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RECRUITING
NCT06169488
NA

The Lumbar Interbody Fusion vs. Multidisciplinary Rehabilitation (LIFEHAB) Trial

Sponsor: Oslo University Hospital

View on ClinicalTrials.gov

Summary

The goal of this randomized controlled trial is to compare lumbar interbody fusion surgery with multidisciplinary rehabilitation in participants aged 20-65 years with persisting (≥ one year) low back pain. The main question it aims to answer is: • Is lumbar fusion surgery superior to multidisciplinary rehabilitation in alleviating persisting low back pain? Participants will be randomized to either lumbar interbody fusion surgery or a multidisciplinary rehabilitation program. If randomized to lumbar fusion interbody surgery, the participants will: * undergo radiologic examinations, including X-ray, MRI, and MRI spectroscopy * provide blood samples at four intervals including postoperatively * complete PROMs at five intervals * have their activity monitored through the ActivePAL accelerometer * undergo lumbar fusion surgery If randomized to multidisciplinary rehabilitation, the participants will: * undergo radiologic examinations, including X-ray, MRI, and MRI spectroscopy * provide blood samples at three intervals * complete PROMs at five intervals * have their activity monitored through the ActivePAL accelerometer * undergo multidisciplinary rehabilitation

Key Details

Gender

All

Age Range

20 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

202

Start Date

2024-04-15

Completion Date

2030-12

Last Updated

2026-03-17

Healthy Volunteers

No

Interventions

PROCEDURE

Lumbar Interbody Fusion

Fusion of one or two lumbar levels with either a transforaminal lumbar interbody fusion (TLIF) or an anterior lumbar interbody fusion (ALIF) procedure.

BEHAVIORAL

Multidisciplinary rehabilitation

Outpatient multidisciplinary rehabilitation based on the treatment model described by Brox et al and Hellum et al consisting of a cognitive approach and supervised physical and functional training, but the protocol is somewhat compressed in terms of time and additionally updated in line with recent years' research in cognitive functional rehabilitation.

Locations (5)

Vestre Viken Hospital

Drammen, Norway

Haukeland University Hospital

Hagavik, Norway

Akershus University Hospital

Lørenskog, Norway

Oslo University Hospital

Oslo, Norway

St. Olavs Hospital

Trondheim, Norway