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

Comparison of Percutaneous Epidural Balloon Neuroplasty with Full-Endoscopic Lumbar Decompression in Patients with Chronic Central or Lateral Recess Stenosis: A randomized assessor-blind non-inferiority pilot study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0007243

Enrollment

Registered

2022-04-29

Start date

2022-06-20

Completion date

Unknown

Last updated

2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Procedure/Surgery : In full-endoscopic lumbar decompression via interlaminar approach, a cranial and caudal laminotomy, partial facetectomy, and flavectomy are performed with a drill and punch to deco

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
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	—

Measure

Time frame

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

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Countries

Korea, Republic of

Contacts

Public ContactChan-Sik Kim

Asan Medical Center

chansik.kim86@gmail.com+82-2-3010-3868

Outcome results