BACKGROUND: Neurogenic claudication due to lumbar spinal stenosis is a common problem that can be caused by many factors including hypertrophic ligamentum flavum, facet hypertrophy, and disc protrusion. When standard medical therapies such as pain medication, epidural steroid injections, and physical therapy fail, or when the patient is unwilling, unable, or not severe enough to advance to more invasive surgical procedures, both physicians and patients are often left with a treatment dilemma. Patients in this study were treated with mild, an ultra-minimally invasive lumbar decompression procedure using a dorsal approach. The mild procedure is performed under fluoroscopic imaging to resect bone adjacent to, and achieve partial resection of, the hypertrophic ligamentum flavum with minimal disruption of surrounding muscular and skeletal structure.
OBJECTIVE: To assess the clinical application and patient safety and functional outcomes of the mild lumbar decompression procedure in the treatment of symptomatic central canal spinal stenosis.
STUDY DESIGN: Multi-center, non-blinded, prospective clinical study.
SETTING: Fourteen US spine specialist practices.
METHODS: Between July 2008 and January 2010, 78 patients were enrolled in the MiDAS I Study and treated with the mild procedure for lumbar decompression. Of these patients, 6-week follow-up was available for 75 patients.
OUTCOME ASSESSMENT: Visual Analog Score (VAS), Oswestry Disability Index (ODI), Zurich Claudication Questionnaire (ZCQ), and SF-12v2 Health Survey. Outcomes were assessed at baseline and 6 weeks post-treatment.
RESULTS: There were no major device or procedure-related complications reported in this patient cohort. At 6 weeks, the MiDAS I Study showed statistically and clinically significant reduction of pain as measured by VAS, ZCQ, and SF-12v2. In addition, improvement in physical function and mobility as measured by ODI, ZCQ, and SF-12v2 was statistically and clinically significant in this study.
LIMITATIONS: This is a preliminary report encompassing 6-week follow-up. There was no control group.
CONCLUSIONS: In this 75-patient series, and in keeping with a previously published 90-patient safety cohort, the mild procedure proved to be safe. Further, based on near-term follow-up, the mild procedure demonstrated efficacy in improving mobility and reducing pain associated with lumbar spinal canal stenosis.
BACKGROUND: Interspinous stand-alone implants are inserted without open decompression to treat symptomatic lumbar spinal stenosis (LSS). The insertion procedure is technically simple, low-risk, and quick. However, the question remains whether the resulting clinical outcomes compare with those of microsurgical decompression, the gold standard.
MATERIAL AND METHODS: This prospective, comparative study included all patients (n=36) with neurogenic intermittent claudication (NIC) secondary to LSS with symptoms improving in forward flexion treated operatively with either interspinous stand-alone spacer insertion (Aperius (®); Medtronic, Tolochenaz, Switzerland) (group 1) or microsurgical bilateral operative decompression (group 2) between February 2007 and November 2008. Data (patient data, operative data, COMI, SF-36 PCS and MCS, ODI, and walking tolerance) were collected preoperatively as well as at 6 weeks, at 3, 6, and 9 months, and at one year follow-up (FU). All patients had complete FU over 1 year.
RESULTS: Compared to preoperative measurements, surgery led to improvements of all parameters in the entire collective as well as both individual groups. There were no statistically relevant differences between the 2 groups over the entire course of FU. However, improvements in the ODI and SF-36 MCS were not significant in group 1, in contrast to those of group 2. Also, although in group 1 the improvements in leg pain (VAS leg) were still significant (p<0.05) at 6 months, this was no longer the case at 1 year FU. In group 1 at 1 year FU an increase in leg pain was observed, while in group 2, minimal improvements continued. Walking tolerance was significantly improved at all FU times compared to preoperatively, regardless of group (p<0.01). At no time there was a significant difference between the groups. In group 1, admission and operative times were shorter and blood loss decreased. The complication rate was 0% in group 1 and 20% in group 2, however reoperation was required by 27.3% of group 1 patients and 0% of group 2.
CONCLUSION: Implantation of an interspinous stand-alone spacer yields clinical success comparable to open decompression, at least within the first year of FU. The 1-year conversion rate of 27.3% is, however, decidedly too high.
OBJECTIVE: To assess the effectiveness of therapeutic exercises alone and in combination with a single physical agent - ultrasound - in patients with lumbar spinal stenosis. DESIGN: Randomized, prospective, controlled trial. SETTING: Department of Physical Medicine and Rehabilitation, University Hospital. SUBJECTS: Forty-five patients presenting with symptoms of neurological claudication and magnetic resonance image-proven lumbar spinal stenosis were assigned to one of three groups: ultrasound plus exercise group (group 1, n =15), sham ultrasound plus exercise group (group 2, n= 15) and no exercise - no treatment group (control group, n = 15). INTERVENTIONS: Stretching and strengthening exercises for lumbar, abdominal, leg muscles as well as low-intensity cycling exercises were given as therapeutic exercises. Ultrasound was applied with 1 mHz, 1.5 W/cm(2) intensity, in continuous mode on the back muscle for 10 minutes in group 1 while ultrasound on/off mode was applied in group 2. MAIN OUTCOME MEASURES: Before and after a three-week period, all subjects were evaluated by pain, disability, functional capacity and consumption of analgesic. RESULTS: Thirty-two of the participants were women and 13 were men, with an average age of 53.2 +/- 12.68 years (range 25-82 years). After a three-week treatment period, leg pain decreased in group 1 (-1.47 +/- 3.02) and group 2 (-2.47 +/- 3.75) compared with the control group (P<0.05). Disability score decreased in group 1 (-3.94 +/- 7.20) and group 2 (-7.80 +/- 10.26) compared with control group (P<0.05). We did not find any statistically significant difference between groups 1 and 2 (P>0.05). The amount of analgesic consumption is significantly less in the group with ultrasound application compared to that in the control group (P<0.05). CONCLUSION: The results of our study suggest that therapeutic exercises are effective for pain and disability in patients with lumbar spinal stenosis and that addition of ultrasound to exercise therapy lowers the analgesic intake substantially.
OBJECT: This study was designed to evaluate the efficacy of decompressive surgery for degenerative lumbar spinal stenosis (LSS) on a functional and clinical basis.
METHODS: A prospective analysis and follow-up of 125 consecutive patients with degenerative LSS between 2000 and 2006 were performed. All patients underwent surgery for lumbar stenosis. Functional evaluations of the patients were performed using a treadmill, the visual analog scale, and the Oswestry Disability Questionnaire (ODQ). These parameters were recorded before surgery and the 3rd month and 1st and 2nd years after treatment. The first symptom time (FST), maximal walking duration (MWD), and thecal sac cross-sectional area (CSA) before and after surgery were also recorded. Statistical relations between variables were calculated.
RESULTS: As patient ages increased, the CSA of the thecal sac decreased. Decompressive surgery reached the target according to the difference between the preoperative and postoperative thecal sac CSA. A correlation between the CSA of the thecal sac and FST, and between the CSA of the thecal sac and MWD could not be established. There was a significant correlation between the FST and MWD, and a negative correlation could be established between the MWD and the ODQ score. Surgery led to significant decreases in the ODQ score. Maximal improvement was observed in the 3rd month after decompressive surgery.
CONCLUSIONS: The treatment for LSS should be decided using functional criteria; radiological criteria may not correlate with the severity of the disease. Improvements following lumbar decompression surgery continued within 1 year of treatment according to the ODQ and did not change significantly thereafter.
BACKGROUND: Surgery for spinal stenosis is widely performed, but its effectiveness as compared with nonsurgical treatment has not been shown in controlled trials.
METHODS: Surgical candidates with a history of at least 12 weeks of symptoms and spinal stenosis without spondylolisthesis (as confirmed on imaging) were enrolled in either a randomized cohort or an observational cohort at 13 U.S. spine clinics. Treatment was decompressive surgery or usual nonsurgical care. The primary outcomes were measures of bodily pain and physical function on the Medical Outcomes Study 36-item Short-Form General Health Survey (SF-36) and the modified Oswestry Disability Index at 6 weeks, 3 months, 6 months, and 1 and 2 years.
RESULTS: A total of 289 patients were enrolled in the randomized cohort, and 365 patients were enrolled in the observational cohort. At 2 years, 67% of patients who were randomly assigned to surgery had undergone surgery, whereas 43% of those who were randomly assigned to receive nonsurgical care had also undergone surgery. Despite the high level of nonadherence, the intention-to-treat analysis of the randomized cohort showed a significant treatment effect favoring surgery on the SF-36 scale for bodily pain, with a mean difference in change from baseline of 7.8 (95% confidence interval, 1.5 to 14.1); however, there was no significant difference in scores on physical function or on the Oswestry Disability Index. The as-treated analysis, which combined both cohorts and was adjusted for potential confounders, showed a significant advantage for surgery by 3 months for all primary outcomes; these changes remained significant at 2 years.
CONCLUSIONS: In the combined as-treated analysis, patients who underwent surgery showed significantly more improvement in all primary outcomes than did patients who were treated nonsurgically. (ClinicalTrials.gov number, NCT00000411 [ClinicalTrials.gov].).
STUDY DESIGN: A randomized controlled trial.
OBJECTIVES: To assess the effectiveness of decompressive surgery as compared with nonoperative measures in the treatment of patients with lumbar spinal stenosis.
SUMMARY OF BACKGROUND DATA: No previous randomized trial has assessed the effectiveness of surgery in comparison with conservative treatment for spinal stenosis.
METHODS: 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.
RESULTS: 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.
