NCT06169488 The Lumbar Interbody Fusion vs. Multidisciplinary Rehabilitation (LIFEHAB) Trial
| NCT ID | NCT06169488 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Oslo University Hospital |
| Condition | Chronic Low-back Pain |
| Study Type | INTERVENTIONAL |
| Enrollment | 202 participants |
| Start Date | 2024-04-15 |
| Primary Completion | 2030-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 202 participants in total. It began in 2024-04-15 with a primary completion date of 2030-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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 Criteria
Inclusion Criteria: 1. 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 2. 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 3. Back-related disability: ODI 30 - 60 points at baseline 4. Back pain \> leg pain 5. 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 Criteria: 1. Multilevel disc degeneration requiring intervention beyond two levels 2. Spondylolysis or lytic spondylolisthesis 3. History of previous spondylodiscitis 4. Previous lumbar fusion surgery 5. Scoliosis \>20 degrees 6. Signs of a vertebral fracture at the planned level of fusion or its adjacent levels 7. Active smokers 8. 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) 9. Significant nerve root compression assessed by MRI and clinical examination 10. BMI \> 40 11. Not understanding the Norwegian language. 12. Generalized myalgia, including history or signs of fibromyalgia and myalgic encephalitis 13. Contraindications to MRI (e.g., cardiac pacemaker electrodes, metal implants in the eye or brain, claustrophobia). 14. Active cancer 15. Disabling chronic neurological disease (e.g., Parkinson's disease, ALS, MS) 16. Disabling osteoarthritis of the hip or knee (Kellgren \& Lawrence grade III or higher) 17. Daily use of morphine equivalents ≥ 60mg or regular use of morphine-containing pain patches 18. Decline specific treatment arm
Contact & Investigator
Christian Hellum, PhD
PRINCIPAL INVESTIGATOR
Oslo University Hospital, Division of Orthopedic Surgery, OUS Ullevål
Frequently Asked Questions
Who can join the NCT06169488 clinical trial?
This trial is open to participants of all sexes, aged 20 Years or older, up to 65 Years, studying Chronic Low-back Pain. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06169488 currently recruiting?
Yes, NCT06169488 is actively recruiting participants. Contact the research team at svemjo@ahus.no for enrollment information.
Where is the NCT06169488 trial being conducted?
This trial is being conducted at Drammen, Norway, Hagavik, Norway, Lørenskog, Norway, Oslo, Norway and 1 additional location.
Who is sponsoring the NCT06169488 clinical trial?
NCT06169488 is sponsored by Oslo University Hospital. The principal investigator is Christian Hellum, PhD at Oslo University Hospital, Division of Orthopedic Surgery, OUS Ullevål. The trial plans to enroll 202 participants.