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

Summary

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

Conditions

• Chronic Low-back Pain

Interventions

PROCEDURE

Lumbar Interbody Fusion

Fusion of one or two lumbar levels with either a transforaminal lumbar interbody fusion (TLIF) or an anterior lumbar interbody fusion (ALIF) procedure.

BEHAVIORAL

Multidisciplinary rehabilitation

Outpatient multidisciplinary rehabilitation based on the treatment model described by Brox et al and Hellum et al consisting of a cognitive approach and supervised physical and functional training, but the protocol is somewhat compressed in terms of time and additionally updated in line with recent years' research in cognitive functional rehabilitation.

Sponsors & Collaborators

• University Hospital, Akershus

  collaborator OTHER

• Haukeland University Hospital

  collaborator OTHER

• Vestre Viken Hospital Trust

  collaborator OTHER

• St. Olavs Hospital

  collaborator OTHER

• Unicare

  collaborator UNKNOWN

• Oslo University Hospital

  lead OTHER

Principal Investigators

• Christian Hellum, PhD · Oslo University Hospital, Division of Orthopedic Surgery, OUS Ullevål

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

20 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-04-15

Primary Completion

2030-10-31

Completion

2030-12-31

Countries

• Norway

Study Locations