Clinical trial NCT04374669: Sarcopenia and Outcomes of Neuroplasty in Lumbar Spinal Stenosis
Official title: The Influence of Sarcopenia on Outcomes of Neuroplasty in Patients With Lumbar Spinal Stenosis: a Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Lumbar Spinal Stenosis
Neurogenic Claudication
Sarcopenia
Keywords: Sarcopenia
Frailty
Lumbar spinal stenosis
Neurogenic claudication
Neuroplasty
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
First posted: 2020-05-05
Enrollment: 79
Sex: ALL
Minimum age (years): 65
Maximum age (years): 79
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with lumbar spinal stenosis who is scheduled for neuroplasty in Asan medical center in Korea

Brief summary: The aim of the present study is to find out the influence of sarcopenia on outcomes of neuroplasty in patients with lumbar spinal stenosis.

Detailed description: Frailty is an aging-related syndrome of physiological decline and correlated with sarcopenia. Furthermore, lumbar spinal stenosis is a common disease in the old population and a neuroplasty is widely used to treat these patients. We postulate that the sarcopenia may be associated with the outcome of neuroplasty in patients with lumbar spinal stenosis, and there is no study about this topic as far as we know.

To evaluate this association, we will use the criteria for sarcopenia which is made by Asian Working Group for Sarcopenia in 2019 in this study. We will compare the outcome of neuroplasty in patients with sarcopenia and without sarcopenia using several tools such as numeric rating scale (NRS), Oswestry Disability Index (ODI), and global perceived effect (GPE) score up to 6 months after the procedure.

Eligibility criteria: Inclusion Criteria:

* Presence of lumbar spinal stenosis on MRI
* 65 ≤ age \<79
* Neurogenic claudication due to spinal stenosis
* Chronic pain above than 3 months despite conservative therapies
* Scheduled for neuroplasty with Racz catheter

Exclusion Criteria:

* Allergy to local anesthetics, contrast dye, or steroid
* Use of anticoagulants or antiplatelet medication
* Coagulopathy or Infection at the insertion site
* Neurological or psychiatric disorders
* Hemodynamic instability due to other underlying disorders
* Prior spine instrumentation
* Vascular claudication
* Refusal to participate in the study

Primary outcomes:
measure: Change in numeric rating scale (NRS) at 3 months after the procedure
timeFrame: Before the procedure and 3 months after the procedure
measure: Change in Oswestry disability index (ODI) at 3 months after the procedure
timeFrame: Before the procedure and 3 months after the procedure
measure: Global percieved effect (GPE) score at 3 months after the procedure
timeFrame: 3 months after the procedure
measure: Change in Medication Quantification scale (MQS) at 3 months after the procedure
timeFrame: Before the procedure and 3 months after the procedure
measure: The percentage of successful responders at 3 months after the procedure
timeFrame: 3 months after the procedure
Secondary outcomes:
measure: Change in NRS at 1 and 6 months after the procedure
timeFrame: Before the procedure, and 1 and 6 months after the procedure
measure: Change in ODI at 1 and 6 months after the procedure
timeFrame: Before the procedure, and 1 and 6 months after the procedure
measure: GPE score at 1 and 6 months after the procedure
timeFrame: 1 and 6 months after the procedure
measure: Change in MQS at 1 and 6 months after the procedure
timeFrame: Before the procedure, and 1 and 6 months after the procedure
measure: The percentage of successful responders at 1 and 6 months after the procedure
timeFrame: 1 and 6 months after the procedure
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan medical center
Study officials:
affiliation: Asan Medical Center
name: Doo-Hwan Kim, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bentov I, Kaplan SJ, Pham TN, Reed MJ. Frailty assessment: from clinical to radiological tools. Br J Anaesth. 2019 Jul;123(1):37-50. doi: 10.1016/j.bja.2019.03.034. Epub 2019 May 3.
citation: Racz G, Candido K, Helm S. Neuroplasty Is a Safe, Effective Procedure. Anesth Analg. 2018 Jan;126(1):363. doi: 10.1213/ANE.0000000000002546. No abstract available.
citation: Chen LK, Woo J, Assantachai P, Auyeung TW, Chou MY, Iijima K, Jang HC, Kang L, Kim M, Kim S, Kojima T, Kuzuya M, Lee JSW, Lee SY, Lee WJ, Lee Y, Liang CK, Lim JY, Lim WS, Peng LN, Sugimoto K, Tanaka T, Won CW, Yamada M, Zhang T, Akishita M, Arai H. Asian Working Group for Sarcopenia: 2019 Consensus Update on Sarcopenia Diagnosis and Treatment. J Am Med Dir Assoc. 2020 Mar;21(3):300-307.e2. doi: 10.1016/j.jamda.2019.12.012. Epub 2020 Feb 4.
citation: Yamada Y, Nishizawa M, Uchiyama T, Kasahara Y, Shindo M, Miyachi M, Tanaka S. Developing and Validating an Age-Independent Equation Using Multi-Frequency Bioelectrical Impedance Analysis for Estimation of Appendicular Skeletal Muscle Mass and Establishing a Cutoff for Sarcopenia. Int J Environ Res Public Health. 2017 Jul 19;14(7):809. doi: 10.3390/ijerph14070809.
citation: Choi SS, Lee JH, Kim D, Kim HK, Lee S, Song KJ, Park JK, Shim JH. Effectiveness and Factors Associated with Epidural Decompression and Adhesiolysis Using a Balloon-Inflatable Catheter in Chronic Lumbar Spinal Stenosis: 1-Year Follow-Up. Pain Med. 2016 Mar;17(3):476-487. doi: 10.1093/pm/pnv018. Epub 2015 Dec 7.