Study-protocol for a randomized controlled trial comparing clinical and radiological results after three different posterior decompression techniques for lumbar spinal stenosis: the Spinal Stenosis Trial (SST) (part of the NORDSTEN Study)

Abstract

BackgroundThere are several posterior decompression techniques for lumbar spinal stenosis (LSS). There is a trend towards performing less invasive surgical procedures, but no multicentre randomized controlled trials have evaluated the relative efficacy of these techniques at short and long-term.Method/designA multicentre randomized controlled trial [the Spinal Stenosis Trial (SST) (part of the NORDSTEN study)] including 465 patients aged 18–80 years with neurogenic claudication or radiating pain and MRI findings indicating lumbar spinal stenosis without spondylolisthesis is performed to compare three posterior decompression techniques: unilateral laminotomy with crossover, bilateral laminotomy and spinous process osteotomy. The primary outcome is change in Oswestry Disability Index (ODI 2 years postoperatively). Secondary outcomes are change in EQ-5D, Zurich Claudication Questionnaire, and Numeric Rating Scale for leg-pain and back-pain. Also recorded were Global Perceived Effect score, complications, length of hospital stay, reoperation rate 2 years postoperatively, difference in recurrence of symptoms or postoperative instability, and MRI change in the dural sac area. Further, a 5 and 10 years follow-up is planned with the same outcome measures.DiscussionNewer and less invasive techniques are increasingly favoured in surgery for LSS. This trial will compare the clinical and radiological results of three different techniques, and may contribute to better clinical decision making in the surgical treatment of LSS.Trial registrationClinicalTrials.gov reference: NCT02007083 (November 22, 2013).

Patients’ Perceptions Of Lumbar Spinal Stenosis And Experiences After Surgical Treatment

“…The patients described the pain intensity and how the pain brought limitations for meaningful activities and tasks. This is in accordance to earlier quantitative studies which document patients' recovery from pain as a result of operative treatment [7]. The current study illustrated the emotional consequences of the long lasting and strong pain.…”

“…Therefore the results can be transferred to other patients with same diagnosis, surgical treatment and health care options [12]. The results in this study are also supported by earlier research [7].…”

“…Five were women and five were men, aged 61 to 79 years. and quality of life, was constructed [7,12]. The transcription was done immediately after each interview.…”

“…Posterior decompression is a collective term for multiple posterior decompression techniques used to relieve the compression of the nerves in the spinal canal [7]. Using one of these different techniques, one creates better conditions for the nerve structures of the spinal cord.…”

Navigated minimally invasive unilateral laminotomy with crossover for intraoperative prediction of outcome in degenerative lumbar stenosis

“…Simple posterior decompression represents one the most used techniques for surgical treatment of degenerative lumbar spine stenosis. [ 1 2 3 4 5 6 7 8 9 10 11 12 13 14 ] Different surgical techniques have been described,[ 4 7 8 9 10 11 12 13 14 ] but a clear superiority of one technique over the others regarding pain and functional outcome has not been identified. [ 2 10 15 16 ]…”