None listed
Conditions
Interventions
Procedure/Surgery : With a pillow placed under the lower abdomen, the patient will be placed in the prone position. After aseptic preparation of the needle insertion site, the skin will be anesthetize
Cosman Medical, Burlington, USA) will then be carefully inserted under fluoroscopic guidance (OEC 9800
General Electric Healthcare, Little Chalfont, Buckinghamshire, UK). Once the RF cannula is properly positioned, the stylet will be replaced with RF probe (CB112-TC
Cosman Medical, Burlington, USA). Subsequently, the probe will be connected to the PRF generator (Radiofrequency Ablation for Pain Management, G4™ RF Generator
Cosman Medical, Burlington, USA). The final position of the PRF cannula will be determined by whether or not radicular pain occurs in the patients corresponding nerve segment at a sensory stimulation
Sponsors
Catholic Kwandong University International St.Mary's Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Age =20 years - Pain intensity = NRS 5 points despite two epidural injections - Chronic lumbar radicular pain, duration =12 weeks - Failure of previous conservative treatments such as physical therapy, exercise therapy, or analgesics - Moderate or lesser lumbar neural canal stenosis or disc herniation confirmed by magnetic resonance imaging All eligible patients will receive two conventional diagnostic/therapeutic fluoroscopic image-guided epidural injections with local anesthetic and steroids 2 weeks apart prior to study entry. Patients with no pain reduction or only temporary pain relief from the two epidural injections (pain intensity NRS of 5 or more points on the telephone questionnaire 1 week after the second epidural injection) will be enrolled as subjects.
Exclusion criteria
Exclusion criteria: - Patient refusal - Age NRS 9 points, pain intensity < NRS 5 points - Acute lumbar radicular pain, duration < 12 weeks - Evidence of progressive motor deterioration or neurological deficit - Severe lumbar spinal canal stenosis confirmed by magnetic resonance imaging - Allergy to steroids or contrast media - Blood clotting abnormalities - History of epidural steroid injections within 4 weeks prior to center visit - Systemic infection, injection site infection - Malignant tumors
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome will be the NRS score at 3 months after the procedure. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary outcome will be the number of respondents in each group reporting successful treatment after a 3, 6 months follow-up period. To determine a successful response, the following criteria will be applied: 1) A minimum of 50% reduction in pain intensity measured by the NRS (Numeric Rating Scale) or a decrease of at least 4 points. 2) A 10-point reduction in the ODI (Oswestry Disability Index) or an improvement of 6 or more points on the GPE (Global Perceived Effect) scale. | — |
Countries
Korea, Republic of
Contacts
Public ContactSukhee Park
Catholic Kwandong University International St.Mary's Hospital
Outcome results
None listed