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 range
20 Years – 65 Years
Sex
ALL
See this in plain English?
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Oswestry Disability Index (ODI): Change in percent
. Multilevel disc degeneration requiring intervention beyond two levels
. Spondylolysis or lytic spondylolisthesis
. History of previous spondylodiscitis
. Previous lumbar fusion surgery
. Scoliosis \>20 degrees
. 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)