MiDAS ENCORE: Randomized controlled clinical trial report of 6-month results

Peter S. Staats, Ramsin M. Benyamin, F. McDonnell, J. Waling, R. Haladjian, N. Patel, W. Von Kaenel, B. Chafin, R. Paicius, W. B. Richardson, M. Netherton, S. Li, G. Chartier, S. Golovac, R. Vallejo, M. Verdolin, E. Washabaugh, J. Chatas, L. Bojrab, K. ZaffarkhanH. Sata, S. Kramer, J. Rosenberg, M. Hanowell, R. Lingreen, V. Johnson, Sayed E. Wahezi, D. Choi, C. Kim, R. Bowman, A. Calodney, R. Reinhart, T. Lamer, B. Hoelzer, N. Moghal, W. James, Encore Investigators Midas Encore Investigators

Research output: Contribution to journalArticle

7 Citations (Scopus)

Abstract

Background: Patients suffering from neurogenic claudication due to lumbar spinal stenosis (LSS) often experience moderate to severe pain and significant functional disability. Neurogenic claudication results from progressive degenerative changes in the spine, and most often affects the elderly. Both the MILDR procedure and epidural steroid injections (ESIs) offer interventional pain treatment options for LSS patients experiencing neurogenic claudication refractory to more conservative therapies. MILD provides an alternative to ESIs via minimally invasive lumbar decompression. Study Design: Prospective, multi-center, randomized controlled clinical trial. Setting: Twenty-six US interventional pain management centers. Objective: To compare patient outcomes following treatment with either MILD (treatment group) or ESIs (active control group) in LSS patients with neurogenic claudication and verified ligamentum flavum hypertrophy. Methods: This prospective, multi-center, randomized controlled clinical trial includes 2 study arms with a 1-to-1 randomization ratio. A total of 302 patients were enrolled, with 149 randomized to MILD and 153 to the active control. Six-month follow-up has been completed and is presented in this report. In addition, one year follow-up will be conducted for patients in both study arms, and supplementary 2 year outcome data will be collected for patients in the MILD group only. Outcome Measures: Outcomes are assessed using the Oswestry Disability Index (ODI), numeric pain rating scale (NPRS) and Zurich Claudication Questionnaire (ZCQ). Primary efficacy is the proportion of ODI responders, tested for statistical superiority of the MILD group versus the active control group. ODI responders are defined as patients achieving the validated Minimal Important Change (MIC) of ≥10 point improvement in ODI from baseline to follow-up. Similarly, secondary efficacy includes proportion of NPRS and ZCQ responders using validated MIC thresholds. Primary safety is the incidence of device or procedure-related adverse events in each group. Results: At 6 months, all primary and secondary efficacy results provided statistically significant evidence that MILD is superior to the active control. For primary efficacy, the proportion of ODI responders in the MILD group (62.2%) was statistically significantly higher than for the epidural steroid group (35.7%) (P <0.001). Further, all secondary efficacy parameters demonstrated statistical superiority of MILD versus the active control. The primary safety endpoint was achieved, demonstrating that there is no difference in safety between MILD and ESIs (P = 1.00). Limitations: Limitations include lack of patient blinding due to considerable differences in treatment protocols, and a potentially higher non-responder rate for both groups versus standard-of-care due to study restrictions on adjunctive pain therapies. Conclusions: Six month follow-up data from this trial demonstrate that the MILD procedure is statistically superior to epidural steroids, a known active treatment for LSS patients with neurogenic claudication and verified central stenosis due to ligamentum flavum hypertrophy. The results of all primary and secondary efficacy outcome measures achieved statistically superior outcomes in the MILD group versus ESIs. Further, there were no statistically significant differences in the safety profile between study groups. This prospective, multi-center, randomized controlled clinical trial provides strong evidence of the effectiveness of MILD versus epidural steroids in this patient population.

