The effectiveness of percutaneous balloon neuroplasty in patients with lumbar radicular pain caused by lumbar degenerated disc affecting traversing nerve root

The effectiveness of percutaneous balloon neuroplasty in patients with lumbar radicular pain caused by lumbar degenerated disc affecting traversing nerve root: a assessor blind randomized active controlled trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0010980

Enrollment

116

Registered

2025-09-05

Start date

2025-10-01

Completion date

Unknown

Last updated

2025-09-22

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 percutaneous balloon neuroplasty, a balloon catheter is inserted into the epidural space, and intermittent ballooning is performed above the target lesion, on the target lesion,

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) 20-64 years of age 2) Patients with MRI findings confirming that a single level traversing nerve root is in contact with, deviated (or displaced), or compressed by a single level lumbar degenerative disc. 3) Unilateral lumbar radicular pain with NRS score of =6, regardless of the presence of low back pain. 4) Chronic unilateral lumbar radicular pain with a previous failure of conservative management for at least 3 months. 5) Patients with reduction in radicular pain less than 50% or duration of effect less than 1 month after epidural block. 6) Patients who want to participate in this study and write informed consent voluntarily

Exclusion criteria

Exclusion criteria: 1) Bilateral lumbar radicular pain 2) Lumbar degenerative disc involving two or more level 3) Degenerative spondylolisthesis of a Meyerding grade = 2 4) Scoliosis with a Cobb angle of = 30° 5) Spinal stenosis caused by facet joint hypertrophy, ligamentum flavum thickening, or osteophytes 6) Lumbar facet joint syndrome 7) History of prior lumbar spine surgery 8) Contraindications to nerve block including coagulopathy, systemic or injection site infection, or administration of anticoagulation and/or antiplatelet medications 9) Uncontrolled opioid use 10) Patient refusal to participate in this study 11) Allergies or adverse reactions to contrast medium, local anesthetics, or steroids 12) Pregnancy or breastfeeding women 13) Uncontrolled medical or psychiatric conditions

Design outcomes

Primary

Measure	Time frame
Differences in pain intensity of leg pain from baseline	—

Secondary

Measure	Time frame
Pain intensity of leg pain;Pain intensity of back pain;The Korean version of the oswestry disability index;Type and dosage of prescribed pain medications;Global perceived effect;Successful responder rate;Adverse event related to the allocated intervention;Co-intervention during follow-up period	—

Countries

Korea, Republic of

Contacts

Public ContactChan-Sik Kim

Asan Medical Center

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

Outcome results