Education (Grade I).

Many professionals in the practice of medicine consider patient education to be paramount in the success of any recommended therapy. Recent spinal literature has focused on a variety of both nonsurgical and surgical therapies. Although some randomized trials evaluate the effect of educational programs as a therapeutic adjunct in the surgical treatment of patients undergoing lumbar disc decompression surgery, other trials applying educational strategies have grouped heterogeneous populations of patients.^2,3 A relative paucity in recent Level I and II literature evaluating the effects of educational therapy or programs specifically in the treatment of lumbar spinal stenosis exists. Deyo and investigators⁴ evaluated the effect of an interactive video program in the decision-making process for patients considering surgical treatment for their lumbar spinal conditions. This prospective, randomized clinical trial at two centers enrolled a heterogeneous population of patients (171 patients with herniated discs, 110 patients with lumbar spinal stenosis, 112 with other diseases). The authors observed a greater rate of surgery in the video group (39% video and booklet vs. 29% booklet alone). However, this was not statistically significant (P = 0.34), and the authors indicated that the study was underpowered for their subgroup proportional comparisons in the patients with lumbar spinal stenosis (power analysis post hoc = 12%). The study did not observe a significant effect of the video program on symptomatic and functional results at 3 months and 1 year. In addition, there did not appear to be a significant effect on patient satisfaction with care or their satisfaction with the decision-making process comparing the two randomized groups. Overall study follow-up rate was 88% at 1 year. Compliance in the video program and booklet group was 97% for the video portion and 84% for the booklet portion, respectively, and 97% in the booklet alone group. In a follow-up study evaluating the knowledge gain as assessed by a pretreatment and post-treatment knowledge test, the combination of the interactive video with booklet produced greater knowledge gains than the book alone group in the subgroup of patients with the least knowledge at baseline.⁵

Medications (Grade I).

A wide gamut of oral medications is available for the potential treatment of symptomatic lumbar spinal stenosis. These include, among others, nonsteroidal agents, analgesics (narcotic and non-narcotic), and antineuritics (tricyclic antidepressants, anticonvulsants). Although there are many randomized studies of various medications for lower back disorders and low back pain, few have specifically focused on patients with stenosis. Of the few studies that have focused specifically on patients with lumbar stenosis, a couple of randomized studies on the evaluation of calcitonin treatment have been reported.^6–8 Eskola and colleagues⁶ performed a randomized, placebo-controlled, double-blind, crossover study in 40 patients with lumbar spinal stenosis with 1-year follow-up demonstrating that calcitonin had beneficial effects on patients’ symptoms without producing significant adverse effects.⁶ The investigators observed primarily an analgesic effect with some positive effect on walking distance, although the authors note that the treatment effect was poor in those patients with marked limitation in walking distance caused by neurogenic claudication. Podichetty and coauthors⁷ randomized 55 patients with clinical lumbar canal stenosis and pseudoclaudication and pain visual analog scale (VAS) index of greater than or equal to 6 to either placebo or intranasal calcitonin for 6 weeks followed by an open-label 6-week extension during which all patients received active drug. Calcitonin was administered by nasal spray (400 IU daily) at twice the clinical dose typically used for postmenopausal women with osteoporosis. The overall study dropout rate was 22% for reasons relating to study protocol deviations, adverse event reporting, or withdrawal because of lack of perceived efficacy. Rash, erythema, and burning of the face and neck regions severe enough to cause withdrawal from treatment occurred in two patients in the experimental group. At 6 weeks, there was no difference between the two groups in change in pain VAS when compared with baseline. No difference existed between groups in time from the onset of walking to the onset of pain. Patients in both treatment groups reported improvements to their overall walking distance. However, no difference was present between the study groups. There also did not appear to be a significant effect on patient-reported functional outcome measures. The authors conclude that nasal calcitonin is not superior to placebo, and they suggest that the drug does not appear to have a role in the nonoperative treatment of lumbar canal stenosis. The study authors evaluated efficacy primarily at 6 weeks. The open-label phase during the subsequent 6 weeks suggested a trend toward improvement in patients treated with salmon calcitonin during the second phase of the trial, particularly in pain scores and 36-Item Short Form Health Survey (SF-36) results. The authors note that it is possible that the beneficial effects of nasal calcitonin could require a longer preload of drug, and that efficacy may be achieved using a different treatment schedule. In addition, the authors also indicate that the mean walking distance of patients in their study was in the more limited range where efficacy was also not demonstrated in the similar subpopulation of the study that Eskola and colleagues⁶ reported.

One of the more recent randomized studies specifically focusing on lumbar spinal stenosis patients evaluated the use of gabapentin, which has been used in the treatment of chronic neuropathic pain. Yaksi and coworkers⁹ randomized 55 patients with lumbar spinal stenosis and intermittent neurogenic claudication into 2 groups. Both randomized groups received physical therapy exercises, lumbosacral corset using a steel reinforced bracing design, and pharmacologic treatment with nonsteroidal anti-inflammatory drugs. The treatment group received in addition oral gaba-pentin administered at a dosage of 900 mg/day and increased weekly in increments of 300 mg up to a total maximal dosage of 2400 mg/day. Patients who experienced side effects (drowsiness and dizziness) were prescribed bed rest and increased oral fluid intake. Study end points to 4 months included objective assessments of walking distance, VAS scores, and proportional methods analysis of motor and sensory deficits within each group and at the end of treatment. At follow-up, both groups demonstrated improvement, with the gabapentin treatment group showing significantly better walking distance and improvements in pain scores and recovery of sensory deficit. Limitations of the study include the length of follow-up and the potential confounder of the placebo effect (Level II).

Therapeutic Exercises (Grade I).

Many randomized, controlled trials evaluating therapeutic or rehabilitative exercise programs in lumbar spinal disorders have often used a heterogenous population of patients with chronic low back pain. A small number of patients evaluated represent patients with spinal stenosis for which the severity and extent of neurologic leg symptomatology relative to back pain is poorly characterized. In addition, studies comparing therapeutic exercise with surgery have primarily evaluated fusion surgery as compared with nonsurgical treatment in the management of mechanical low back pain in lumbar spondylosis.^10–12 In lumbar spinal stenosis, some authors have proposed programs that use lumbar flexion exercises with the avoidance of extension exercises because of the spinal canal and neuroforaminal narrowing produced by lumbar extension. General aerobic conditioning and aqua therapy have also been advised in the treatment of these patients. However, limited evidence is available that actually guides the recommendation of one program over another or evaluates the benefit of such programs over natural history alone. In one study by Whitman and colleagues,¹³ the authors performed a multicenter, randomized, controlled trial on 58 patients with lumbar spinal stenosis. Patients were randomized to one of two 6-week physical therapy programs. One program consisted of manual therapy, lumbar exercises, and body weight supported treadmill walking, whereas the other program consisted of ultrasound, lumbar flexion exercises, and treadmill walking. Patient-perceived recovery was the primary outcome with secondary measures including Oswestry Disability Index, a numeric pain rating, satisfaction, and the results of the treadmill test. Patients in both randomized groups demonstrated improvements to measured outcome parameters. Perceived recovery was greater for the program consisting of manual therapy, treadmill walking, and exercise (perceived recovery 2.6; confidence interval, 1.8–7.8). Considerations to the study results was follow-up to 1 year and that a subset of patients in each group received additional treatment during the study period consisting of epidural steroid injection, surgery, medications, and/or additional specialty physician consultations (Level II).