Original languageEnglish (US)
Pages (from-to)25-37
Number of pages13
JournalPain Physician
Volume19
Issue number2
StatePublished - Feb 1 2016

Fingerprint

Randomized Controlled Trials
Epidural Injections
Steroids
Spinal Stenosis
Pain
Ligamentum Flavum
Safety
Hypertrophy
Outcome Assessment (Health Care)
Pain Clinics
Control Groups
Pain Management
Therapeutics
Standard of Care
Clinical Protocols
Random Allocation
Decompression
Pathologic Constriction
Spine
Prospective Studies

Keywords

  • Interlaminar epidural steroid injection
  • Ligamentum flavum
  • Lumbar central spinal stenosis
  • MILD
  • Minimally invasive lumbar decompression
  • Neurogenic claudication
  • NPRS
  • Numeric pain rating scale
  • ODI
  • Oswestry disability index
  • ZCQ
  • Zurich claudication questionnaire

ASJC Scopus subject areas

  • Anesthesiology and Pain Medicine

Cite this

Staats, P. S., Benyamin, R. M., McDonnell, F., Waling, J., Haladjian, R., Patel, N., ... Midas Encore Investigators, E. I. (2016). MiDAS ENCORE: Randomized controlled clinical trial report of 6-month results. Pain Physician, 19(2), 25-37.

MiDAS ENCORE : Randomized controlled clinical trial report of 6-month results. / Staats, Peter S.; Benyamin, Ramsin M.; McDonnell, F.; Waling, J.; Haladjian, R.; Patel, N.; Von Kaenel, W.; Chafin, B.; Paicius, R.; Richardson, W. B.; Netherton, M.; Li, S.; Chartier, G.; Golovac, S.; Vallejo, R.; Verdolin, M.; Washabaugh, E.; Chatas, J.; Bojrab, L.; Zaffarkhan, K.; Sata, H.; Kramer, S.; Rosenberg, J.; Hanowell, M.; Lingreen, R.; Johnson, V.; Wahezi, Sayed E.; Choi, D.; Kim, C.; Bowman, R.; Calodney, A.; Reinhart, R.; Lamer, T.; Hoelzer, B.; Moghal, N.; James, W.; Midas Encore Investigators, Encore Investigators.

In: Pain Physician, Vol. 19, No. 2, 01.02.2016, p. 25-37.

