Efficacy of Pulse Radiofrequency Durations in Lumbosacral Pain

Recruiting

• Conditions: RADICULAR PAIN

• Registration Number: NCT06748469
• Lead Sponsor: Ankara City Hospital Bilkent

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.

Study Timeline

• Study First Submitted: 2024-12-18
• Study First Submitted QC: 2024-12-22
• Study First Posted: 2024-12-27
• Status Verified: 2025-02
• Study Start: 2025-02-07
• Last Update Submitted: 2025-02-07
• Last Update Posted: 2025-02-11
• Primary Completion: 2025-09-30
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Numeric rating scale on pain severity (0 = no pain, 10 = unbearable pain))	1, 3, and 6 months	Change in pain severity

Secondary Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

Ankara Bilkent City Hospital Pain Medicine; 🇹🇷 Ankara, Turkey