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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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Lumbar Interbody Fusion

    Procedure/Surgery

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

  • Multidisciplinary rehabilitation

    Behavioral

    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.

Treatment groups

202 Participants
are divided into 2 treatment groups
Group A: Lumbar Interbody Fusion (LIF)Experimental treatment 1 intervention
Group B: Multidisciplinary RehabilitationActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Oswestry Disability Index (ODI): Change in percent

Improvement in the ODI score of a minimum of 30% from baseline. The ODI questionnaire examines the level of disability based on 10 everyday activities of daily living. Each item consists of 6 statements which are scored from 0 to 5, with 0 indicating the least disability and 5 the highest level of disability. The total score is calculated as a percentage, with 0% indicating no disability and 100% indicating the highest level of disability.

Time frame
At one-year follow-up

Secondary outcomes

1

Oswestry Disability Index (ODI): Dichotomized

ODI dichotomized as a Positive response: PASS (ODI≤22), i.e., participant reaches a Patient Acceptable Symptom State or a Negative response (ODI \>22).

Time frame
At one-year follow-up
2

Oswestry Disability Index (ODI): Continuous

Change in ODI from baseline (continuous variable)

Time frame
At one-year follow-up
3

Numeric Rating Scale back pain (NRS back pain)

Change in NRS back pain from baseline (continuous variable). The NRS is a 11-point numeric scale ranging from '0' (e.g. "no pain") to '10' (e.g. "worst possible pain").

Time frame
At one-year follow-up
4

Numeric Rating Scale leg pain (NRS leg pain)

Change in NRS leg pain from baseline (continuous variable). The NRS is a 11-point numeric scale ranging from '0' (e.g. "no pain") to '10' (e.g. "worst possible pain").

Time frame
At one-year follow-up

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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
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