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

NCT05937997 | Completed

• 1 other identifier: WS2017
• Study Type: interventional
• Target: 245
• Locations: 1 country
• Sites: 1

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.

Conditions

Lumbar Pain Syndrome

Keywords

Enhanced recovery after surgery; spinal injuries; rehabilitation; recurrence; low back pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Change of Visual Analogue Scale

  at admission to rehabilitation clinic and at about 3 weeks at discharge

• Recurrence rate

  at admission to rehabilitation clinic and at about 3 weeks at discharge

Study Arms (3)

Group A high intensity

ACTIVE COMPARATOR

Physiotherapy with high intensity and no restrictions

Procedure: high intensity physiotherapy

Group B moderate intensity

ACTIVE COMPARATOR

Physiotherapy with medium intensity and some restrictions

Procedure: moderate intensity physiotherapy

Group C low intensity

ACTIVE COMPARATOR

Physiotherapy with low intensity and many restrictions

Procedure: low intensity physiotherapy

Interventions

high intensity physiotherapy PROCEDURE

high intensity exercises for 3 weeks inpatient rehabilitation

Group A high intensity

moderate intensity physiotherapy PROCEDURE

moderate intensity exercises for 3 weeks inpatient rehabilitation

Group B moderate intensity

low intensity physiotherapy PROCEDURE

low intensity exercises for 3 weeks inpatient rehabilitation

Group C low intensity

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• non-German speakers

Sponsors & Collaborators

• Median: lead
• Johannes Gutenberg University Mainz: collaborator

Study Sites (1)

MEDIAN Clinics

Wiesbaden, Germany

Location

Related Publications (1)

• 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.

  PMID: 25413281 RESULT

MeSH Terms

Conditions

Somatoform Disorders; Spinal Injuries; Recurrence; Low Back Pain

Condition Hierarchy (Ancestors)

Mental Disorders; Back Injuries; Wounds and Injuries; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. med. Johannes Schroeter

Model Details: 3 therapy groups receiving different intensity of training

Study Record Dates

• First Submitted: June 6, 2023
• First Posted: July 10, 2023
• Study Start: December 29, 2014
• Primary Completion: November 21, 2016
• Study Completion: November 21, 2016
• Last Updated: July 10, 2023

Record last verified: 2023-06

Locations

DE (1)