RehabilitationNCT03433443
Effect of a Case Manager to Assist the Rehabilitation for Lumbar Spinal Fusion Patients. A Randomised Controlled Trial.
A study testing Case manager assisted rehabilitation and Usual physical rehabilitation in people with Rehabilitation and Spinal Fusion, run by University of Aarhus.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 63 yearsHealthy volunteers can take part
- Conditions the study is for
- Rehabilitation, Spinal Fusion, Case Managers
- What is being tested?
- Case manager assisted rehabilitation and Usual physical rehabilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2010to 5 Nov 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 63 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- All patients were scheduled for an lumbar spinal fusion due to degenerative disc disease or spondylolisthesis grade I or II.
Who cannot join
- 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.
About this study
Official title: 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.
Read the 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)
- Conditions
- Rehabilitation, Spinal Fusion, Case Managers
- Being tested
- Case manager assisted rehabilitation, Usual physical rehabilitation
- Keywords
- Spinal Fusion, Case Managers, Rehabilitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Case manager assisted rehabilitationBehavioural
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.
Usual physical rehabilitationBehavioural
The patients received usual physical rehabilitation at their community rehabilitation unit, and had no case manager assigned.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | Usual physical rehabilitation group Receives: Behavioral: Usual physical rehabilitation |
| Intervention group | Experimental | Case manager assisted rehabilitation Receives: Behavioral: Case manager assisted rehabilitation; Behavioral: Usual physical rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
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.
Measured: 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
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.
Measured: The time frame was two years (measured from baseline to two years follow-up)
EuroQol 5-dimensions (Quality of Life)
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.
Measured: 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
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.
Measured: The time frame was two years (measured from baseline to two years follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2018
- Study start1 Apr 2010
- Primary completion1 Oct 2011
- Study completion5 Nov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RehabilitationStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lisa G Østergaard, Principal investigator, Aarhus University Hospital, Department of Physiotherapy and Occupational Therapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03433443
- Sponsor's protocol ID
- UAarhus_CM_rehab
- Status last verified
- Jan 2018
- First submitted
- 1 Feb 2018
- Last updated
- 14 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Only individual participant data that are made available in published papers.
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect and Cost-effectiveness of a Case Manager to Assist the Rehabilitation of Lumbar Spinal Fusion Patients. A Randomised Controlled Trial.
- ClinicalTrials.gov ID
- NCT03433443
- Acronym / sponsor ID
- UAarhus_CM_rehab
- Conditions
- Rehabilitation, Spinal Fusion, Case Managers
- Keywords
- Spinal Fusion, Case Managers, Rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- 1 Apr 2010 (actual)
- Primary completion
- 1 Oct 2011 (actual)
- Study completion
- 5 Nov 2014 (actual)
- First posted
- 14 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Behavioral: Usual physical rehabilitationUsual physical rehabilitation group |
| Intervention group | Experimental | Behavioral: Case manager assisted rehabilitation, Behavioral: Usual physical rehabilitationCase manager assisted rehabilitation |
Who may qualify
- Ages
- 18 to 63 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- All patients were scheduled for an lumbar spinal fusion due to degenerative disc disease or spondylolisthesis grade I or II.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Case manager assisted rehabilitationIn 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. | Behavioural | Intervention group |
| Usual physical rehabilitationThe patients received usual physical rehabilitation at their community rehabilitation unit, and had no case manager assigned. | Behavioural | Control group, Intervention group |
Primary outcome
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.
4 secondary outcomes
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.
Return to work rates
Time frame: 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.
Number of weeks on sick leave
Time frame: The time frame was two years (measured from baseline to two years follow-up)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2018.
- Individual participant dataSharing planned: No. Only individual participant data that are made available in published papers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lisa G Østergaard principal investigator
Aarhus University Hospital, Department of Physiotherapy and Occupational Therapy
Questions about this trial
What is this clinical trial studying?
A study testing Case manager assisted rehabilitation and Usual physical rehabilitation in people with Rehabilitation and Spinal Fusion, run by University of Aarhus.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2018.