The effect of transforaminal balloon decompressive neuroplasty in patients with lumbar spinal stenosis: Double Blind Randomized Controlled Trial

The effect of transforaminal balloon decompressive neuroplasty in patients with lumbar spinal stenosis

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0000068

Enrollment

Registered

2010-12-22

Start date

2010-12-13

Completion date

Unknown

Last updated

2019-03-11

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 : transforaminal balloon decompressive neuroplasty

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) The patients with spinal stenosis which is confirmed by magnetic resonance image, and the chief complaint lesion is identical to their radiologic finding. 2) Intractable pain is consited over 6 month of conventional intervention, and the pain is intolerable

Exclusion criteria

Exclusion criteria: 1) Patients who did not want to participate in clinical trial 2) acute back or leg pain, patients who developed signs of progressive motor weakness or neurologic deficit including muscle atrophy and abnormal tendon reflexes, the patients with a history of prior spine surgery 3) allergic response to steroid or contrast dye, or overt coagulopathy. 4) Bilateral radiculopathy or spinal stenosis at more than 3-level on imaging

Design outcomes

Primary

Measure	Time frame
Oswestry Disability Index;intermittent neurogenic claudication distance;Visual Analogue Pain Scale	—

Secondary

Measure	Time frame
Proportion of patient achieving >50% pain reduction	—

Countries

Korea, Republic of

Contacts

Public ContactSung-Hoon Kim

Asan Medical Center

Outcome results