The MOTION Study: A Randomized Controlled Trial with Objective Real-World Outcomes for Lumbar Spinal Stenosis Patients Treated with the mild® Procedure: One-Year Results

Timothy R Deer, Shrif J Costandi, Edward Washabaugh, Timothy B Chafin, Sayed E Wahezi, Navdeep Jassal, Dawood Sayed, Timothy R Deer, Shrif J Costandi, Edward Washabaugh, Timothy B Chafin, Sayed E Wahezi, Navdeep Jassal, Dawood Sayed

Abstract

Objective: The purpose of this study is to provide Level-1 objective, real-world outcome data for patients with lumbar spinal stenosis suffering from neurogenic claudication secondary to hypertrophic ligamentum flavum.

Design: The MOTION Study is a prospective, multicenter, randomized controlled trial comparing the mild® Procedure (minimally invasive lumbar decompression; Vertos Medical, Aliso Viejo, CA, USA) as a first-line therapy in combination with nonsurgical conventional medical management (CMM) vs CMM alone as the active control.

Methods: Patients in the test group received the mild Procedure at baseline. Both the mild+CMM group and the control group were allowed unrestricted access to conventional real-world therapies. Patient-reported outcomes included the Oswestry Disability Index, the Zurich Claudication Questionnaire, and the Numeric Pain Rating Scale. A validated Walking Tolerance Test, the incidence of subsequent lumbar spine interventions, and the occurrence of adverse events were used to measure objective outcomes.

Results: Sixty-nine patients in each group were analyzed at 1-year follow-up. No device- or procedure-related adverse events were reported in either group. Results from all primary and secondary outcome measures showed statistical significance in favor of mild+CMM.

Conclusions: One-year results of this Level-1 study demonstrated superiority of mild+CMM over CMM alone for patients with lumbar spinal stenosis who were suffering from neurogenic claudication secondary to hypertrophic ligamentum flavum. Use of the validated Walking Tolerance Test to objectively measure increased ability to walk without severe symptoms provided evidence of statistically significantly better outcomes for mild+CMM than for CMM alone. With no reported device or procedure-related adverse events, the long-standing safety profile of the mild Procedure was reaffirmed. mild is a safe, durable, minimally invasive procedure that has been shown to be effective as an early interventional therapy for patients suffering from symptomatic lumbar spinal stenosis.

Trial registration: ClinicalTrials.gov NCT03610737.

Keywords: mild; Chronic Low Back Pain; Ligamentum Flavum; Lumbar Spinal Stenosis; Minimally Invasive Lumbar Decompression; Neurogenic Claudication.

© The Author(s) 2022. Published by Oxford University Press on behalf of the American Academy of Pain Medicine.

Figures

Figure 1.
Figure 1.
CONSORT diagram for patient flow through 1-year follow-up.
Figure 2.
Figure 2.
Percentage of MOTION patients presenting with multiple types of stenosis and spinal comorbidities. More than 90% of patients presented with foraminal as well as central stenosis, and the majority of patients suffered from all three types of stenosis: foraminal, lateral, and central. Ninety-one percent of patients presented with five or more spinal comorbidities.
Figure 3.
Figure 3.
Walking Tolerance Test mean percent improvement at 6-month and 1-year follow-ups. At 1-year follow-up, mild+CMM patients achieved a mean improvement of 258% in walking time to onset of severe symptoms, compared with a 64% mean improvement for CMM-Alone patients. This difference between groups was statistically significant at both the 6-month and 1-year follow-ups (P < 0.001).
Figure 4.
Figure 4.
Incidence of subsequent lumbar spine interventions at 1-year follow-up. At 1-year follow-up, 26.1% of CMM-Alone patients had undergone a subsequent lumbar spine intervention, compared with 5.8% of mild+CMM patients (P = 0.002). This represents a 4.5-times higher rate of subsequent lumbar spine interventions for patients in the CMM-Alone group than for those in the mild+CMM group.
Figure 5.
Figure 5.
ODI outcomes at 6 months and 1 year. This comparison of ODI mean values over time shows statistically significantly better improvements in the mild+CMM arm than in the CMM-Alone group at both the 6-month and 1-year follow-ups.

