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

Primary Purpose

Low Back Pain

Status

Completed

Phase

Phase 1

Locations

United Kingdom

Study Type

Interventional

Intervention

individually targeted vocational rehabilitation

routine back pain rehabilitation

About this trial

This is an interventional health services research trial for Low Back Pain focused on measuring vocational, rehabilitation, work, ability, low back pain

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University of Nottingham

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm Description

individually targeted vocational rehabilitation

routine back pain rehabilitation

Outcomes

Primary Outcome Measures

work ability

Secondary Outcome Measures

self-efficacy

Full Information

NCT ID

NCT00817882

First Posted

January 6, 2009

Last Updated

November 22, 2010

Sponsor

University of Nottingham

Collaborators

Arthritis Research UK

1. Study Identification

Unique Protocol Identification Number

NCT00817882

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2010

Overall Recruitment Status

Completed

Study Start Date

May 2009 (undefined)

Primary Completion Date

July 2010 (Actual)

Study Completion Date

August 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

University of Nottingham

Collaborators

Arthritis Research UK

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Low Back Pain

Keywords

vocational, rehabilitation, work, ability, low back pain

7. Study Design

Primary Purpose

Health Services Research

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

52 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

individually targeted vocational rehabilitation

Arm Title

Arm Type

Active Comparator

Arm Description

routine back pain rehabilitation

Intervention Type

Other

Intervention Name(s)

individually targeted vocational rehabilitation

Intervention Description

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

Intervention Name(s)

routine back pain rehabilitation

Intervention Description

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

Primary Outcome Measure Information:

Title

work ability

Time Frame

prospective

Secondary Outcome Measure Information:

Title

self-efficacy

Time Frame

prospective

10. Eligibility

Sex

All

Minimum Age & Unit of Time

16 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Carol M Coole, MSc

Organizational Affiliation

University of Nottingham

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Avril Drummond, PhD

Organizational Affiliation

University of Nottingham

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Paul J Watson, PhD

Organizational Affiliation

University of Leicester

Official's Role

Study Director

Facility Information:

Facility Name

University of Nottingham

City

Nottingham

ZIP/Postal Code

NG7 2UH

Country

United Kingdom

12. IPD Sharing Statement

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

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