Surgical or nonoperative treatment for lumbar spinal stenosis? A randomized controlled trial.
ABSTRACT A randomized controlled trial.
To assess the effectiveness of decompressive surgery as compared with nonoperative measures in the treatment of patients with lumbar spinal stenosis.
No previous randomized trial has assessed the effectiveness of surgery in comparison with conservative treatment for spinal stenosis.
Four university hospitals agreed on the classification of the disease, inclusion and exclusion criteria, radiographic routines, surgical principles, nonoperative treatment options, and follow-up protocols. A total of 94 patients were randomized into a surgical or nonoperative treatment group: 50 and 44 patients, respectively. Surgery comprised undercutting laminectomy of the stenotic segments in 10 patients augmented with transpedicular fusion. The primary outcome was based on assessment of functional disability using the Oswestry Disability Index (scale, 0-100). Data on the intensity of leg and back pain (scales, 0-10), as well as self-reported and measured walking ability were compiled at randomization and at follow-up examinations at 6, 12, and 24 months.
Both treatment groups showed improvement during follow-up. At 1 year, the mean difference in favor of surgery was 11.3 in disability (95% confidence interval [CI], 4.3-18.4), 1.7 in leg pain (95% CI, 0.4-3.0), and 2.3(95% CI, 1.1-3.6) in back pain. At the 2-year follow-up, the mean differences were slightly less: 7.8 in disability (95% CI, 0.8-14.9) 1.5 in leg pain (95% CI, 0.3-2.8), and 2.1 in back pain (95% CI, 1.0-3.3). Walking ability, either reported or measured, did not differ between the two treatment groups.
Although patients improved over the 2-year follow-up regardless of initial treatment, those undergoing decompressive surgery reported greater improvement regarding leg pain, back pain, and overall disability. The relative benefit of initial surgical treatment diminished over time, but outcomes of surgery remained favorable at 2 years. Longer follow-up is needed to determine if these differences persist.
SourceAvailable from: PubMed Central[Show abstract] [Hide abstract]
ABSTRACT: To evaluate the effectiveness of the In- space (Synthes, Umkirch, Germany) and the correlation between radiographic parameters and clinical outcome in patients with lumbar spinal canal stenosis (LSS). Between June 2009 and May 2013, 56 patients with LSS underwent In-space by one senior surgeon. All of the patients were evaluated both clinically and radiographic measurements before the procedure and each visit at the postoperative follow-up. Preoperative and postoperative X-ray imaging was performed before the procedure and at follow-up to assess the correlation with the clinical outcome. Radiological measurements and clinical outcomes were recorded to establish a relationship between the radiographic parameters and clinical outcome of this procedure. All patients had at least 2 years of follow-up. The mean VAS score of back pain decreased significantly (p < 0.05). Our data suggest that percutaneous interspinous devices are a good alternative to treat LSS. The device offers significant decrease in back pain, leg pain and ODI score with 2-year lasting relief from symptoms. The increased intervertebral foramenal space explains the improvement of leg pain, but the mechanism of back pain relief remains unclear. A very weak correlation between the radiographic changes and improvement of pain was found.
