NCT05937997

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 245 (actual)
• Sponsor: Median · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Lumbar Pain Syndrome

Interventions

Type	Name	Description
PROCEDURE	high intensity physiotherapy	high intensity exercises for 3 weeks inpatient rehabilitation
PROCEDURE	moderate intensity physiotherapy	moderate intensity exercises for 3 weeks inpatient rehabilitation
PROCEDURE	low intensity physiotherapy	low intensity exercises for 3 weeks inpatient rehabilitation

Timeline

• Start date: 2014-12-29
• Primary completion: 2016-11-21
• Completion: 2016-11-21
• First posted: 2023-07-10
• Last updated: 2023-07-10

Locations

1 site across 1 country: Germany