The Lumbar Interbody Fusion vs. Multidisciplinary Rehabilitation (LIFEHAB) Trial
ConditionChronic Low-back Pain
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-65
SponsorOslo University Hospital
About this trial
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
Qualifiers
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
Disqualifiers
Multilevel disc degeneration requiring intervention beyond two levels
Spondylolysis or lytic spondylolisthesis
History of previous spondylodiscitis
Previous lumbar fusion surgery
Trial design
Treatments tested in this trial
- Lumbar Interbody Fusion
- Multidisciplinary rehabilitation
Treatment groups
202 Participants
are divided into 2 treatment groupsSponsors and collaborators
Oslo University Hospital
Lead sponsor
University Hospital, Akershus
Collaborator
Haukeland University Hospital
Collaborator
Vestre Viken Hospital Trust
Collaborator
St. Olavs Hospital
Collaborator
Unicare
Collaborator
Source ClinicalTrials.gov