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

February 7, 2018 updated by: University of Aarhus

The Effect and Cost-effectiveness of a Case Manager to Assist the Rehabilitation of Lumbar Spinal Fusion Patients. A Randomised Controlled Trial.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The past decades have seen an increase in the numbers of patients undergoing lumbar spinal surgery due to degenerative diseases in the lumbar spine. The return to work rates following a lumbar spinal fusion have been reported to be between 35 and 50 percentages one year after the surgery and between 50-63% at 2-3-year after the surgery.

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.

A total of 82 patients were included from Aarhus University Hospital, Denmark, and Region Hospital of Silkeborg, Denmark. Participants were block randomised at each centre. The participants were randomized 1:1 to case manager-assisted rehabilitation (intervention group) or usual physical rehabilitation (control group), by use of sealed envelopes. 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.

Statistical analysis:

For the power calculation, the Oswestry Disability Index was used. Based on another study in process at the time of the planning of the study, and in accordance to other research the standard deviation was set to 17 points. With a minimal clinical important difference of 12 points, a power of 80%, and a two sided significance level of 0.05, a total of 66 patients (33 in each group) should be included. I order to account for a 20% lost to follow-up a total om 80 patient should be included.

Data will be entered twice into EpiData and any divergence will be corrected according to the original material. STATA 14.1 will be used for statistical evaluation. The risk of a type 1 error was set to 5%. The data will be analyzed according to the intention-to-treat principle.

I order to compare the two groups a mixed model for repeated measurements with an unstructured covariance matrix will be used to test the effect on Oswestry Disability Index, back pain, and leg pain.

I order to evaluate the patients' return to work following the surgery, the cumulative incidence proportion of time to first spell of 4 weeks of return to work within a 2-year period will be calculated and compared by the log rank test. The relative cumulative incidens of a spell of 4 weeks' return to work will be analysed in a generalized linear regression model using the pseudo values method adjusted for time until old age pension and disability pension.

The primary outcome used in the economic evaluation are functional disability as measured by the Oswestry Disability Index. Furthermore, health-related quality of life was measured by the EuroQol 5-dimensions (EQ-5D) and valued by Danish preference weights in order to calculate Quality Adjusted Life Years (QALY).

The resource use, costs, and outcomes will be analysed as arithmetic means with 95% bootstrapped confidence intervals based on non-parametric bootstrapping (10,000 replicates), and after discounting at an annual rate of 3%. To assess the cost-effectiveness, costs and outcomes will be transformed into a uni-dimensional measure of incremental net benefit for a range of hypothetical values of willingness to pay per unit of effect: incremental net benefit = (EA - EB) * willingness to pay per effect unit - (CA - CB), where C denotes costs and E denotes effects with A and B referring to comparators.

The study protocol was approved by the Danish Data Protection Agency (J.nr.2010-41-444), and the local Ethical Committee (J.nr.M-20100038)

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
82

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 63 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Control group
Usual physical rehabilitation group
Behavioral: Usual physical rehabilitation
The patients received usual physical rehabilitation at their community rehabilitation unit, and had no case manager assigned.
Experimental: Intervention group
Case manager assisted rehabilitation
Behavioral: Usual physical rehabilitation
The patients received usual physical rehabilitation at their community rehabilitation unit, and had no case manager assigned.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Oswestry Disability Index (functional disability)
Time Frame: 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.
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Low Back Pain Rating Scale (measuring back and leg pain)
Time Frame: 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.
Patient reported questionnaire to measure back pain and leg pain on two separated sub-scales one for back pain and one for leg pain. The sub-scales ranges from 0-10, 0=no pain, 10=worst pain. 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.
Return to work rates
Time Frame: The time frame was two years (measured from baseline to two years follow-up)
Use of the national register the Danish Register for Evaluation of Marginalization (DREAM) in order to measure the cumulative incidence proportion of time to first spell of four weeks of return to work within a two-years period. The register list employment status for each week on an individual level. 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)
EuroQol 5-dimensions (Quality of Life)
Time Frame: 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.
The EuroQol 5-dimensions will be valued by Danish preference weights. Patient reported questionnaire to measure quality of life on a scale from -0.56 - 1.0. -0.56=worst possible health. 1.0 = health as a new-born. The EuroQol 5-dimensions scores will be used to calculate the Quality Adjusted Life Years as the areas under the curve. 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.
Number of weeks on sick leave
Time Frame: The time frame was two years (measured from baseline to two years follow-up)
Use of the national register the Danish Register for Evaluation of Marginalization (DREAM) in order to measure number of weeks of sick leave within a two-years period. The register list employment status for each week on an individual level. We will compare numbers of weeks of sick leave between the two groups.
The time frame was two years (measured from baseline to two years follow-up)

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of hours of help in the home
Time Frame: The time frame was one year (measured from baseline to one year follow-up)
Questionnaire to measure the patient reported use of health care services including help from family and friend, private home care, private domestic help. The measures is numbers of hours. The outcome measure will be use in the planned economic evaluation.
The time frame was one year (measured from baseline to one year follow-up)
Numbers of hospital out patients visits
Time Frame: The time frame was two years (measured from baseline to two years follow-up)
Numbers of contacts extracted from the National Patient Registry. The outcome measure will be use in the planned economic evaluation.
The time frame was two years (measured from baseline to two years follow-up)
Numbers of contacts to private physiotherapists
Time Frame: The time frame was two years (measured from baseline to two years follow-up)
Numbers of contacts extracted from The National Health Insurance Service Register. The outcome measure will be use in the planned economic evaluation.
The time frame was two years (measured from baseline to two years follow-up)
Number of contacts to medical specialist in primary care
Time Frame: The time frame was two years (measured from baseline to two years follow-up)
Numbers of contacts extracted from The National Health Insurance Service Register. The outcome measure will be use in the planned economic evaluation.
The time frame was two years (measured from baseline to two years follow-up)
Number of contacts to general practitioner
Time Frame: The time frame was two years (measured from baseline to two years follow-up)
Numbers of contacts extracted from The National Health Insurance Service Register. The outcome measure will be use in the planned economic evaluation.
The time frame was two years (measured from baseline to two years follow-up)
Number of days admitted to hospital
Time Frame: The time frame was two years (measured from baseline to two years follow-up)
Numbers of days extracted from the National Patient Registry. The outcome measure will be use in the planned economic evaluation.
The time frame was two years (measured from baseline to two years follow-up)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Aarhus

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Lisa G Østergaard, Aarhus University Hospital, Department of physiotherapy and occupational therapy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2011

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 5, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 1, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 7, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 14, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 14, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 7, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • UAarhus_CM_rehab

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

Only individual participant data that are made available in published papers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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