Clinical trial NCT06748469: Efficacy of Pulse Radiofrequency Durations in Lumbosacral Pain
Official title: Analgesic Efficacy of Different Pulse Radiofrequency Treatment Durations in the Management of Lumbosacral Radicular Pain
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: RADICULAR PAIN
Keywords: RADICULAR PAIN
DORSAL ROOT GANGLIA
PULSED RADIOFREQUENCY
Lead sponsor: Ankara City Hospital Bilkent
Sponsor class: OTHER
First posted: 2024-12-27
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients to undergo DRG PRF for lumbar radicular pain in bilkent city hospital algology clinic

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.

Eligibility criteria: 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

Primary outcomes:
measure: Numeric rating scale on pain severity (0 = no pain, 10 = unbearable pain))
timeFrame: 1, 3, and 6 months
Secondary outcomes:
measure: Global perceived effect (GPE)
timeFrame: 1, 3, and 6 months
measure: Oswetry disability index (ODI)
timeFrame: 0, 1, 3, and 6 months
measure: Patient satisfaction
timeFrame: 1, 3, and 6 months
measure: Change in analgesic use
timeFrame: 1, 3, and 6 months
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara Bilkent City Hospital Pain Medicine
Study officials:
References:
citation: Wan C, Dong DS, Song T. High-Voltage, Long-Duration Pulsed Radiofrequency on Gasserian Ganglion Improves Acute/Subacute Zoster-Related Trigeminal Neuralgia: A Randomized, Double-Blinded, Controlled Trial. Pain Physician. 2019 Jul;22(4):361-368.