Comparing lumbar fusion surgery to rehabilitation for chronic low back pain
The Lumbar Interbody Fusion vs. Multidisciplinary Rehabilitation (LIFEHAB) Trial
This study is testing whether lumbar fusion surgery or a rehabilitation program works better for people aged 20-65 with chronic low back pain lasting more than a year.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 202 (estimated) |
| Ages | 20 Years to 65 Years |
| Sex | All |
| Sponsor | Oslo University Hospital Academic / other |
| Locations | 5 sites (Drammen and 4 other locations) |
| Trial ID | NCT06169488 on ClinicalTrials.gov |
What this trial studies
This trial aims to evaluate the effectiveness of lumbar interbody fusion surgery versus a multidisciplinary rehabilitation program for individuals aged 20-65 suffering from chronic low back pain lasting over a year. Participants will be randomly assigned to either treatment group and will undergo various assessments, including radiologic examinations and activity monitoring. The study seeks to determine which approach provides better relief from persistent low back pain and improves patient outcomes.
Who should consider this trial
Good fit: Ideal candidates are males and non-pregnant females aged 20-65 with chronic low back pain lasting at least one year and who have not found relief from previous non-operative treatments.
Not a fit: Patients with multilevel disc degeneration or those who have previously undergone lumbar fusion surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide clearer guidance on the most effective treatment for chronic low back pain, potentially improving patient quality of life.
How similar studies have performed: Previous studies have explored various treatments for chronic low back pain, but this direct comparison of surgical versus rehabilitation approaches is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Drammen and 4 other locations
- Vestre Viken Hospital — Drammen, Norway (Not_yet_recruiting)
- Haukeland University Hospital — Hagavik, Norway (Recruiting)
- Akershus University Hospital — Lørenskog, Norway (Recruiting)
- Oslo University Hospital — Oslo, Norway (Recruiting)
- St. Olavs Hospital — Trondheim, Norway (Recruiting)
Study contacts
- Principal investigator: Christian Hellum, PhD — Oslo University Hospital, Division of Orthopedic Surgery, OUS Ullevål
- Study coordinator: Sverre Mjønes, MD
- Email: svemjo@ahus.no
- Phone: +4767960000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.