Efficacy of Pulse Radiofrequency Durations in Lumbosacral Pain

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

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.

Study Overview

• Status: Completed
• Conditions: RADICULAR PAIN
• Intervention / Treatment: Procedure: The duration of the intervention will be 240 seconds; Procedure: Dorsal Root Ganglion pulsed radiofrequency 480sec

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.

• Study Type: Observational
• Enrollment (Actual): 60

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Ankara, Turkey (Türkiye)
    • Ankara Bilkent City Hospital Pain Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients to undergo DRG PRF for lumbar radicular pain in bilkent city hospital algology clinic

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
patients with lumbosacral radicular pain; patients with lumbosacral radicular pain resistant to conservative treatments	Procedure: The duration of the intervention will be 240 seconds; Dorsal Root Ganglion pulsed radiofrequency 240sec; Procedure: Dorsal Root Ganglion pulsed radiofrequency 480sec; The duration of the intervention will be 480 seconds

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Numeric rating scale on pain severity (0 = no pain, 10 = unbearable pain))	Change in pain severity	1, 3, and 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Global perceived effect (GPE)	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	1, 3, and 6 months
Oswetry disability index (ODI)	Change in 10-item Oswestry disability index (ODI) questionnaire (range: 0-100; 0 = no disablility) over time will be used to assess physical function	0, 1, 3, and 6 months
Patient satisfaction	Change in Patient satisfaction (5-point Likert scale, 0= very disappointed, 5=very satisfied) over time will be used	1, 3, and 6 months
Change in analgesic use	Change in analgesic use over time (0=same, 1=decreased, 2=increased)	1, 3, and 6 months

Collaborators and Investigators

• Sponsor: Ankara City Hospital Bilkent

Publications and helpful links

General Publications

• 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.

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): February 7, 2025
• Primary Completion (Actual): September 30, 2025
• Study Completion (Actual): December 30, 2025

Study Registration Dates

• First Submitted: December 18, 2024
• First Submitted That Met QC Criteria: December 22, 2024
• First Posted (Actual): December 27, 2024

Study Record Updates

• Last Update Posted (Actual): January 8, 2026
• Last Update Submitted That Met QC Criteria: January 7, 2026
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: RADICULAR PAIN; PULSED RADIOFREQUENCY; DORSAL ROOT GANGLIA
• Other Study ID Numbers: TABED 1-24-764

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: ı don't want

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No