Clinical trial NCT05937997: Evaluation and Timing in an ERAS-like Structured Rehabilitation Program After Lumbar Spine Surgery
Official title: Evaluation and Timing in an ERAS-like Structured Rehabilitation Program After Lumbar Spine Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lumbar Pain Syndrome
Keywords: Enhanced recovery after surgery
spinal injuries
rehabilitation
recurrence
low back pain
Lead sponsor: Median
Sponsor class: OTHER
Collaborators: name: Johannes Gutenberg University Mainz
First posted: 2023-07-10
Enrollment: 245
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 3 therapy groups receiving different intensity of training
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* non-German speakers

Primary outcomes:
measure: Change of Oswestry Disability Index
timeFrame: at admission to rehabilitation clinic and at about 3 weeks at discharge
Secondary outcomes:
measure: Change of Visual Analogue Scale
timeFrame: at admission to rehabilitation clinic and at about 3 weeks at discharge
measure: Recurrence rate
timeFrame: at admission to rehabilitation clinic and at about 3 weeks at discharge
Other outcomes:
Locations:
city: Wiesbaden
country: Germany
facility: MEDIAN Clinics
Study officials:
References:
citation: 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.