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

RecruitingNot applicableNCT06169488
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

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

Study details

Official title
The Lumbar Interbody Fusion vs. Multidisciplinary Rehabilitation (LIFEHAB) Trial
Interventions
  • Procedure: Lumbar Interbody Fusion
  • Behavioral: Multidisciplinary rehabilitation
Sponsor
Oslo University Hospital
Collaborators
University Hospital, Akershus; Haukeland University Hospital; Vestre Viken Hospital Trust; St. Olavs Hospital; Unicare
Start date
2024-04-15
Primary completion
2030-10
Sex
All
Age range
from 20 Years to 65 Years
Results posted
No results posted in this snapshot
Countries
Norway
Total sites listed
5

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
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

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT06169488