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

NCT03433443 | Completed DMC

• 1 other identifier: UAarhus_CM_rehab
• Study Type: interventional
• Target: 82
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Spinal Fusion; Case Managers; Rehabilitation

Outcome Measures

Primary Outcomes (1)

• Oswestry Disability Index (functional disability)

  Patient reported questionnaire to measure functional disability. Scoring from 0 - 100, 0=no problems, 100=most problems. We will compare changes from baseline to two year follow-up between the two groups.

  The time frame was two years (measured from baseline to two years follow-up). Intermediate follow-up at three months, six months, nine months, one year after surgery.

Secondary Outcomes (4)

• Low Back Pain Rating Scale (measuring back and leg pain)

  The time frame was two years (measured from baseline to two years follow-up). Intermediate follow-up at three months, six months, nine months, one year after surgery.

• Return to work rates

  The time frame was two years (measured from baseline to two years follow-up)

• EuroQol 5-dimensions (Quality of Life)

  The time frame was two years (measured from baseline to two years follow-up). Intermediate follow-up at three months, six months, nine months, one year after surgery.

• Number of weeks on sick leave

  The time frame was two years (measured from baseline to two years follow-up)

Other Outcomes (6)

• Number of hours of help in the home

  The time frame was one year (measured from baseline to one year follow-up)

• Numbers of hospital out patients visits

  The time frame was two years (measured from baseline to two years follow-up)

• Numbers of contacts to private physiotherapists

  The time frame was two years (measured from baseline to two years follow-up)

Study Arms (2)

Control group

ACTIVE COMPARATOR

Usual physical rehabilitation group

Behavioral: Usual physical rehabilitation

Intervention group

EXPERIMENTAL

Case manager assisted rehabilitation

Behavioral: Case manager assisted rehabilitation; Behavioral: Usual physical rehabilitation

Interventions

Case manager assisted rehabilitation BEHAVIORAL

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.

Intervention group

Usual physical rehabilitation BEHAVIORAL

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

Control group; Intervention group

Eligibility Criteria

• Age: 18 Years - 63 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• All patients were scheduled for an lumbar spinal fusion due to degenerative disc disease or spondylolisthesis grade I or II.

You may not qualify if:

• age below 18 years or above 63 years, inability to speak and understand Danish, a driving distance of more than 100 kilometers to the hospital, un-instrumented lumbar spinal fusion, disability pension, early retirement, being out of the working force for more than 24 months, and patients under education on State education grant.

Sponsors & Collaborators

• University of Aarhus: lead

Study Officials

• Lisa G Østergaard

  Aarhus University Hospital, Department of Physiotherapy and Occupational Therapy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Due to the nature of this study it was not possible to mask the participants, care providers or the investigator. We did not use any objective outcome measures assessed by outcome assessors.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2018
• First Posted: February 14, 2018
• Study Start: April 1, 2010
• Primary Completion: October 1, 2011
• Study Completion: November 5, 2014
• Last Updated: February 14, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share