Clinical Trials Directory

Trials / Completed

CompletedNCT06748469

Efficacy of Pulse Radiofrequency Durations in Lumbosacral Pain

Analgesic Efficacy of Different Pulse Radiofrequency Treatment Durations in the Management of Lumbosacral Radicular Pain

Status
Completed
Phase
Study type
Observational
Enrollment
60 (actual)
Sponsor
Ankara City Hospital Bilkent · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
PROCEDUREThe duration of the intervention will be 240 secondsDorsal Root Ganglion pulsed radiofrequency 240sec
PROCEDUREDorsal Root Ganglion pulsed radiofrequency 480secThe duration of the intervention will be 480 seconds

Timeline

Start date
2025-02-07
Primary completion
2025-09-30
Completion
2025-12-30
First posted
2024-12-27
Last updated
2026-01-08

Locations

1 site across 1 country: Turkey (Türkiye)

Source: ClinicalTrials.gov record NCT06748469. Inclusion in this directory is not an endorsement.