Status:
RECRUITING
The Lumbar Interbody Fusion vs. Multidisciplinary Rehabilitation (LIFEHAB) Trial
Lead Sponsor:
Oslo University Hospital
Collaborating Sponsors:
University Hospital, Akershus
Haukeland University Hospital
Conditions:
Chronic Low-back Pain
Eligibility:
All Genders
20-65 years
Phase:
NA
Brief 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 ...
Detailed Description
Background: Low back pain (LBP) is the number one cause of disability worldwide. Chronic LBP (cLBP), also referred to as persisting low back pain, is defined as low back pain lasting at least twelve w...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 15 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2030
Estimated Enrollment :
202 Patients enrolled
Trial Details
Trial ID
NCT06169488
Start Date
April 15 2024
End Date
December 1 2030
Last Update
April 29 2025
Active Locations (5)
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1
Vestre Viken Hospital
Drammen, Norway
2
Haukeland University Hospital
Hagavik, Norway
3
Akershus University Hospital
Lørenskog, Norway
4
Oslo University Hospital
Oslo, Norway