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

NCT ID: NCT00817882

Last Updated: 2010-11-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-05-31

Study Completion Date

2010-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Low Back Pain

Keywords

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vocational rehabilitation work ability low back pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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1

individually targeted vocational rehabilitation

Group Type EXPERIMENTAL

individually targeted vocational rehabilitation

Intervention Type OTHER

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

2

routine back pain rehabilitation

Group Type ACTIVE_COMPARATOR

routine back pain rehabilitation

Intervention Type OTHER

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

Interventions

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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

Intervention Type OTHER

routine back pain rehabilitation

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Arthritis Research UK

OTHER

Sponsor Role collaborator

University of Nottingham

OTHER

Sponsor Role lead

Responsible Party

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University of Nottingham

Principal Investigators

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Carol M Coole, MSc

Role: PRINCIPAL_INVESTIGATOR

University of Nottingham

Avril Drummond, PhD

Role: STUDY_DIRECTOR

University of Nottingham

Paul J Watson, PhD

Role: STUDY_DIRECTOR

University of Leicester

Locations

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University of Nottingham

Nottingham, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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17891

Identifier Type: -

Identifier Source: org_study_id