• Pain Pract · Jun 2012

    Randomized Controlled Trial Comparative Study

    A double-blind, randomized, prospective study of epidural steroid injection vs. the mild® procedure in patients with symptomatic lumbar spinal stenosis.

    • Lora L Brown.
    • Coastal Orthopedics and Sports Medicine, Bradenton, FL, USA. painmedicinedoctor@hotmail.com
    • Pain Pract. 2012 Jun 1;12(5):333-41.

    BackgroundEpidural steroid injections (ESIs) are commonly used to treat low back pain, including symptomatic lumbar spinal stenosis (LSS). Reports on LSS treatment with ESIs have not differentiated between neurogenic claudication, which is believed to result from nerve root compression, and lumbar radicular pain, thought to be caused by inflammation. While there is overlap between these groups, the clinical relevance of ESI treatment cannot be generalized between these 2 distinct diseases with completely different pathophysiological causes.MethodsThis was a double-blind, randomized, prospective study of ESI vs. the mild procedure in patients with symptomatic LSS, conducted at a single pain management center. Patient reported outcome measures included Visual Analog Scale, Oswestry Disability Index, and Zurich Claudication Questionnaire (ZCQ) patient satisfaction.ResultsThirty-eight patients were randomized into 2 treatment groups, 21 in mild and 17 in ESI. At 6- and 12-week follow-up, patients treated with mild reported significantly greater pain decrease over time (P < 0.0001), and significantly greater functional mobility improvement over time (P < 0.0018) than ESI patients. At week 6, mild ZCQ patient satisfaction score of 2.2 indicated a higher level of satisfaction than for ESI with a score of 2.8. In addition, 12-week ZCQ satisfaction score was 1.8, demonstrating sustained near-term satisfaction in the mild group. No major mild or ESI device or procedure-related complications were reported.ConclusionsThis study demonstrated that in LSS patients suffering with neurogenic claudication, mild provides statistically significantly better pain reduction and improved functional mobility vs. treatment with ESI.© 2012 The Authors. Pain Practice © 2012 World Institute of Pain.

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