Research output: Contribution to journalArticle

Staats, PS, Benyamin, RM, McDonnell, F, Waling, J, Haladjian, R, Patel, N, Von Kaenel, W, Chafin, B, Paicius, R, Richardson, WB, Netherton, M, Li, S, Chartier, G, Golovac, S, Vallejo, R, Verdolin, M, Washabaugh, E, Chatas, J, Bojrab, L, Zaffarkhan, K, Sata, H, Kramer, S, Rosenberg, J, Hanowell, M, Lingreen, R, Johnson, V, Wahezi, SE, Choi, D, Kim, C, Bowman, R, Calodney, A, Reinhart, R, Lamer, T, Hoelzer, B, Moghal, N, James, W & Midas Encore Investigators, EI 2016, 'MiDAS ENCORE: Randomized controlled clinical trial report of 6-month results', Pain Physician, vol. 19, no. 2, pp. 25-37.
Staats PS, Benyamin RM, McDonnell F, Waling J, Haladjian R, Patel N et al. MiDAS ENCORE: Randomized controlled clinical trial report of 6-month results. Pain Physician. 2016 Feb 1;19(2):25-37.
Staats, Peter S. ; Benyamin, Ramsin M. ; McDonnell, F. ; Waling, J. ; Haladjian, R. ; Patel, N. ; Von Kaenel, W. ; Chafin, B. ; Paicius, R. ; Richardson, W. B. ; Netherton, M. ; Li, S. ; Chartier, G. ; Golovac, S. ; Vallejo, R. ; Verdolin, M. ; Washabaugh, E. ; Chatas, J. ; Bojrab, L. ; Zaffarkhan, K. ; Sata, H. ; Kramer, S. ; Rosenberg, J. ; Hanowell, M. ; Lingreen, R. ; Johnson, V. ; Wahezi, Sayed E. ; Choi, D. ; Kim, C. ; Bowman, R. ; Calodney, A. ; Reinhart, R. ; Lamer, T. ; Hoelzer, B. ; Moghal, N. ; James, W. ; Midas Encore Investigators, Encore Investigators. / MiDAS ENCORE : Randomized controlled clinical trial report of 6-month results. In: Pain Physician. 2016 ; Vol. 19, No. 2. pp. 25-37.
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title = "MiDAS ENCORE: Randomized controlled clinical trial report of 6-month results",
abstract = "Background: Patients suffering from neurogenic claudication due to lumbar spinal stenosis (LSS) often experience moderate to severe pain and significant functional disability. Neurogenic claudication results from progressive degenerative changes in the spine, and most often affects the elderly. Both the MILDR procedure and epidural steroid injections (ESIs) offer interventional pain treatment options for LSS patients experiencing neurogenic claudication refractory to more conservative therapies. MILD provides an alternative to ESIs via minimally invasive lumbar decompression. Study Design: Prospective, multi-center, randomized controlled clinical trial. Setting: Twenty-six US interventional pain management centers. Objective: To compare patient outcomes following treatment with either MILD (treatment group) or ESIs (active control group) in LSS patients with neurogenic claudication and verified ligamentum flavum hypertrophy. Methods: This prospective, multi-center, randomized controlled clinical trial includes 2 study arms with a 1-to-1 randomization ratio. A total of 302 patients were enrolled, with 149 randomized to MILD and 153 to the active control. Six-month follow-up has been completed and is presented in this report. In addition, one year follow-up will be conducted for patients in both study arms, and supplementary 2 year outcome data will be collected for patients in the MILD group only. Outcome Measures: Outcomes are assessed using the Oswestry Disability Index (ODI), numeric pain rating scale (NPRS) and Zurich Claudication Questionnaire (ZCQ). Primary efficacy is the proportion of ODI responders, tested for statistical superiority of the MILD group versus the active control group. ODI responders are defined as patients achieving the validated Minimal Important Change (MIC) of ≥10 point improvement in ODI from baseline to follow-up. Similarly, secondary efficacy includes proportion of NPRS and ZCQ responders using validated MIC thresholds. Primary safety is the incidence of device or procedure-related adverse events in each group. Results: At 6 months, all primary and secondary efficacy results provided statistically significant evidence that MILD is superior to the active control. For primary efficacy, the proportion of ODI responders in the MILD group (62.2{\%}) was statistically significantly higher than for the epidural steroid group (35.7{\%}) (P <0.001). Further, all secondary efficacy parameters demonstrated statistical superiority of MILD versus the active control. The primary safety endpoint was achieved, demonstrating that there is no difference in safety between MILD and ESIs (P = 1.00). Limitations: Limitations include lack of patient blinding due to considerable differences in treatment protocols, and a potentially higher non-responder rate for both groups versus standard-of-care due to study restrictions on adjunctive pain therapies. Conclusions: Six month follow-up data from this trial demonstrate that the MILD procedure is statistically superior to epidural steroids, a known active treatment for LSS patients with neurogenic claudication and verified central stenosis due to ligamentum flavum hypertrophy. The results of all primary and secondary efficacy outcome measures achieved statistically superior outcomes in the MILD group versus ESIs. Further, there were no statistically significant differences in the safety profile between study groups. This prospective, multi-center, randomized controlled clinical trial provides strong evidence of the effectiveness of MILD versus epidural steroids in this patient population.",
keywords = "Interlaminar epidural steroid injection, Ligamentum flavum, Lumbar central spinal stenosis, MILD, Minimally invasive lumbar decompression, Neurogenic claudication, NPRS, Numeric pain rating scale, ODI, Oswestry disability index, ZCQ, Zurich claudication questionnaire",
author = "Staats, {Peter S.} and Benyamin, {Ramsin M.} and F. McDonnell and J. Waling and R. Haladjian and N. Patel and {Von Kaenel}, W. and B. Chafin and R. Paicius and Richardson, {W. B.} and M. Netherton and S. Li and G. Chartier and S. Golovac and R. Vallejo and M. Verdolin and E. Washabaugh and J. Chatas and L. Bojrab and K. Zaffarkhan and H. Sata and S. Kramer and J. Rosenberg and M. Hanowell and R. Lingreen and V. Johnson and Wahezi, {Sayed E.} and D. Choi and C. Kim and R. Bowman and A. Calodney and R. Reinhart and T. Lamer and B. Hoelzer and N. Moghal and W. James and {Midas Encore Investigators}, {Encore Investigators}",
year = "2016",
month = "2",
day = "1",
language = "English (US)",
volume = "19",
pages = "25--37",
journal = "Pain Physician",
issn = "1533-3159",
publisher = "Association of Pain Management Anesthesiologists",
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}

