Evaluation and Timing in an ERAS-like Structured Rehabilitation Program After Lumbar Spine Surgery
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Lumbar Pain Syndrome
- Sponsor
- Median
- Enrollment
- 245
- Locations
- 1
- Primary Endpoint
- Change of Oswestry Disability Index
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
The goal of this clinical trial is to investigate the safety of early inpatient rehabilitation after lumbar spine surgery.
Participants are assigned to therapy groups C (low) - A (high) intensity and receive standardized multimodal rehabilitation for 3 weeks. Groups are compared in terms of safety, disability impairment as well as pain. Timing of rehabilitation is considered.
Detailed Description
Purpose Literature on early rehabilitation after lumbar spine surgery trends towards a structurized program beginning in the post-acute phase, but publications are rare. Therefore, this study was conducted to investigate the safety of early rehabilitation according to ERAS® principles after different lumbar spine surgeries with regard to training intensity and timing of rehabilitation. Methods Study design was prospective, non-randomized, and multicentric (3 inpatient rehabilitation facilities in Germany). Based on the senior rehabilitation physician's assessment for patient's physical capacity, patients were assigned to therapy groups C - A (low - high intensity). For statistical analysis patients were also grouped in 3 different time intervals depending on days past surgery until rehabilitation start and. Safety (recurrence rates), disability (Oswestry Disability Index (ODI)), and pain (Visual Analogue Scale (VAS)), were measured at the beginning and at the end of rehabilitation stay. Scores were compared between 3 therapy groups and 3 time intervals for within- and between-group differences. Analgesics and back orthesis use was assessed and analysed as well.
Investigators
Johannes Schroeter
Dr. med. Johannes Schroeter
Median
Eligibility Criteria
Inclusion Criteria
- •all patients admitted to inpatient rehabilitation facility after lumbar spine surgery
Exclusion Criteria
- •non-German speakers
Outcomes
Primary Outcomes
Change of Oswestry Disability Index
Time Frame: at admission to rehabilitation clinic and at about 3 weeks at discharge
Questionnaire with 10 items to evaluate the disability from back pain, results presented in precentage with 0 % experiencing no disability because of back issues and with 100 % experiencing the most disability because of back issues
Secondary Outcomes
- Change of Visual Analogue Scale(at admission to rehabilitation clinic and at about 3 weeks at discharge)
- Recurrence rate(at admission to rehabilitation clinic and at about 3 weeks at discharge)