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

Median Technologies

Status: Completed

Conditions: Lumbar Pain Syndrome

Treatments: Procedure: low intensity physiotherapy; Procedure: moderate intensity physiotherapy; Procedure: high intensity physiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT05937997

WS2017

Details and patient eligibility

About

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.

Full 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.

Enrollment: 245 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• non-German speakers

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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245 participants in 3 patient groups

Group A high intensity

Active Comparator group

Description:

Physiotherapy with high intensity and no restrictions

Treatment:

Procedure: high intensity physiotherapy

Group B moderate intensity

Active Comparator group

Description:

Physiotherapy with medium intensity and some restrictions

Treatment:

Procedure: moderate intensity physiotherapy

Group C low intensity

Active Comparator group

Description:

Physiotherapy with low intensity and many restrictions

Treatment:

Procedure: low intensity physiotherapy