TY - JOUR

T1 - MiDAS ENCORE

T2 - Randomized controlled clinical trial report of 6-month results

AU - Staats, Peter S.

AU - Benyamin, Ramsin M.

AU - McDonnell, F.

AU - Waling, J.

AU - Haladjian, R.

AU - Patel, N.

AU - Von Kaenel, W.

AU - Chafin, B.

AU - Paicius, R.

AU - Richardson, W. B.

AU - Netherton, M.

AU - Li, S.

AU - Chartier, G.

AU - Golovac, S.

AU - Vallejo, R.

AU - Verdolin, M.

AU - Washabaugh, E.

AU - Chatas, J.

AU - Bojrab, L.

AU - Zaffarkhan, K.

AU - Sata, H.

AU - Kramer, S.

AU - Rosenberg, J.

AU - Hanowell, M.

AU - Lingreen, R.

AU - Johnson, V.

AU - Wahezi, Sayed E.

AU - Choi, D.

AU - Kim, C.

AU - Bowman, R.

AU - Calodney, A.

AU - Reinhart, R.

AU - Lamer, T.

AU - Hoelzer, B.

AU - Moghal, N.

AU - James, W.

AU - Midas Encore Investigators, Encore Investigators

PY - 2016/2/1

Y1 - 2016/2/1

N2 - Background: Patients suffering from neurogenic claudication due to lumbar spinal stenosis (LSS) often experience moderate to severe pain and significant functional disability. Neurogenic claudication results from progressive degenerative changes in the spine, and most often affects the elderly. Both the MILDR procedure and epidural steroid injections (ESIs) offer interventional pain treatment options for LSS patients experiencing neurogenic claudication refractory to more conservative therapies. MILD provides an alternative to ESIs via minimally invasive lumbar decompression. Study Design: Prospective, multi-center, randomized controlled clinical trial. Setting: Twenty-six US interventional pain management centers. Objective: To compare patient outcomes following treatment with either MILD (treatment group) or ESIs (active control group) in LSS patients with neurogenic claudication and verified ligamentum flavum hypertrophy. Methods: This prospective, multi-center, randomized controlled clinical trial includes 2 study arms with a 1-to-1 randomization ratio. A total of 302 patients were enrolled, with 149 randomized to MILD and 153 to the active control. Six-month follow-up has been completed and is presented in this report. In addition, one year follow-up will be conducted for patients in both study arms, and supplementary 2 year outcome data will be collected for patients in the MILD group only. Outcome Measures: Outcomes are assessed using the Oswestry Disability Index (ODI), numeric pain rating scale (NPRS) and Zurich Claudication Questionnaire (ZCQ). Primary efficacy is the proportion of ODI responders, tested for statistical superiority of the MILD group versus the active control group. ODI responders are defined as patients achieving the validated Minimal Important Change (MIC) of ≥10 point improvement in ODI from baseline to follow-up. Similarly, secondary efficacy includes proportion of NPRS and ZCQ responders using validated MIC thresholds. Primary safety is the incidence of device or procedure-related adverse events in each group. Results: At 6 months, all primary and secondary efficacy results provided statistically significant evidence that MILD is superior to the active control. For primary efficacy, the proportion of ODI responders in the MILD group (62.2%) was statistically significantly higher than for the epidural steroid group (35.7%) (P <0.001). Further, all secondary efficacy parameters demonstrated statistical superiority of MILD versus the active control. The primary safety endpoint was achieved, demonstrating that there is no difference in safety between MILD and ESIs (P = 1.00). Limitations: Limitations include lack of patient blinding due to considerable differences in treatment protocols, and a potentially higher non-responder rate for both groups versus standard-of-care due to study restrictions on adjunctive pain therapies. Conclusions: Six month follow-up data from this trial demonstrate that the MILD procedure is statistically superior to epidural steroids, a known active treatment for LSS patients with neurogenic claudication and verified central stenosis due to ligamentum flavum hypertrophy. The results of all primary and secondary efficacy outcome measures achieved statistically superior outcomes in the MILD group versus ESIs. Further, there were no statistically significant differences in the safety profile between study groups. This prospective, multi-center, randomized controlled clinical trial provides strong evidence of the effectiveness of MILD versus epidural steroids in this patient population.

AB - Background: Patients suffering from neurogenic claudication due to lumbar spinal stenosis (LSS) often experience moderate to severe pain and significant functional disability. Neurogenic claudication results from progressive degenerative changes in the spine, and most often affects the elderly. Both the MILDR procedure and epidural steroid injections (ESIs) offer interventional pain treatment options for LSS patients experiencing neurogenic claudication refractory to more conservative therapies. MILD provides an alternative to ESIs via minimally invasive lumbar decompression. Study Design: Prospective, multi-center, randomized controlled clinical trial. Setting: Twenty-six US interventional pain management centers. Objective: To compare patient outcomes following treatment with either MILD (treatment group) or ESIs (active control group) in LSS patients with neurogenic claudication and verified ligamentum flavum hypertrophy. Methods: This prospective, multi-center, randomized controlled clinical trial includes 2 study arms with a 1-to-1 randomization ratio. A total of 302 patients were enrolled, with 149 randomized to MILD and 153 to the active control. Six-month follow-up has been completed and is presented in this report. In addition, one year follow-up will be conducted for patients in both study arms, and supplementary 2 year outcome data will be collected for patients in the MILD group only. Outcome Measures: Outcomes are assessed using the Oswestry Disability Index (ODI), numeric pain rating scale (NPRS) and Zurich Claudication Questionnaire (ZCQ). Primary efficacy is the proportion of ODI responders, tested for statistical superiority of the MILD group versus the active control group. ODI responders are defined as patients achieving the validated Minimal Important Change (MIC) of ≥10 point improvement in ODI from baseline to follow-up. Similarly, secondary efficacy includes proportion of NPRS and ZCQ responders using validated MIC thresholds. Primary safety is the incidence of device or procedure-related adverse events in each group. Results: At 6 months, all primary and secondary efficacy results provided statistically significant evidence that MILD is superior to the active control. For primary efficacy, the proportion of ODI responders in the MILD group (62.2%) was statistically significantly higher than for the epidural steroid group (35.7%) (P <0.001). Further, all secondary efficacy parameters demonstrated statistical superiority of MILD versus the active control. The primary safety endpoint was achieved, demonstrating that there is no difference in safety between MILD and ESIs (P = 1.00). Limitations: Limitations include lack of patient blinding due to considerable differences in treatment protocols, and a potentially higher non-responder rate for both groups versus standard-of-care due to study restrictions on adjunctive pain therapies. Conclusions: Six month follow-up data from this trial demonstrate that the MILD procedure is statistically superior to epidural steroids, a known active treatment for LSS patients with neurogenic claudication and verified central stenosis due to ligamentum flavum hypertrophy. The results of all primary and secondary efficacy outcome measures achieved statistically superior outcomes in the MILD group versus ESIs. Further, there were no statistically significant differences in the safety profile between study groups. This prospective, multi-center, randomized controlled clinical trial provides strong evidence of the effectiveness of MILD versus epidural steroids in this patient population.

KW - Interlaminar epidural steroid injection

KW - Ligamentum flavum

KW - Lumbar central spinal stenosis

KW - MILD

KW - Minimally invasive lumbar decompression

KW - Neurogenic claudication

KW - NPRS

KW - Numeric pain rating scale

KW - ODI

KW - Oswestry disability index

KW - ZCQ

KW - Zurich claudication questionnaire

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JF - Pain Physician

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