Sarcopenia and Outcomes of Neuroplasty in Lumbar Spinal Stenosis

Active, not recruiting

• Conditions: Lumbar Spinal Stenosis; Neurogenic Claudication; Sarcopenia
• Interventions: Procedure: Neuroplasty with Racz catheter

• Registration Number: NCT04374669
• Lead Sponsor: Asan Medical Center

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.

Study Timeline

• Study First Submitted: 2020-04-24
• Study First Submitted QC: 2020-05-01
• Study First Posted: 2020-05-05
• Study Start: 2020-05-20
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-23
• Last Update Posted: 2022-12-27
• Primary Completion: 2023-04-30
• Study Completion: 2023-04-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 79

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
patients with lumbar spinal stenosis	Neuroplasty with Racz catheter	Patients with lumbar spinal stenosis will be scheduled for neuroplasty.

Primary Outcome Measures

Name	Time	Method
Change in Oswestry disability index (ODI) at 3 months after the procedure	Before the procedure and 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.
Global percieved effect (GPE) score at 3 months after the procedure	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
Change in Medication Quantification scale (MQS) at 3 months after the procedure	Before the procedure and 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.
Change in numeric rating scale (NRS) at 3 months after the procedure	Before the procedure and 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.
The percentage of successful responders at 3 months after the procedure	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.

Secondary Outcome Measures

Name	Time	Method
Change in NRS at 1 and 6 months after the procedure	Before the procedure, and 1 and 6 months after the procedure	We are going to compare the change of NRS at 1 and 6 months after the procedure to the baseline value.
Change in ODI at 1 and 6 months after the procedure	Before the procedure, and 1 and 6 months after the procedure	We are going to compare the change of ODI at 1 and 6 months after the procedure to the baseline value.
GPE score at 1 and 6 months after the procedure	1 and 6 months after the procedure	We are going to check GPE score at 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	We are going to compare the change of MQS at 1 and 6 months after the procedure to the baseline value.
The percentage of successful responders at 1 and 6 months after the procedure	1 and 6 months after the procedure	We are going to evaluate successful responders at 1 and 6 months after the procedure

Trial Locations

Locations (1)

Asan medical center; 🇰🇷 Seoul, Korea, Republic of