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

Primary Purpose

Lumbar Pain Syndrome

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
high intensity physiotherapy
moderate intensity physiotherapy
low intensity physiotherapy
Sponsored by
Median
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lumbar Pain Syndrome focused on measuring Enhanced recovery after surgery, spinal injuries, rehabilitation, recurrence, low back pain

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: all patients admitted to inpatient rehabilitation facility after lumbar spine surgery Exclusion Criteria: non-German speakers

Sites / Locations

  • MEDIAN Clinics

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Group A high intensity

Group B moderate intensity

Group C low intensity

Arm Description

Physiotherapy with high intensity and no restrictions

Physiotherapy with medium intensity and some restrictions

Physiotherapy with low intensity and many restrictions

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
Recurrence rate
Recurrence rate of lumbar spine injuries happening throughout the interventional phase

Full Information

First Posted
June 6, 2023
Last Updated
June 27, 2023
Sponsor
Median
Collaborators
Johannes Gutenberg University Mainz
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1. Study Identification

Unique Protocol Identification Number
NCT05937997
Brief Title
Evaluation and Timing in an ERAS-like Structured Rehabilitation Program After Lumbar Spine Surgery
Official Title
Evaluation and Timing in an ERAS-like Structured Rehabilitation Program After Lumbar Spine Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
December 29, 2014 (Actual)
Primary Completion Date
November 21, 2016 (Actual)
Study Completion Date
November 21, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Median
Collaborators
Johannes Gutenberg University Mainz

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lumbar Pain Syndrome
Keywords
Enhanced recovery after surgery, spinal injuries, rehabilitation, recurrence, low back pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
3 therapy groups receiving different intensity of training
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
245 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A high intensity
Arm Type
Active Comparator
Arm Description
Physiotherapy with high intensity and no restrictions
Arm Title
Group B moderate intensity
Arm Type
Active Comparator
Arm Description
Physiotherapy with medium intensity and some restrictions
Arm Title
Group C low intensity
Arm Type
Active Comparator
Arm Description
Physiotherapy with low intensity and many restrictions
Intervention Type
Procedure
Intervention Name(s)
high intensity physiotherapy
Intervention Description
high intensity exercises for 3 weeks inpatient rehabilitation
Intervention Type
Procedure
Intervention Name(s)
moderate intensity physiotherapy
Intervention Description
moderate intensity exercises for 3 weeks inpatient rehabilitation
Intervention Type
Procedure
Intervention Name(s)
low intensity physiotherapy
Intervention Description
low intensity exercises for 3 weeks inpatient rehabilitation
Primary Outcome Measure Information:
Title
Change of Oswestry Disability Index
Description
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
Time Frame
at admission to rehabilitation clinic and at about 3 weeks at discharge
Secondary Outcome Measure Information:
Title
Change of Visual Analogue Scale
Description
Standardized tool to measure subjective pain with 0 points meaning no pain and 10 points meaning the most imaginable pain
Time Frame
at admission to rehabilitation clinic and at about 3 weeks at discharge
Title
Recurrence rate
Description
Recurrence rate of lumbar spine injuries happening throughout the interventional phase
Time Frame
at admission to rehabilitation clinic and at about 3 weeks at discharge

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: all patients admitted to inpatient rehabilitation facility after lumbar spine surgery Exclusion Criteria: non-German speakers
Facility Information:
Facility Name
MEDIAN Clinics
City
Wiesbaden
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
data available on reasonable request
Citations:
PubMed Identifier
25413281
Citation
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.
Results Reference
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Evaluation and Timing in an ERAS-like Structured Rehabilitation Program After Lumbar Spine Surgery

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