Evaluation and Timing in an ERAS-like Structured Rehabilitation Program After Lumbar Spine Surgery
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.
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Wiesbaden, Germany
- MEDIAN Clinics
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- all patients admitted to inpatient rehabilitation facility after lumbar spine surgery
Exclusion Criteria:
- non-German speakers
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Group A high intensity
Physiotherapy with high intensity and no restrictions
|
high intensity exercises for 3 weeks inpatient rehabilitation
|
|
Active Comparator: Group B moderate intensity
Physiotherapy with medium intensity and some restrictions
|
moderate intensity exercises for 3 weeks inpatient rehabilitation
|
|
Active Comparator: Group C low intensity
Physiotherapy with low intensity and many restrictions
|
low intensity exercises for 3 weeks inpatient rehabilitation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
at admission to rehabilitation clinic and at about 3 weeks at discharge
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change of Visual Analogue Scale
Time Frame: 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
|
at admission to rehabilitation clinic and at about 3 weeks at discharge
|
|
Recurrence rate
Time Frame: at admission to rehabilitation clinic and at about 3 weeks at discharge
|
Recurrence rate of lumbar spine injuries happening throughout the interventional phase
|
at admission to rehabilitation clinic and at about 3 weeks at discharge
|
Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- WS2017
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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