Sarcopenia and Outcomes of Neuroplasty in Lumbar Spinal Stenosis

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Influence of Sarcopenia on Outcomes of Neuroplasty in Patients With Lumbar Spinal Stenosis: a Prospective Observational Study

Conditions
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Lumbar Spinal Stenosis, Neurogenic Claudication, Sarcopenia

Intervention / Treatment
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* Procedure: Neuroplasty with Racz catheter


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| patients with lumbar spinal stenosis<br>Patients with lumbar spinal stenosis will be scheduled for neuroplasty. | Procedure: Neuroplasty with Racz catheter<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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; ≥ 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, ≥ 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 Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sarcopenia, Frailty, Lumbar spinal stenosis, Neurogenic claudication, Neuroplasty