[Show abstract] [Hide abstract]
ABSTRACT: Purpose: The device for intervertebral assisted motion (DIAMTM) is an interspinous (ISP) implant used to augment surgical decompression of lumbar degenerative conditions: Lumbar spinal stenosis [LSS; foraminal (FS) or central canal (CS)], herniated and degenerated disc disease, facet joint pain syndrome (FJPS) and minor degenerative spondylolisthesis (DS). Limited evidence guides its use in defined clinical indications, while few studies demonstrate effect according to clinically meaningful change (MCID). This prospective longitudinal study examined the efficacy of DIAM-augmented decompression surgery in the broad application of a single-center clinical reality. Methods: Eighty-one consecutive cases [37F, 44M; 52 years (SD 13)] were examined for two years after DIAM-augmented decompression surgery. Patient-reported pain [back and leg; visual analogue scale (VAS)], function [Oswestry disability index (ODI)], and satisfaction (Likert scale) were serially examined and referenced to contemporary MCID thresholds. Subjects were classified into anatomical and diagnostic categories and analyzed according to subgroups to better inform clinical pathways. Serial change was assessed with Scheffe post-hoc test; change scores with unpaired t-tests and descriptive statistics (p < 0:05). Results: Subjects reported 20.4% (SD 29.5; p < 0:0001) mean improvement in back pain, 20.3% (SD 30.6; p < 0:0001) in leg pain, and 15.1% (SD 20.8; p < 0:0001) in function at two years postoperatively. Greatest improvement was seen at six weeks for back pain (by 30.5%; p < 0:0001) and leg pain (by 29.4%; p < 0:0001) and three months for function (by 18.7%; p < 0:0001). Leg pain deteriorated between six weeks and 18 months (p < 0:05). There were more responders at one compared to two years after surgery. FS cases showed superior improvement compared to DS subjects (p < 0:05). Cases receiving multiple adjunctive surgical decompressions in addition to their DIAM had superior improvement than those receiving a single procedure (p < 0:05). Conclusions: Clinical improvement in back pain, leg pain and function were achieved to two years in a single-center cohort of 81 cases with lumbar degenerative disease who received DIAM-augmented decompression surgery. Subsets of the sample had a superior sustained response including foraminal/lateral recess stenosis patients and cases treated with > 1 adjunctive decompression techniques. The need for assessing homogeneous cohorts in future studies is emphasized.Journal of Musculoskeletal Research 07/2012; 15(3):1250018. DOI:10.1142/S0218957712500182
[Show abstract] [Hide abstract]
ABSTRACT: Purpose To compare patient outcomes and complication rates after different decompression techniques or instrumented fusion (IF) in lumbar spinal stenosis (LSS). Methods The multicentre study was based on Spine Tango data. Inclusion criteria were LSS with a posterior decompression and pre- and postoperative COMI assessment between 3 and 24 months. 1,176 cases were assigned to four groups: (1) laminotomy (n = 642), (2) hemilaminectomy (n = 196), (3) laminectomy (n = 230) and (4) laminectomy combined with an IF (n = 108). Clinical outcomes were achievement of minimum relevant change in COMI back and leg pain and COMI score (2.2 points), surgical and general complications, measures taken due to complications, and reintervention on the index level based on patient information. The inverse propensity score weighting method was used for adjustment. Results Laminotomy, hemilaminectomy and laminectomy were significantly less beneficial than laminectomy in combination with IF regarding leg pain (ORs with 95 % CI 0.52, 0.34–0.81; 0.25, 0.15–0.41; 0.44, 0.27–0.72, respectively) and COMI score improvement (ORs with 95 % CI 0.51, 0.33–0.81; 0.30, 0.18–0.51; 0.48, 0.29–0.79, respectively). However, the sole decompressions caused significantly fewer surgical (ORs with 95 % CI 0.42, 0.26–0.69; 0.33, 0.17–0.63; 0.39, 0.21–0.71, respectively) and general complications (ORs with 95 % CI 0.11, 0.04–0.29; 0.03, 0.003–0.41; 0.25, 0.09–0.71, respectively) than laminectomy in combination with IF. Accordingly, the likelihood of required measures was also significantly lower after laminotomy (OR 0.28, 95 % CI 0.17–0.46), hemilaminectomy (OR 0.28, 95 % CI 0.15–0.53) and after laminectomy (OR 0.39, 95 % CI 0.22–0.68) in comparison with laminectomy with IF. The likelihood of a reintervention was not significantly different between the treatment groups. Discussion As already demonstrated in the literature, decompression in patients with LSS is a very effective treatment. Despite better patient outcomes after laminectomy in combination with IF, caution is advised due to higher rates of surgical and general complications and consequent required measures. Based on the current study, laminotomy or laminectomy, rather than hemilaminectomy, is recommendable for minimum relevant pain relief.European Spine Journal 01/2014; DOI:10.1007/s00586-014-3349-0 · 2.47 Impact Factor