The Lumbar Interbody Fusion vs. Multidisciplinary Rehabilitation (LIFEHAB) Trial

Recruiting now · Not applicable

Conditions studied: Chronic Low-back Pain

In brief

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

Key facts

Study ID

NCT06169488

Run by

Oslo University Hospital

People needed

202

Starts

2024-04-15

Expected to finish

2030-12-01

Last updated by the study team

2026-03-17

Who can join

Age: 20 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Haukeland University Hospital — Hagavik, Norway (enrolling)
• Akershus University Hospital — Lørenskog, Norway (enrolling)
• Oslo University Hospital — Oslo, Norway (enrolling)
• St. Olavs Hospital — Trondheim, Norway (enrolling)
• Vestre Viken Hospital — Drammen, Norway

Full record on ClinicalTrials.gov

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