BridgeMD
New treatment option for Chronic Low-back Pain
Official title The Lumbar Interbody Fusion vs. Multidisciplinary Rehabilitation (LIFEHAB) Trial
ClinicalTrials.gov ID: NCT06169488
What this study is testing
- What it's testing
- 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?
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 20 to 65
You may be able to join 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...
- 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:
You likely can't join 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
See the full eligibility criteria
- 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Drammen, Norway
- Hagavik, Norway
- Lørenskog, Norway
- Oslo, Norway
- Trondheim, Norway
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 20 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Drammen, Norway; Hagavik, Norway; Lørenskog, Norway; Oslo, Norway; Trondheim, Norway. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.