Back pain showdown: surgery or rehab – new trial seeks answers
NCT ID NCT06169488
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times
Summary
This study compares two treatments for chronic low back pain lasting over a year: lumbar fusion surgery and a structured rehab program. About 202 adults aged 20-65 will be randomly assigned to one of the two. The goal is to see if surgery reduces disability more than rehab over time.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Lumbar interbody fusion surgery or multidisciplinary rehabilitation
- What this could lead to
- If it works, this could show that surgery is more effective than rehab for reducing disability from chronic low back pain.
- What could go wrong
- This is a single trial with 202 participants, and results may not apply to everyone. Surgery carries risks like infection or nerve damage, and rehab may not help all patients.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 202 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2024
- Expected to finish
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Dec 2030
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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20 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
5 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Akershus University Hospital
RECRUITINGLørenskog, Norway
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Haukeland University Hospital
RECRUITINGHagavik, Norway
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Oslo University Hospital
RECRUITINGOslo, Norway
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St. Olavs Hospital
RECRUITINGTrondheim, Norway
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Vestre Viken Hospital
NOT_YET_RECRUITINGDrammen, Norway
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