Active — Not RecruitingNot Applicable

The NORDSTEN Studies/ The Spinal Stenosis Study

Norway465 participantsStarted 2013-11

Plain-language summary

Lumbar Spinal Stenosis (LSS) is a clinical entity were narrowing of the spinal canal gives a compression of the the neural and vascular structures in the spinal canal. This often gives neurogenic claudication and sometimes severe Low Back Pain (LBP). Surgery for LSS is today the most often performed procedure in the adult lumbar spine. Beneficial effect of surgical treatment is well documented by several clinical trials, and a Cochrane review article from 2005 concludes that surgical treatment is superior to non-surgical treatment. The surgical solution is to decompress the stenotic part of the lumbar spine. There is no consensus in the literature of which surgical method that gives best long term clinical results. The investigators are therefore planning a Randomized Controlled Trial, where they will compare clinical and radiological results of three different surgical methods for LSS. The main outcome of this study is to answer which surgical method that gives the best long term clinical results. And, secondary outcome is to find out how much increase of the Dural Sac Cross Sectional Area is needed to give a long time relief of the patients' symptoms.

Who can participate

Age range18 Years – 80 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * have clinical symptoms of spinal stenosis as neurogenic claudication or radiating pain into the bilaterally to the lower limbs, not responding to at least 3 months of conservative treatment. * Radiological findings corresponding to the clinical symptoms of LSS. Central -stenosis, or lateral recess-stenosis. * be able to give informed consent and to answer the questionnaires. * over 18 years of age-have -not responding to at least 3 months of non-surgical treatment. * be able to understand Norwegian language, spoken and in writing Exclusion Criteria: * have a degenerative lumbar spondylolisthesis, with a slip ≥ 3 mm verified on standing plain x-rays in lateral view. * are not willing to give written consent. * have former surgery in the level of stenosis. * fracture, or former fusion of the thoracolumbal region. * cauda equina syndrome (bowel or bladder dysfunction) or fixed complete motor deficit. * are ASA- classified 4 or 5. * are older than 80 years * have a lumbosacral scoliosis more than 20 degrees verified on AP-view * have distinct symptoms in one or both of their legs due to other diseases, e.g. polyneuropaty, vascular claudication or osteoarthtris. * LSS in 4 or more levels. * not able to comply fully with the protocol, including treatment, follow-up or study procedures (psychosocially, mentally and physical). * the patient is participating in another clinical trial that may interfere with this trial

What they're measuring

Oswestry Disability Index

Timeframe: 2, 5 and 10 years after surgery

Trial details

NCT IDNCT02007083

SponsorHaukeland University Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-10