References

    1. Baisden JL, Gilbert TJ, Hwang SH, et al.Evidence-Based Clinical Guidelines for Multidisciplinary Spine Care (NASS). Diagnosis and Treatment of Degenerative Lumbar Spinal Stenosis. Burr Ridge, IL: North American Spine Society; 2011.
    1. Levy RM, Deer TR.. Systematic safety review and meta-analysis of procedural experience using percutaneous access to treat symptomatic lumbar spinal stenosis. Pain Med 2012;13(12):1554–61.
    1. Hansson T, Suzuki N, Hebelka H, Gaulitz A.. The narrowing of the lumbar spinal canal during loaded MRI: The effects of the disc and ligamentum flavum. Eur Spine J 2009;18(5):679–86.
    1. Kalichman L, Cole R, Kim DH, et al.Spinal stenosis prevalence and association with symptoms: The Framingham Study. Spine J 2009;9(7):545–50.
    1. Lafian AM, Torralba KD.. Lumbar spinal stenosis in older adults. Rheum Dis Clin North Am 2018;44(3):501–12.
    1. Beyer F, Geier F, Bredow J, et al.Non-operative treatment of lumbar spinal stenosis. Technol Health Care 2016;24(4):551–7.
    1. Bussières A, Cancelliere C, Ammendolia C, et al.Non-surgical interventions for lumbar spinal stenosis leading to neurogenic claudication: A clinical practice guideline. J Pain 2021;22(9):1015–39.
    1. Costandi S, Chopko B, Mekhail M, Dews T, Mekhail N.. Lumbar spinal stenosis: Therapeutic options review. Pain Pract 2015;15(1):68–81.
    1. Jain S, Deer T, Sayed D, et al.Minimally invasive lumbar decompression: A review of indications, techniques, efficacy and safety. Pain Manag 2020;10(5):331–48.
    1. Staats PS, Chafin TB, Golovac S, et al.; MiDAS ENCORE Investigators. Long-term safety and efficacy of minimally invasive lumbar decompression procedure for the treatment of lumbar spinal stenosis with neurogenic claudication: 2-year results of MiDAS ENCORE. Reg Anesth Pain Med 2018;43(7):789–94.
    1. Benyamin RM, Staats PS; MiDAS Encore Investigators. MILD® is an effective treatment for lumbar spinal stenosis with neurogenic claudication: MiDAS ENCORE randomized controlled trial. Pain Physician 2016;19(4):229–42.
    1. Deer T, Kim C, Wahezi SE, Qu H, Sayed D.. Objective real-world outcomes of patients suffering from painful neurogenic claudication treated with the mild® procedure: Interim 6-month report of a randomized controlled trial. J Pain Res 2021;14:1687–97.
    1. Moher D, Hopewell S, Schulz KF, et al.CONSORT 2010 explanation and elaboration: Updated guidelines for reporting parallel group randomised trials. BMJ 2010;340:c869.
    1. Sandella DE, Haig AJ, Tomkins-Lan C, Yamakawa K.. Defining the clinical syndrome of lumbar spinal stenosis: A recursive specialist survey process. PMR 2013;5(6):491–5.
    1. Park JB, Chang H, Lee JK.. Quantitative analysis of transforming growth factor-beta 1 in ligamentum flavum of lumbar spinal stenosis and disc herniation. Spine 2001;26(21):E492–E495.
    1. Bowyer A, Royse C.. A matter of perspective—objective versus subjective outcomes in the assessment of quality of recovery. Best Pract Res Clin Anaesthesiol 2018;32(3-4):287–94.
    1. Page MJ, Higgins JPT, Clayton G, et al.Empirical evidence of study design biases in randomized trials: Systematic review of meta-epidemiological studies. PLoS One 2016;11(7):e0159267.
    1. Moustgaard H, Bello S, Miller FG, Hróbjartsson A.. Subjective and objective outcomes in randomized clinical trials: Definitions differed in methods publications and were often absent from trial reports. J Clin Epidemiol 2014;67(12):1327–34.
    1. Deen HG Jr, Zimmerman RS, Lyons MK, et al.Measurement of exercise tolerance on the treadmill in patients with symptomatic lumbar spinal stenosis: A useful indicator of functional status and surgical outcome. J Neurosurg 1995;83(1):27–30.
    1. Fairbank NCT, Pynsent PB.. The Oswestry Disability Index. Spine 2000;25(22):2940–52.
    1. Stucki G, Daltroy L, Liang NH, et al.Measurement properties of a self-administered outcome measure in lumbar spinal stenosis. Spine 1996;21(7):796–803.
    1. Hara N, Matsudaira K, Masuda K, et al.Psychometric Assessment of the Japanese version of the Zurich Claudication Questionnaire (ZCQ): Reliability and validity. PLoS One 2016;11(7):e0160183.
    1. Williamson A, Hoggart B.. Pain: A review of three commonly used pain rating scales. J Clin Nurs 2005;14(7):798–804.
    1. Mekhail N, Vallejo R, Coleman MH, Benyamin RM.. Long-term results of percutaneous lumbar decompression mild(®) for spinal stenosis. Pain Pract 2012;12(3):184–93.
    1. Deer TR, Kim CK, Bowman RG 2nd, Ranson MT, Yee BS.. Study of percutaneous lumbar decompression and treatment algorithm for patients suffering from neurogenic claudication. Pain Physician 2012;15(6):451–60.
    1. Mekhail N, Costandi S, Abraham B, Samuel SW.. Functional and patient-reported outcomes in symptomatic lumbar spinal stenosis following percutaneous decompression. Pain Pract 2012;12(6):417–25.
    1. Chopko BW. Long-term results of percutaneous lumbar decompression for LSS: Two-year outcomes. Clin J Pain 2013;29(11):939–43.
    1. Wong WH. mild Interlaminar decompression for the treatment of lumbar spinal stenosis: Procedure description and case series with 1-year follow-up. Clin J Pain 2012;28(6):534–8.
    1. Mekhail N, Costandi S, Nageeb G, Ekladios C, Saied O.. The durability of minimally invasive lumbar decompression procedure in patients with symptomatic lumbar spinal stenosis: Long-term follow-up. Pain Pract 2021;21(8):826–35.
    1. Benyamin RM, Staats PS; MiDAS Encore Investigators. MILD® is an effective treatment for lumbar spinal stenosis with neurogenic claudication: MiDAS ENCORE randomized controlled trial. Pain Physician 2016;19(4):229–42.
    1. Brown LL. A double-blind, randomized, prospective study of epidural steroid injection vs. the mild® procedure in patients with symptomatic lumbar spinal stenosis. Pain Pract 2012;12(5):333–41.
    1. Staats PS, Benyamin RM; MiDAS ENCORE Investigators. MiDAS ENCORE: Randomized controlled clinical trial report of 6-month results. Pain Physician 2016;19(2):25–38.
    1. Deer TR, Grider JS, Pope JE, et al.The MIST Guidelines: The lumbar spinal stenosis consensus group guidelines for minimally invasive spine treatment. Pain Pract 2019;19(3):250–74.

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