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Effect of a Case Manager to Assist the Rehabilitation for Lumbar Spinal Fusion Patients. A Randomised Controlled Trial.

NCT03433443 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 82

Last updated 2018-02-14

No results posted yet for this study

Summary

The aim of the current study is to examine the effect of a case manager-assisting rehabilitation program compared to usual physical rehabilitation for patients undergoing a lumbar spinal fusion on functional disability, pain, and return to work. Furthermore, to explore if the case manager-assisted rehabilitation program is cost-effective in a societal perspective compared to usual rehabilitation.

Participants: 82 patients undergoing a lumbar spinal fusion due to disc degeneration or spondylolisthesis. Participants are adults of both gender.

Patients are included from Aarhus University Hospital, Denmark, and Region Hospital of Silkeborg, Denmark. Participants will be block randomised at each centre. The participants were randomized 1:1 to case manager-assisted rehabilitation (intervention group) or usual physical rehabilitation (control group). Both groups received usual physical rehabilitation. The patients in the intervention group meet pre-operatively with a case manager in order to set a plan for their return to daily activities and work. The intervention also included post-surgical meetings, phone meetings, work place visits, or voluntary roundtable meetings.

Conditions

  • Rehabilitation
  • Spinal Fusion
  • Case Managers

Interventions

BEHAVIORAL

Case manager assisted rehabilitation

In addition to receiving usual physical rehabilitation the patients in the intervention group had a case manager assigned. A team of three case managers delivered the intervention: a medical doctor specialized in social medicine, an occupational therapist, and a social worker. The case managers were all experienced case managers for non-surgical low back pain patients. The allocation to the case manager was random, and all patients had a main case manager assigned. The case managers involved the other case managers if their special knowledge were needed. Barriers for the patient's rehabilitation were discussed with the multidisciplinary team also including a surgeon, a physiotherapist, and a nurse.

BEHAVIORAL

Usual physical rehabilitation

The patients received usual physical rehabilitation at their community rehabilitation unit, and had no case manager assigned.

Sponsors & Collaborators

  • University of Aarhus

    lead OTHER

Principal Investigators

  • Lisa G Østergaard · Aarhus University Hospital, Department of Physiotherapy and Occupational Therapy

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
63 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-04-01
Primary Completion
2011-10-01
Completion
2014-11-05

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03433443 on ClinicalTrials.gov