RADICULAR PAIN
Conditions
Keywords
RADICULAR PAIN, DORSAL ROOT GANGLIA, PULSED RADIOFREQUENCY
Brief summary
Brief Summary: This study aims to compare the efficacy of short-duration (240 sec) and long-duration (480 sec) pulsed radiofrequency (PRF) applications on pain, functionality, patient satisfaction, and side effect profiles in patients with lumbosacral radicular pain. The PRF procedure will be applied to the dorsal root ganglion (DRG) under fluoroscopic guidance.
Detailed description
In this study, all procedures will be performed in the prone position under sterile conditions and guided by fluoroscopy. After identifying anatomical landmarks, the cannula will be positioned close to the dorsal root ganglion. The tip of the cannula will be placed in the dorsal-cranial quadrant of the intervertebral foramen in the lateral view, and between one-third and halfway along the pedicle column in the anteroposterior view. Once the RF cannula is properly positioned, an RF electrode will be inserted through the cannula and connected to the RF generator. The final position of the RF cannula will be confirmed by sensory stimulation (paresthesia) at less than 0.5 V and motor stimulation perceived at a level at least 1.5 times greater than the sensory stimulation threshold. In the short-duration PRF group, a PRF cycle will be applied at 42°C for 240 seconds, while in the long-duration group, it will be applied at 42°C for 480 seconds. Following the PRF application, epidural spread will be confirmed using contrast dye, after which 4 mL of a solution containing 8 mg dexamethasone and 5 mg bupivacaine will be injected at each level.
Interventions
PROCEDUREThe duration of the intervention will be 240 seconds
Dorsal Root Ganglion pulsed radiofrequency 240sec
PROCEDUREDorsal Root Ganglion pulsed radiofrequency 480sec
The duration of the intervention will be 480 seconds
Sponsors
Ankara City Hospital Bilkent
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Age ≥ 18 years * Pain severity NRS ≥ 4 * Pain duration \> 12 weeks Refractory to conservative treatments (physical therapy, medical treatments)
Exclusion criteria
Malignancy-related pain Diagnosis of diabetes mellitus or polyneuropathy Back pain more severe than leg pain Conditions that impair follow-up (e.g., psychiatric disorders, dementia) Patients refusing the procedure
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Numeric rating scale on pain severity (0 = no pain, 10 = unbearable pain)) | 1, 3, and 6 months | Change in pain severity |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Global perceived effect (GPE) | 1, 3, and 6 months | Change in GPE scores according to the 7-point Likert scale (1=worst, 7=best) over time will be used to assess patient satisfaction and improvement |
| Oswetry disability index (ODI) | 0, 1, 3, and 6 months | Change in 10-item Oswestry disability index (ODI) questionnaire (range: 0-100; 0 = no disablility) over time will be used to assess physical function |
| Patient satisfaction | 1, 3, and 6 months | Change in Patient satisfaction (5-point Likert scale, 0= very disappointed, 5=very satisfied) over time will be used |
| Change in analgesic use | 1, 3, and 6 months | Change in analgesic use over time (0=same, 1=decreased, 2=increased) |
Countries
Turkey (Türkiye)
Outcome results
None listed