Efficacy of Pulse Radiofrequency Durations in Lumbosacral Pain

Ankara City Hospital

Status: Completed

Conditions: RADICULAR PAIN

Treatments: Procedure: The duration of the intervention will be 240 seconds; Procedure: Dorsal Root Ganglion pulsed radiofrequency 480sec

Study type: Observational

Funder types: Other

Identifiers

NCT06748469

TABED 1-24-764

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

60 participants in 1 patient group

patients with lumbosacral radicular pain

Description:

patients with lumbosacral radicular pain resistant to conservative treatments

Treatment:

Procedure: Dorsal Root Ganglion pulsed radiofrequency 480sec

Procedure: The duration of the intervention will be 240 seconds