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

June 27, 2023 updated by: Johannes Schroeter, Median

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

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

245

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Wiesbaden, Germany
        • MEDIAN Clinics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • all patients admitted to inpatient rehabilitation facility after lumbar spine surgery

Exclusion Criteria:

  • non-German speakers

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
Procedure: high intensity physiotherapy
high intensity exercises for 3 weeks inpatient rehabilitation
Active Comparator: Group B moderate intensity
Physiotherapy with medium intensity and some restrictions
Procedure: moderate intensity physiotherapy
moderate intensity exercises for 3 weeks inpatient rehabilitation
Active Comparator: Group C low intensity
Physiotherapy with low intensity and many restrictions
Procedure: low intensity physiotherapy
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

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

This is where you will find people and organizations involved with this study.

Sponsor

Median

Collaborators

Johannes Gutenberg University Mainz

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 29, 2014

Primary Completion (Actual)

November 21, 2016

Study Completion (Actual)

November 21, 2016

Study Registration Dates

First Submitted

June 6, 2023

First Submitted That Met QC Criteria

June 27, 2023

First Posted (Actual)

July 10, 2023

Study Record Updates

Last Update Posted (Actual)

July 10, 2023

Last Update Submitted That Met QC Criteria

June 27, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WS2017

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

data available on reasonable request

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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