Actively Recruiting
The Lumbar Interbody Fusion vs. Multidisciplinary Rehabilitation (LIFEHAB) Trial
Led by Oslo University Hospital · Updated on 2026-03-17
202
Participants Needed
5
Research Sites
345 weeks
Total Duration
On this page
Sponsors
O
Oslo University Hospital
Lead Sponsor
U
University Hospital, Akershus
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
The Lumbar Interbody Fusion vs. Multidisciplinary Rehabilitation (LIFEHAB) Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male and non-pregnant female patients aged 20 to 65 years with low back pain lasting at least one year
- Received non-operative treatments including self-management, exercise, and physical therapy without satisfactory effect
- Back-related disability with Oswestry Disability Index (ODI) between 30 and 60 points at baseline
- Back pain greater than leg pain
- One- or two-level disc degeneration between L2 and sacrum with high-intensity zone, Modic changes, or severe disc height reduction exceeding 50% of the cranial disc
You will not qualify if you...
- Multilevel disc degeneration needing treatment beyond two levels
- Spondylolysis or lytic spondylolisthesis
- Previous history of spondylodiscitis
- Prior lumbar fusion surgery
- Scoliosis greater than 20 degrees
- Signs of vertebral fracture at planned fusion level or adjacent levels
- Active smoking status
- Unlikely to adhere to treatment or complete follow-up (e.g., serious psychiatric disease, drug abuse, plans to move away)
- Significant nerve root compression by MRI and clinical exam
- Body mass index (BMI) over 40
- Inability to understand Norwegian language
- Generalized myalgia including fibromyalgia or myalgic encephalitis
- Contraindications to MRI such as pacemaker, metal implants, or claustrophobia
- Active cancer
- Disabling chronic neurological diseases like Parkinson's, ALS, or MS
- Disabling osteoarthritis of hip or knee (Kellgren & Lawrence grade III or higher)
- Daily morphine use of 60 mg or more or regular morphine-containing pain patch use
- Decline of specific treatment arm participation
AI-Screening
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Trial Site Locations
Total: 5 locations
1
Vestre Viken Hospital
Drammen, Norway
Not Yet Recruiting
2
Haukeland University Hospital
Hagavik, Norway
Actively Recruiting
3
Akershus University Hospital
Lørenskog, Norway
Actively Recruiting
4
Oslo University Hospital
Oslo, Norway
Actively Recruiting
5
St. Olavs Hospital
Trondheim, Norway
Actively Recruiting
Research Team
S
Sverre Mjønes, MD
CONTACT
K
Kjersti Storheim, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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