Working Well With Back Pain (Feasibility RCT of Vocational Rehabilitation)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00817882
Recruitment Status : Completed
First Posted : January 7, 2009
Last Update Posted : November 23, 2010
Arthritis Research UK
Information provided by:
University of Nottingham

Brief Summary:
Back pain has a major impact on people's ability to work. Health professionals need to know how they can best use their limited resources to address the occupational needs of people with chronic low back pain. Vocational rehabilitation is the process that helps people with health problems to stay at, return to and remain at work. This study comprises the second phase of a three year study of back pain and vocational rehabilitation. The first phase gathered data from patient interviews and postal surveys of GPs and GP practice managers. These findings have been used to inform this second phase; a feasibility randomised controlled trial. The participants will be thirty employed people with back pain who have been offered an NHS rehabilitation programme, and who are concerned about their ability to work with low back pain. Those who consent will be randomised into two groups. One group will receive routine rehabilitation. The other will receive routine rehabilitation plus an individually tailored vocational intervention carried out by the researcher. Following the trial, individual interviews will be carried out with each of the participants by an independent researcher. An economic study will evaluate the possibility of measuring the cost-effectiveness of the intervention. The hypothesis is that an enhanced vocational intervention plus routine rehabilitation will be more effective in improving patients' work ability than routine rehabilitation alone.

Condition or disease Intervention/treatment Phase
Low Back Pain Other: individually targeted vocational rehabilitation Other: routine back pain rehabilitation Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Changing Perceptions of Work Ability in People With Low Back Pain: Feasibility Randomised Controlled Trial and Economic Evaluation.
Study Start Date : May 2009
Actual Primary Completion Date : July 2010
Actual Study Completion Date : August 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1
individually targeted vocational rehabilitation
Other: individually targeted vocational rehabilitation

individually targeted vocational rehabilitation over 4 month period, maximum of 10 sessions, in addition to routine back pain rehabilitation.

Maximum of 25 participants with low back pain

Active Comparator: 2
routine back pain rehabilitation
Other: routine back pain rehabilitation
routine back pain rehabilitation Maximum of 25 patients with low back pain

Primary Outcome Measures :
  1. work ability [ Time Frame: prospective ]

Secondary Outcome Measures :
  1. self-efficacy [ Time Frame: prospective ]

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • low back pain
  • offered routine rehabilitation
  • employed
  • concern about work ability due to low back pain
  • referral by GP in South Nottinghamshire

Exclusion Criteria:

  • not fluent in English

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00817882

United Kingdom
University of Nottingham
Nottingham, United Kingdom, NG7 2UH
Sponsors and Collaborators
University of Nottingham
Arthritis Research UK
Principal Investigator: Carol M Coole, MSc University of Nottingham
Study Director: Avril Drummond, PhD University of Nottingham
Study Director: Paul J Watson, PhD University of Leicester

Responsible Party: Paul Cartledge, University of Nottingham Identifier: NCT00817882     History of Changes
Other Study ID Numbers: 17891
First Posted: January 7, 2009    Key Record Dates
Last Update Posted: November 23, 2010
Last Verified: November 2010

Keywords provided by University of Nottingham:
low back pain

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms