Evaluation and Timing in an ERAS-like Structured Rehabilitation Program After Lumbar Spine Surgery
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Group A high intensity Physiotherapy with high intensity and no restrictions |
Procedure: high intensity physiotherapy
high intensity exercises for 3 weeks inpatient rehabilitation
|
| Active Comparator: Group B moderate intensity Physiotherapy with medium intensity and some restrictions |
Procedure: moderate intensity physiotherapy
moderate intensity exercises for 3 weeks inpatient rehabilitation
|
| Active Comparator: Group C low intensity Physiotherapy with low intensity and many restrictions |
Procedure: low intensity physiotherapy
low intensity exercises for 3 weeks inpatient rehabilitation
|
Outcome Measures
Primary Outcome Measures
- Change of Oswestry Disability Index [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 Outcome Measures
- Change of Visual Analogue Scale [at admission to rehabilitation clinic and at about 3 weeks at discharge]
Standardized tool to measure subjective pain with 0 points meaning no pain and 10 points meaning the most imaginable pain
- Recurrence rate [at admission to rehabilitation clinic and at about 3 weeks at discharge]
Recurrence rate of lumbar spine injuries happening throughout the interventional phase
Eligibility Criteria
Criteria
Inclusion Criteria:
- all patients admitted to inpatient rehabilitation facility after lumbar spine surgery
Exclusion Criteria:
- non-German speakers
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | MEDIAN Clinics | Wiesbaden | Germany |
Sponsors and Collaborators
- Median
- Johannes Gutenberg University Mainz
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- WS2017