CONCLUSIONS: 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.
For patients with clinical and radiographic lumbar spinal stenosis, is surgery or continued nonsurgical treatment a better option for improvements in baseline disability scores; and what proportion of patients treated surgically and nonsurgically get better, worse, or remain the same with time? We prospectively evaluated 125 consecutive patients for this non-randomized cohort study. Of the patients choosing surgery, 54 underwent decompression only and 42 had decompression and fusion for preexisting spondylolisthesis; twenty-nine patients declined surgery. At 2 years followup, the average improvements in Roland-Morris questionnaire score in the decompression only, decompression with fusion, and nonsurgical groups were 6.9, 6.1, and 1.2, respectively. The percentages of patients who were better, worse, or the same were similar for those who had decompression only (63.3%, 4.1%, and 32.7%, respectively) and decompression with fusion (61.5%, 2.6%, and 35.9%, respectively) but different from those treated without surgery (25.0%, 12.5%, and 62.5%, respectively). We observed no occurrences of cauda equina syndrome or severe neurologic dysfunction in any of the groups after 2 years. A majority of patients declining surgery had persistent symptoms. The majority of patients who choose surgery will be improved but will have residual symptoms and therefore should be counseled about realistic expectations.
QUESTION: Is 6 weeks of treadmill walking with body weight support more effective than cycling in people with lumbar spinal stenosis when added to an exercise program?
DESIGN: Randomised controlled trial with concealed allocation, assessor blinding, and intention-to-treat analysis.
PARTICIPANTS: Sixty-eight patients aged 58 (SD 8) with symptoms of lumbar spinal stenosis for 12 weeks (SD 49).
INTERVENTION: Participants performed either treadmill with body weight support or cycling, twice weekly, for 6 weeks. Both groups also received an exercise program consisting of heat, lumbar traction, and flexion exercises.
OUTCOME MEASURES: The primary outcome was disability measured using the modified Oswestry Disability Index. Secondary outcomes were disability, measured using the Roland-Morris Disability Questionnaire, pain severity, and patient perceived benefit. Measures were collected midway through intervention at 3 weeks and after intervention at 6 weeks.
RESULTS: There was no difference between the groups in reduction in disability or pain over the 6-week intervention period. The between-group difference in the modified Oswestry Disability Index was 3.2 points (95% CI -3.1 to 7.7) at 6 weeks, and in pain severity was 2 mm on a 100 visual analogue scale (95% CI -5 to 10). Furthermore, the wide confidence intervals associated with estimates of patient benefit are consistent with no difference between the two groups. However, both groups did improve.
CONCLUSION: Treadmill with body weight support and cycling may be equally effective in the conservative management of people with lumbar spinal stenosis. However, the improvement observed in both groups was probably a combination of the intervention and the natural course of recovery of lumbar spinal stenosis.
Neurogenic claudication due to lumbar spinal stenosis is a common problem that can be caused by many factors including hypertrophic ligamentum flavum, facet hypertrophy, and disc protrusion. When standard medical therapies such as pain medication, epidural steroid injections, and physical therapy fail, or when the patient is unwilling, unable, or not severe enough to advance to more invasive surgical procedures, both physicians and patients are often left with a treatment dilemma. Patients in this study were treated with mild, an ultra-minimally invasive lumbar decompression procedure using a dorsal approach. The mild procedure is performed under fluoroscopic imaging to resect bone adjacent to, and achieve partial resection of, the hypertrophic ligamentum flavum with minimal disruption of surrounding muscular and skeletal structure.
OBJECTIVE:
To assess the clinical application and patient safety and functional outcomes of the mild lumbar decompression procedure in the treatment of symptomatic central canal spinal stenosis.
Between July 2008 and January 2010, 78 patients were enrolled in the MiDAS I Study and treated with the mild procedure for lumbar decompression. Of these patients, 6-week follow-up was available for 75 patients.
OUTCOME ASSESSMENT:
Visual Analog Score (VAS), Oswestry Disability Index (ODI), Zurich Claudication Questionnaire (ZCQ), and SF-12v2 Health Survey. Outcomes were assessed at baseline and 6 weeks post-treatment.
RESULTS:
There were no major device or procedure-related complications reported in this patient cohort. At 6 weeks, the MiDAS I Study showed statistically and clinically significant reduction of pain as measured by VAS, ZCQ, and SF-12v2. In addition, improvement in physical function and mobility as measured by ODI, ZCQ, and SF-12v2 was statistically and clinically significant in this study.
LIMITATIONS:
This is a preliminary report encompassing 6-week follow-up. There was no control group.
CONCLUSIONS:
In this 75-patient series, and in keeping with a previously published 90-patient safety cohort, the mild procedure proved to be safe. Further, based on near-term follow-up, the mild procedure demonstrated efficacy in improving mobility and reducing pain associated with lumbar spinal canal stenosis.
