Evaluation and Timing in an ERAS-like Structured Rehabilitation Program After Lumbar Spine Surgery

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Evaluation and Timing in an ERAS-like Structured Rehabilitation Program After Lumbar Spine Surgery

Conditions
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Lumbar Pain Syndrome

Intervention / Treatment
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* Procedure: high intensity physiotherapy
* Procedure: moderate intensity physiotherapy
* Procedure: low intensity physiotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: all patients admitted to inpatient rehabilitation facility after lumbar spine surgery Exclusion Criteria: non-German speakers
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 3 therapy groups receiving different intensity of training
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group A high intensity<br>Physiotherapy with high intensity and no restrictions | Procedure: high intensity physiotherapy<br>* high intensity exercises for 3 weeks inpatient rehabilitation<br>|
| Active Comparator: Group B moderate intensity<br>Physiotherapy with medium intensity and some restrictions | Procedure: moderate intensity physiotherapy<br>* moderate intensity exercises for 3 weeks inpatient rehabilitation<br>|
| Active Comparator: Group C low intensity<br>Physiotherapy with low intensity and many restrictions | Procedure: low intensity physiotherapy<br>* low intensity exercises for 3 weeks inpatient rehabilitation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | Recurrence rate of lumbar spine injuries happening throughout the interventional phase | at admission to rehabilitation clinic and at about 3 weeks at discharge | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Enhanced recovery after surgery, spinal injuries, rehabilitation, recurrence, low back pain