NCT04374669

Sarcopenia and Outcomes of Neuroplasty in Lumbar Spinal Stenosis

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 79 (estimated)
• Sponsor: Asan Medical Center · Academic / Other
• Sex: All
• Age: 65 Years – 79 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Lumbar Spinal Stenosis
• Neurogenic Claudication
• Sarcopenia

Interventions

Type	Name	Description
PROCEDURE	Neuroplasty with Racz catheter	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.

Timeline

• Start date: 2020-05-20
• Primary completion: 2023-04-30
• Completion: 2023-04-30
• First posted: 2020-05-05
• Last updated: 2022-12-27

Locations

1 site across 1 country: South Korea