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

NCT00817882 | Completed Phase 1

• 1 other identifier: 17891
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Low Back Pain

Keywords

vocational; rehabilitation; work; ability; low back pain

Outcome Measures

Primary Outcomes (1)

• work ability

  prospective

Secondary Outcomes (1)

• self-efficacy

  prospective

Study Arms (2)

1

EXPERIMENTAL

individually targeted vocational rehabilitation

Other: individually targeted vocational rehabilitation

2

ACTIVE COMPARATOR

routine back pain rehabilitation

Other: routine back pain rehabilitation

Interventions

individually targeted vocational rehabilitation 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

1

routine back pain rehabilitation OTHER

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

2

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• not fluent in English

Sponsors & Collaborators

• University of Nottingham: lead
• Arthritis Research UK: collaborator

Study Sites (1)

University of Nottingham

Nottingham, NG7 2UH, United Kingdom

Location

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Carol M Coole, MSc

  University of Nottingham

  PRINCIPAL INVESTIGATOR

• Avril Drummond, PhD

  University of Nottingham

  STUDY DIRECTOR

• Paul J Watson, PhD

  University of Leicester

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 6, 2009
• First Posted: January 7, 2009
• Study Start: May 1, 2009
• Primary Completion: July 1, 2010
• Study Completion: August 1, 2010
• Last Updated: November 23, 2010

Record last verified: 2010-11

Locations

GB (1)