Sarcopenia and Outcomes of Neuroplasty in Lumbar Spinal Stenosis

NCT04374669 | Unknown

• 1 other identifier: S2020-0855-0001
• Study Type: observational
• Target: 79
• Locations: 1 country
• Sites: 1

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.

Conditions

Lumbar Spinal Stenosis; Neurogenic Claudication; Sarcopenia

Keywords

Sarcopenia; Frailty; Lumbar spinal stenosis; Neurogenic claudication; Neuroplasty

Outcome Measures

Primary Outcomes (5)

• Change in numeric rating scale (NRS) at 3 months after the procedure

  Numeric rating scale (0-10) 0=no pain, 10=worst pain imaginable We are going to compare the change of NRS at 3 months after the procedure to the baseline value.

  Before the procedure and 3 months after the procedure

• Change in Oswestry disability index (ODI) at 3 months after the procedure

  Oswestry disability index (10-60) 10: least score as possible, 60: most score as possible We are going to compare the change of ODI at 3 months after the procedure to the baseline value.

  Before the procedure and 3 months after the procedure

• Global percieved effect (GPE) score at 3 months after the procedure

  Global percieved effect score by Likert scale (1-7) 1: Never satisfied with the procedure, 7: Very satisfied with the procedure

  3 months after the procedure

• Change in Medication Quantification scale (MQS) at 3 months after the procedure

  Medication quantification scale is a tool to quantify medication regimen use in chronic pain populations. We are going to use Medication Quantification scale ver 3. The score starts at 0, and there is no specific maximum limit. We are going to compare the change of MQS at 3 months after the procedure to the baseline value.

  Before the procedure and 3 months after the procedure

• The percentage of successful responders at 3 months after the procedure

  We are going to assess 4 variables above and then decide who is a successful responder or not at 3 months after the procedure. We defined the successful responders as follows; 1. ≥ 50% or 4-point reduction from baseline leg Numeric rating scale and no increase from baseline Oswestry disability index and medication quantification scale and 4 points on the global perceived scale, 2. ≥ 30% or 2 points reduction from baseline numeric rating scale with any one of the following criteria: simultaneous ≥ 30% (or 10-point) reduction in Oswestry disability index from baseline, or ≥ 5 points on global perceived effects scale, or no increase from the baseline medication quantification scale. NRS, ODI, and MQS will be evaluated before the procedure and become baseline values. NRS, ODI, and MQS will be re-evaluated, and GPE score will be newly evaluated 3 months after the procedure.

  3 months after the procedure

Secondary Outcomes (5)

• Change in NRS at 1 and 6 months after the procedure

  Before the procedure, and 1 and 6 months after the procedure

• Change in ODI at 1 and 6 months after the procedure

  Before the procedure, and 1 and 6 months after the procedure

• GPE score at 1 and 6 months after the procedure

  1 and 6 months after the procedure

• Change in MQS at 1 and 6 months after the procedure

  Before the procedure, and 1 and 6 months after the procedure

• The percentage of successful responders at 1 and 6 months after the procedure

  1 and 6 months after the procedure

Study Arms (1)

patients with lumbar spinal stenosis

Patients with lumbar spinal stenosis will be scheduled for neuroplasty.

Procedure: Neuroplasty with Racz catheter

Interventions

Neuroplasty with Racz catheter PROCEDURE

The patient is placed in the prone position with a pillow placed under the abdomen to correct the lumbar lordosis. After sterile preparation and draping, the epidural space via the sacral hiatus using a 16 gauge needle is accessed. Then, the Racz catheter is advanced to the site of adhesions under the fluoroscopic guidance. The target site is determined by the location of pathology on lumbar MRI, preprocedural epidurography, and clinical symptoms before the adhesiolysis. Adhesiolysis is performed through the high-volume administration of medications, which consist of a combination of a steroid, local anesthetics, hyaluronidase, and 5% hypertonic saline. As needed, the catheter remains in the epidural space for two days, with the additional injection on each of the days.

patients with lumbar spinal stenosis

Eligibility Criteria

• Age: 65 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with lumbar spinal stenosis who is scheduled for neuroplasty in Asan medical center in Korea

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Asan Medical Center: lead

Study Sites (1)

Asan medical center

Seoul, 05505, South Korea

Location

Related Publications (5)

• 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.

  PMID: 31056240 BACKGROUND

• 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.

  PMID: 29135599 BACKGROUND

• 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.

  PMID: 32033882 BACKGROUND

• 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.

  PMID: 28753945 BACKGROUND

• 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.

  PMID: 26814254 BACKGROUND

MeSH Terms

Conditions

Spinal Stenosis; Sarcopenia; Frailty

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pathologic Processes

Study Officials

• Doo-Hwan Kim, M.D.

  Asan Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 24, 2020
• First Posted: May 5, 2020
• Study Start: May 20, 2020
• Primary Completion: April 30, 2023
• Study Completion: April 30, 2023
• Last Updated: December 27, 2022

Record last verified: 2022-12

Locations

KR (1)