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

This study has been completed.
Sponsor:
Collaborator:
Arthritis Research UK
Information provided by:
University of Nottingham
ClinicalTrials.gov Identifier:
NCT00817882
First received: January 6, 2009
Last updated: November 22, 2010
Last verified: November 2010
  Purpose

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 Intervention Phase
Low Back Pain
Other: individually targeted vocational rehabilitation
Other: routine back pain rehabilitation
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by University of Nottingham:

Primary Outcome Measures:
  • work ability [ Time Frame: prospective ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • self-efficacy [ Time Frame: prospective ] [ Designated as safety issue: No ]

Enrollment: 52
Study Start Date: May 2009
Study Completion Date: August 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00817882

Locations
United Kingdom
University of Nottingham
Nottingham, United Kingdom, NG7 2UH
Sponsors and Collaborators
University of Nottingham
Arthritis Research UK
Investigators
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
  More Information

No publications provided

Responsible Party: Paul Cartledge, University of Nottingham
ClinicalTrials.gov Identifier: NCT00817882     History of Changes
Other Study ID Numbers: 17891
Study First Received: January 6, 2009
Last Updated: November 22, 2010
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by University of Nottingham:
vocational
rehabilitation
work
ability
low back pain

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

ClinicalTrials.gov processed this record on October 19, 2014