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| Name | Class |
|---|---|
| Johannes Gutenberg University Mainz | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A high intensity | Active Comparator | Physiotherapy with high intensity and no restrictions |
|
| Group B moderate intensity | Active Comparator | Physiotherapy with medium intensity and some restrictions |
|
| Group C low intensity | Active Comparator | Physiotherapy with low intensity and many restrictions |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| high intensity physiotherapy | Procedure | high intensity exercises for 3 weeks inpatient rehabilitation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change of Oswestry Disability Index | 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 | at admission to rehabilitation clinic and at about 3 weeks at discharge |
| Measure | Description | Time Frame |
|---|---|---|
| Change of Visual Analogue Scale | Standardized tool to measure subjective pain with 0 points meaning no pain and 10 points meaning the most imaginable pain | at admission to rehabilitation clinic and at about 3 weeks at discharge |
| Recurrence rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MEDIAN Clinics | Wiesbaden | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25413281 | Result | Schroter J, Lechterbeck M, Hartmann F, Gercek E. [Structured rehabilitation after lumbar spine surgery : subacute treatment phase]. Orthopade. 2014 Dec;43(12):1089-95. doi: 10.1007/s00132-014-3051-2. German. |
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data available on reasonable request
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| ID | Term |
|---|---|
| D013001 | Somatoform Disorders |
| D013124 | Spinal Injuries |
| D012008 | Recurrence |
| D017116 | Low Back Pain |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D019567 | Back Injuries |
| D014947 | Wounds and Injuries |
| D020969 | Disease Attributes |
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3 therapy groups receiving different intensity of training
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| moderate intensity physiotherapy | Procedure | moderate intensity exercises for 3 weeks inpatient rehabilitation |
|
| low intensity physiotherapy | Procedure | low intensity exercises for 3 weeks inpatient rehabilitation |
|
Recurrence rate of lumbar spine injuries happening throughout the interventional phase
| at admission to rehabilitation clinic and at about 3 weeks at discharge |
| D010335 |
| Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |