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OpenTrials
Completed

NCT Number: NCT05937997

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.

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Key information

Conditions

Lumbar Pain Syndrome Back Injuries Back Pain Disease Attributes Low Back Pain Mental Disorders Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence Signs and Symptoms Somatoform Disorders Spinal Injuries Wounds and Injuries

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

MEDIAN Clinics

Wiesbaden, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • non-German speakers

Treatment and study plan

high intensity physiotherapy

Procedure

high intensity exercises for 3 weeks inpatient rehabilitation

moderate intensity physiotherapy

Procedure

moderate intensity exercises for 3 weeks inpatient rehabilitation

low intensity physiotherapy

Procedure

low intensity exercises for 3 weeks inpatient rehabilitation

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

Median

Other

Collaborators

  • Johannes Gutenberg University Mainz

Registry information

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Jul 10, 2023
Registry last updated
Jul 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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