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Pain Pract. 2023 Sep 3.
doi: 10.1111/papr.13293. Online ahead of print.
The MOTION study: Two-year results of a real-world randomized controlled trial of the mild® procedure for treatment of lumbar spinal stenosis
Timothy R Deer 1, Timothy B Chafin 2, Shrif J Costandi 3, Huaguang Qu 4, Christopher Kim 1, Navdeep Jassal 5, Kiran Patel 6, Aaron Calodney 7Affiliations expand
- PMID: 37661347
- DOI: 10.1111/papr.13293
Abstract
Objective: The MOTION study is designed to measure the impact of percutaneous image-guided lumbar decompression as a first-line therapy on patients otherwise receiving real-world conventional medical management for lumbar spinal stenosis with neurogenic claudication secondary to hypertrophic ligamentum flavum. This prospective, multicenter randomized controlled trial uses objective and patient-reported outcome measures to compare the combination of the mild® percutaneous treatment and nonsurgical conventional medical management (CMM) to CMM-Alone.Methods: Test group patients received the mild procedure after study enrollment. Test and control groups were allowed conventional conservative therapies and low-risk interventional therapies as recommended by their physicians. Subjective outcomes included the Oswestry Disability Index, Numeric Pain Rating Scale, and Zurich Claudication Questionnaire. Objective outcomes included a validated Walking Tolerance Test, the rate of subsequent lumbar spine interventions, and safety data.
Results: Two-year follow-up included 64 mild + CMM and 67 CMM-Alone patients. All outcome measures showed significant improvement from baseline for mild + CMM, whereas the majority of CMM-Alone patients had elected to receive mild treatment or other lumbar spine interventions by 2 years, precluding valid 2-year between-group comparisons. Neither group reported any device- or procedure-related adverse events.
Conclusions: The durability of mild + CMM for this patient population was demonstrated for all efficacy outcomes through 2 years. Improvements in walking time from baseline to 2 years for patients treated with mild + CMM were significant and substantial. The lack of reported device or procedure-related adverse events reinforces the strong safety profile of the mild procedure. These results provide support for early interventional treatment of symptomatic LSS with the mild procedure.
Keywords: mild; CMM; hypertrophic ligamentum flavum; low back pain; lumbar spinal stenosis; neurogenic claudication.
© 2023 The Authors. Pain Practice published by Wiley Periodicals LLC on behalf of World Institute of Pain.
This is a bar plot that shows the mean improvement in different outcome measures for two different treatments, CMM-Alone and mild+CMM, after one year and two years. The outcome measures are ODI (Oswestry Disability Index), NPRS-Back (Numerical Pain Rating Scale - Back), NPRS-Leg (Numerical Pain Rating Scale - Leg), ZCQ-Symptom severity (Zigler-Scott Questionnaire - Symptom severity), and ZCQ-Physical function (Zigler-Scott Questionnaire - Physical function).
The bar plot shows that the mean improvement in all outcome measures was greater for the mild+CMM treatment than for the CMM-Alone treatment after one year. The difference was particularly large for the ODI and ZCQ-Symptom severity measures. After two years, the mean improvement was still greater for the mild+CMM treatment, but the difference was not as large as after one year.
Overall, the bar plot suggests that the mild+CMM treatment is more effective than the CMM-Alone treatment in improving outcome measures for people with spinal stenosis.
Walking Tolerance:
