The Lumbar Interbody Fusion vs. Multidisciplinary Rehabilitation (LIFEHAB) Trial (NCT06169488) | Clinical Trial Compass
RecruitingNot Applicable
The Lumbar Interbody Fusion vs. Multidisciplinary Rehabilitation (LIFEHAB) Trial
Norway202 participantsStarted 2024-04-15
Plain-language 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
Who can participate
Age range20 Years – 65 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Male and non-pregnant female patients between 20 and 65 years of age with persistent low back pain of at least one year's duration at inclusion
✓. Received non-operative treatment in line with national \[50\] and international \[49\] guidelines, including at least self-management, exercise, and physical therapy, without satisfactory effect before study enrolment
✓. Back-related disability: ODI 30 - 60 points at baseline
✓. Back pain \> leg pain
✓. One- or two-level disc degeneration between L2 and sacrum with any of the following:
Exclusion criteria
✕. Multilevel disc degeneration requiring intervention beyond two levels
✕. Spondylolysis or lytic spondylolisthesis
✕. History of previous spondylodiscitis
✕. Previous lumbar fusion surgery
✕
What they're measuring
1
Oswestry Disability Index (ODI): Change in percent
✕. Signs of a vertebral fracture at the planned level of fusion or its adjacent levels
✕. Active smokers
✕. Unlikely to adhere to treatment or complete follow-up (e.g., ongoing serious psychiatric disease, drug abuse, plans to move outside the catchment areas of the trial centers)