nottingham
NG7 2UH
United Kingdom

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

http://www.nottingham.ac.uk/

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

  1. 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.

Additional files

Editorial Notes