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

Not Applicable

Completed

• Conditions: Lumbar Pain Syndrome
• Interventions: Procedure: moderate intensity physiotherapy; Procedure: low intensity physiotherapy; Procedure: high intensity physiotherapy

• Registration Number: NCT05937997
• Lead Sponsor: Median

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.

Study Timeline

• Study Start: 2014-12-29
• Primary Completion: 2016-11-21
• Study Completion: 2016-11-21
• Status Verified: 2023-06
• Study First Submitted: 2023-06-06
• Study First Submitted QC: 2023-06-27
• Last Update Submitted: 2023-06-27
• Study First Posted: 2023-07-10
• Last Update Posted: 2023-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 245

Inclusion Criteria

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

Exclusion Criteria

• non-German speakers

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group B moderate intensity	moderate intensity physiotherapy	Physiotherapy with medium intensity and some restrictions
Group C low intensity	low intensity physiotherapy	Physiotherapy with low intensity and many restrictions
Group A high intensity	high intensity physiotherapy	Physiotherapy with high intensity and no restrictions

Primary Outcome Measures

Name	Time	Method
Change of Oswestry Disability Index	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 Outcome Measures

Name	Time	Method
Change of Visual Analogue Scale	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
Recurrence rate	at admission to rehabilitation clinic and at about 3 weeks at discharge	Recurrence rate of lumbar spine injuries happening throughout the interventional phase

Trial Locations

Locations (1)

MEDIAN Clinics; 🇩🇪 Wiesbaden, Germany