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

NCT06169488 | Recruiting

• 1 other identifier: 506009
• Study Type: interventional
• Target: 202
• Locations: 1 country
• Sites: 5

Brief 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

Keywords

persisting; chronic; low back pain; MRI spectroscopy; multidisciplinary rehabilitation; lumbar fusion surgery; lumbar interbody fusion; TLIF; rehabilitation; ALIF; LIFEHAB

Outcome Measures

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.

  At one-year follow-up

Secondary Outcomes (25)

• Oswestry Disability Index (ODI): Dichotomized

  At one-year follow-up

• Oswestry Disability Index (ODI): Continuous

  At one-year follow-up

• Numeric Rating Scale back pain (NRS back pain)

  At one-year follow-up

• Numeric Rating Scale leg pain (NRS leg pain)

  At one-year follow-up

• Global perceived effect (GPE)

  At one-year follow-up

Study Arms (2)

Lumbar Interbody Fusion (LIF)

EXPERIMENTAL

Per center standard, the LIF procedure is done in one or two levels between the second lumbar vertebra and sacrum, as a transforaminal lumbar interbody fusion (TLIF) or anterior lumbar interbody fusion (ALIF). Stabilization with screws is mandatory. TLIF employs bilateral pedicle screws. ALIF uses either pedicle or intra-device screws. At least one surgeon must be proficient in both procedure and implants. TLIF requires visual aids (microscope/magnifying glasses) for precise disc preparation. In the TLIF procedure, surgeons will maximize bone implantation into the disc space, anteriorly, posteriorly, or both. If the disc space is too narrow for an interbody device, autologous bone grafting into the disc space (local, spongious, or both) with posterior pedicle screw fixation is accepted. Optional posterolateral autologous bone grafting is allowed, but no substitutes or osteoinductive proteins (e.g., BMP). Surgical drain is optional.

Procedure: Lumbar Interbody Fusion

Multidisciplinary Rehabilitation

ACTIVE COMPARATOR

Rehabilitation, guided by a team of experienced specialists in physical medicine and rehabilitation and physiotherapists trained in cognitive therapy, will direct the multidisciplinary treatment. Patients receive 2.5-5 hour sessions 2-4 days weekly over 3-5 weeks. Standardization is maintained through pre-study training for providers, including seminars, podcasts, videos, and lectures. Individual screenings start the process, leading to focused discussions on thoughts, feelings, behaviour, and physical symptoms. A plan for the rehabilitation process with clearly defined individual goals will be worked out and revised every week. The three components described within the framework of cognitive functional therapy will be a template for the implementation of the functional and physical rehabilitation, involving pain understanding, exposure with control, and lifestyle changes like physical activity, sleep, diet, stress management, and social engagement.

Behavioral: Multidisciplinary rehabilitation

Interventions

Lumbar Interbody Fusion PROCEDURE

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

Lumbar Interbody Fusion (LIF)

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.

Multidisciplinary Rehabilitation

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify 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
• 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)

Sponsors & Collaborators

• Oslo University Hospital: lead
• University Hospital, Akershus: collaborator
• Haukeland University Hospital: collaborator
• Vestre Viken Hospital Trust: collaborator
• St. Olavs Hospital: collaborator
• Unicare: collaborator

Study Sites (5)

Vestre Viken Hospital

Drammen, Norway

NOT YET RECRUITING

Haukeland University Hospital

Hagavik, Norway

RECRUITING

Akershus University Hospital

Lørenskog, Norway

RECRUITING

Oslo University Hospital

Oslo, Norway

RECRUITING

St. Olavs Hospital

Trondheim, Norway

RECRUITING

Related Publications (19)

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  PMID: 31619437 BACKGROUND

• Gilbert HTJ, Hodson N, Baird P, Richardson SM, Hoyland JA. Acidic pH promotes intervertebral disc degeneration: Acid-sensing ion channel -3 as a potential therapeutic target. Sci Rep. 2016 Nov 17;6:37360. doi: 10.1038/srep37360.

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• Weber KT, Alipui DO, Sison CP, Bloom O, Quraishi S, Overby MC, Levine M, Chahine NO. Serum levels of the proinflammatory cytokine interleukin-6 vary based on diagnoses in individuals with lumbar intervertebral disc diseases. Arthritis Res Ther. 2016 Jan 7;18:3. doi: 10.1186/s13075-015-0887-8.

  PMID: 26743937 BACKGROUND

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  PMID: 27073460 BACKGROUND

• Hiyama A, Suyama K, Sakai D, Tanaka M, Watanabe M. Correlational analysis of chemokine and inflammatory cytokine expression in the intervertebral disc and blood in patients with lumbar disc disease. J Orthop Res. 2022 May;40(5):1213-1222. doi: 10.1002/jor.25136. Epub 2021 Jul 11.

  PMID: 34191345 BACKGROUND

• Gornet MG, Peacock J, Claude J, Schranck FW, Copay AG, Eastlack RK, Benz R, Olshen A, Lotz JC. Magnetic resonance spectroscopy (MRS) can identify painful lumbar discs and may facilitate improved clinical outcomes of lumbar surgeries for discogenic pain. Eur Spine J. 2019 Apr;28(4):674-687. doi: 10.1007/s00586-018-05873-3. Epub 2019 Jan 4.

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• Brox JI, Nygaard OP, Holm I, Keller A, Ingebrigtsen T, Reikeras O. Four-year follow-up of surgical versus non-surgical therapy for chronic low back pain. Ann Rheum Dis. 2010 Sep;69(9):1643-8. doi: 10.1136/ard.2009.108902. Epub 2009 Jul 26.

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• Brox JI, Reikeras O, Nygaard O, Sorensen R, Indahl A, Holm I, Keller A, Ingebrigtsen T, Grundnes O, Lange JE, Friis A. Lumbar instrumented fusion compared with cognitive intervention and exercises in patients with chronic back pain after previous surgery for disc herniation: a prospective randomized controlled study. Pain. 2006 May;122(1-2):145-55. doi: 10.1016/j.pain.2006.01.027. Epub 2006 Mar 20.

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MeSH Terms

Conditions

Bronchiolitis Obliterans Syndrome; Low Back Pain

Condition Hierarchy (Ancestors)

Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System Diseases; Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Christian Hellum, PhD

  Oslo University Hospital, Division of Orthopedic Surgery, OUS Ullevål

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sverre Mjønes, MD

CONTACT

+4767960000; svemjo@ahus.no

Kjersti Storheim, PhD

CONTACT

+4722117740; kjersti.storheim@ous-research.no

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcomes assessors will not have access to information about participants' allocated treatment groups (lumbar interbody fusion or multidisciplinary rehabilitation)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior researcher, professor

Study Record Dates

• First Submitted: November 22, 2023
• First Posted: December 13, 2023
• Study Start: April 15, 2024
• Primary Completion (Estimated): October 1, 2030
• Study Completion (Estimated): December 1, 2030
• Last Updated: March 17, 2026

Record last verified: 2026-03

Locations

NO (5)