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

Low Back Pain Clinical Trial

Official title:

Changing Perceptions of Work Ability in People With Low Back Pain: Feasibility Randomised Controlled Trial and Economic Evaluation.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00817882
• Other study ID #: 17891
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: January 6, 2009
• Last updated: November 22, 2010
• Start date: May 2009
• Est. completion date: August 2010

Study information

• Verified date: November 2010
• Source: University of Nottingham
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: August 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

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
• routine back pain rehabilitation
routine back pain rehabilitation Maximum of 25 patients with low back pain

Locations

Country	Name	City	State
United Kingdom	University of Nottingham	Nottingham

Sponsors (2)

Lead Sponsor	Collaborator
University of Nottingham	Arthritis Research UK

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	work ability		prospective	No
Secondary	self-efficacy		prospective	No