Comparison of Percutaneous Epidural Balloon Neuroplasty with Full-Endoscopic Lumbar Decompression in Patients with Chronic Central or Lateral Recess Stenosis

Not Applicable

Recruiting

Conditions: Diseases of the musculoskeletal system and connective tissue

Registration Number: KCT0007243

Lead Sponsor: Asan Medical Center

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 30

Inclusion Criteria

1) 19–79 years of age
2) Chronic (at least 12 weeks) lumbar radicular pain with a previous failure of conservative management
3) Central or lateral recess stenosis diagnosed by symptom, sign, and image
4) Single level central or lateral recess stenosis of grade 3–4
5) Patients who want to participate in this study and write informed consent voluntarily

Exclusion Criteria

1) Combined foraminal stenosis in the same or lower level
2) Segmental instability
3) Degenerative spondylolisthesis of a Meyerding grade > I
4) Scoliosis with a Cobb angle of >30°
5) History of prior lumbar spine surgery
6) Allergies or adverse reactions to contrast dye, local anesthetics, or steroids
7) Contraindications to nerve block (including coagulopathy, systemic or injection site infection, or administration of anticoagulation and/or antiplatelet medications)
8) Neurological or psychiatric disorders
9) Unstable medical condition
10) Pregnancy
11) Patient refusal to participate in this study

Study & Design

Study Type: Interventional Study

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mean differences in pain intensity of leg pain from baseline (Numerical Rating Scale, NRS, 0–10)

Secondary Outcome Measures

Name	Time	Method
Mean differences in pain intensity of leg pain from baseline (Numerical Rating Scale, NRS, 0–10);Mean differences in pain intensity of back pain from baseline (Numerical Rating Scale, NRS, 0–10);Mean differences in the Korean version of the oswestry disability index from baseline (the Korean version of the oswestry disability index, ODI, 10–60);Prescribed pain medication and mean differences in Medication Quantification Scale(MQS);Global perceived effect (GPE, 1–7);Types and frequency of conservative procedures after received allocated intervention;Adverse event related to the allocated intervention