Evaluation and Timing in an ERAS-like Structured Rehabilitation Program After Lumbar Spine Surgery
NCT ID: NCT05937997
Last Updated: 2023-07-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
245 participants
INTERVENTIONAL
2014-12-29
2016-11-21
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Group A high intensity
Physiotherapy with high intensity and no restrictions
high intensity physiotherapy
high intensity exercises for 3 weeks inpatient rehabilitation
Group B moderate intensity
Physiotherapy with medium intensity and some restrictions
moderate intensity physiotherapy
moderate intensity exercises for 3 weeks inpatient rehabilitation
Group C low intensity
Physiotherapy with low intensity and many restrictions
low intensity physiotherapy
low intensity exercises for 3 weeks inpatient rehabilitation
Interventions
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high intensity physiotherapy
high intensity exercises for 3 weeks inpatient rehabilitation
moderate intensity physiotherapy
moderate intensity exercises for 3 weeks inpatient rehabilitation
low intensity physiotherapy
low intensity exercises for 3 weeks inpatient rehabilitation
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
ALL
No
Sponsors
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Johannes Gutenberg University Mainz
OTHER
Median
OTHER
Responsible Party
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Johannes Schroeter
Dr. med. Johannes Schroeter
Locations
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MEDIAN Clinics
Wiesbaden, , Germany
Countries
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References
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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.
Other Identifiers
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WS2017
Identifier Type: -
Identifier Source: org_study_id
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