Comparing the effectiveness of pulsed radiofrequency treatment of the lumbar dorsal root ganglion at different application times in patients with lumbar radiculopathy

Not Applicable

Recruiting

Conditions: Diseases of the musculoskeletal system and connective tissue

Registration Number: KCT0008612

Lead Sponsor: Catholic Kwandong University International St.Mary's Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 60

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

- Patient refusal
- Age < 20 years
- Pain intensity > 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

Study & Design

Study Type: Interventional Study

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome will be the NRS score at 3 months after the procedure.

Secondary Outcome Measures

Name	Time	Method
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.