NCT06169488Recruiting
The Lumbar Interbody Fusion vs. Multidisciplinary Rehabilitation (LIFEHAB) Trial
Source: ClinicalTrials.gov · Last updated 17 Mar 2026
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 202 (estimated)
- First submitted
- 22 Nov 2023
- Start date
- 15 Apr 2024
- Primary completion date
- 31 Oct 2030
- Lead sponsor
- Oslo University Hospital
- NCT number
- NCT06169488
What you commit to
- Study type: Interventional
- Planned participants: 202
- From 15 Apr 2024 to the primary completion date, 31 Oct 2030
- 5 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- History of previous spondylodiscitis
- Previous lumbar fusion surgery
Other illness
- 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)
- 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)
Other
- Multilevel disc degeneration requiring intervention beyond two levels
- Spondylolysis or lytic spondylolisthesis
- Scoliosis \>20 degrees
- Signs of a vertebral fracture at the planned level of fusion or its adjacent levels
- Active smokers
- 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
- 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
Who the study is looking for
- 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
Age in the registry: 20 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Vestre Viken Hospital Coordinator of this site? Confirm its status | Drammen | Norway | Not yet recruiting |
| Haukeland University Hospital Coordinator of this site? Confirm its status | Hagavik | Norway | Recruiting |
| Akershus University Hospital Coordinator of this site? Confirm its status | Lørenskog | Norway | Recruiting |
| Oslo University Hospital Coordinator of this site? Confirm its status | Oslo | Norway | Recruiting |
| St Olavs Hospital Coordinator of this site? Confirm its status | Trondheim | Norway | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.