The Effect and Cost-effectiveness of a Case Manager to Assist the Rehabilitation of Lumbar Spinal Fusion Patients. A Randomised Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 82
- 主要终点
- Oswestry Disability Index (functional disability)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 63 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All patients were scheduled for an lumbar spinal fusion due to degenerative disc disease or spondylolisthesis grade I or II.
排除标准
- •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.
研究组 & 干预措施
Control group
Usual physical rehabilitation group
干预措施: Usual physical rehabilitation (Behavioral)
Intervention group
Case manager assisted rehabilitation
干预措施: Case manager assisted rehabilitation (Behavioral)
Intervention group
Case manager assisted rehabilitation
干预措施: Usual physical rehabilitation (Behavioral)
结局指标
主要结局
Oswestry Disability Index (functional disability)
时间窗: 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.
次要结局
- 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))