The Lumbar Interbody Fusion vs. Multidisciplinary Rehabilitation (LIFEHAB) Trial
Oslo University Hospital
202 participants
Apr 15, 2024
INTERVENTIONAL
Conditions
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
Eligibility
Inclusion Criteria8
- 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:
- High-intensity zone (HiZ)
- Modic changes
- Severe disc height reduction exceeding 50% of the cranial disc
Exclusion Criteria18
- 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)
- Significant nerve root compression assessed by MRI and clinical examination
- BMI \> 40
- Not understanding the Norwegian language.
- Generalized myalgia, including history or signs of fibromyalgia and myalgic encephalitis
- Contraindications to MRI (e.g., cardiac pacemaker electrodes, metal implants in the eye or brain, claustrophobia).
- Active cancer
- Disabling chronic neurological disease (e.g., Parkinson's disease, ALS, MS)
- Disabling osteoarthritis of the hip or knee (Kellgren \& Lawrence grade III or higher)
- Daily use of morphine equivalents ≥ 60mg or regular use of morphine-containing pain patches
- Decline specific treatment arm
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Interventions
Fusion of one or two lumbar levels with either a transforaminal lumbar interbody fusion (TLIF) or an anterior lumbar interbody fusion (ALIF) procedure.
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)
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NCT06169488