Comparing lumbar fusion surgery to rehabilitation for chronic low back pain

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This trial aims to evaluate the effectiveness of lumbar interbody fusion surgery versus a multidisciplinary rehabilitation program for individuals aged 20-65 suffering from chronic low back pain lasting over a year. Participants will be randomly assigned to either treatment group and will undergo various assessments, including radiologic examinations and activity monitoring. The study seeks to determine which approach provides better relief from persistent low back pain and improves patient outcomes.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. 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
2. 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
3. Back-related disability: ODI 30 - 60 points at baseline
4. Back pain \> leg pain
5. 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

Exclusion Criteria:

1. Multilevel disc degeneration requiring intervention beyond two levels
2. Spondylolysis or lytic spondylolisthesis
3. History of previous spondylodiscitis
4. Previous lumbar fusion surgery
5. Scoliosis \>20 degrees
6. Signs of a vertebral fracture at the planned level of fusion or its adjacent levels
7. Active smokers
8. 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)
9. Significant nerve root compression assessed by MRI and clinical examination
10. BMI \> 40
11. Not understanding the Norwegian language.
12. Generalized myalgia, including history or signs of fibromyalgia and myalgic encephalitis
13. Contraindications to MRI (e.g., cardiac pacemaker electrodes, metal implants in the eye or brain, claustrophobia).
14. Active cancer
15. Disabling chronic neurological disease (e.g., Parkinson's disease, ALS, MS)
16. Disabling osteoarthritis of the hip or knee (Kellgren \& Lawrence grade III or higher)
17. Daily use of morphine equivalents ≥ 60mg or regular use of morphine-containing pain patches
18. Decline specific treatment arm

Where it's running

• Haukeland University Hospital
  Hagavik, Norway Recruiting
• Akershus University Hospital
  Lørenskog, Norway Recruiting
• Oslo University Hospital
  Oslo, Norway Recruiting
• St. Olavs Hospital
  Trondheim, Norway Recruiting
• Vestre Viken Hospital
  Drammen, Norway Not yet recruiting

Study contacts

• Principal investigator: Christian Hellum, PhD — Oslo University Hospital, Division of Orthopedic Surgery, OUS Ullevål
• Study coordinator: Sverre Mjønes, MD
• Email: svemjo@ahus.no
• Phone: +4767960000

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.