This study is for people who continue to have low back pain after spinal surgery, a condition called persistent spinal pain syndrome type II. Current treatments, such as epidural injections, often provide only limited relief. Doctors are testing a procedure called pulsed radiofrequency (PRF), given through a small catheter in the epidural space, with or without the addition of corticosteroids. The goal is to see if this treatment can reduce pain and improve daily function better than standard injections. About 130 patients took part, and their pain and quality of life were followed for several months after the procedure.
Persistent spinal pain syndrome type II (PSPS II) is a frequent and disabling condition encountered in Pain Units after lumbar surgery. Conventional therapeutic options such as epidural corticosteroid injections and epidurolysis often provide only partial or temporary benefit. Pulsed radiofrequency (PRF) delivered through a catheter into the epidural space has shown promising results compared to transforaminal approaches, offering a potential alternative for managing this challenging pain condition. The purpose of this randomized, controlled, multicenter clinical trial is to evaluate the efficacy and safety of epidural PRF with or without the addition of corticosteroids in patients with PSPS II. A total of 131 patients were enrolled and assigned to receive either epidural corticosteroids alone or PRF combined with corticosteroids. Pain intensity, functional status, neuropathic pain features, and global impression of improvement were assessed at multiple follow-up visits. The findings of this study aim to provide evidence-based guidance for interventional pain management in PSPS II.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
131
Pulsed radiofrequency applied via a guidable epidural catheter electrode (Cosman RCE-E401519-P), advanced through the sacral hiatus to the target lumbar or sacral root (L5 and/or S1) under fluoroscopic guidance. Parameters: 45 V, 2 Hz, 20 ms pulses, applied at a single location with continuous temperature monitoring (≤42°C). Procedure performed with Cosman C4 generator.
Epidural injection of 12 mg betamethasone diluted in 8 ml sterile saline, administered via the sacral hiatus under fluoroscopic guidance.
HM Monteprincipe University Hospital
Boadilla del Monte, Madrid, Spain
Hospital Puerta de Hierro
Majadahonda, Madrid, Spain
General Hospital Of Ciudad Real
Ciudad Real, Spain
HM Sanchinarro University Hospital
Madrid, Spain
Change in pain intensity measured by Visual Analogue Scale (VAS)
Change in pain intensity measured by the Visual Analogue Scale (VAS), ranging from 0 (no pain) to 10 (worst imaginable pain).
Time frame: Baseline to 6 months (with assessments at 1, 2, 4, and 6 months).
Change in neuropathic pain measured by DN4 questionnaireeuropathic pain, as measured by DN4 questionnaire
Description: Neuropathic pain assessed using the Douleur Neuropathique 4 Questions (DN4), with scores ranging from 0 to 10. Higher scores indicate greater neuropathic pain.
Time frame: Time Frame: Baseline to 6 months (assessments at 1, 2, 4, and 6 months).
Change in functional disability measured by Oswestry Disability Index (ODI)
Description: Functional disability assessed using the Oswestry Disability Index (ODI), with scores ranging from 0% (no disability) to 100% (maximum disability).
Time frame: Baseline to 6 months (assessments at 1, 2, 4, and 6 months)
Change in overall improvement measured by Patient Global Impression of Improvement (PGI-I) questionnaire
Description: Overall patient improvement assessed using the Patient Global Impression of Improvement (PGI-I) scale, ranging from 1 (very much improved) to 7 (very much worse).
Time frame: Baseline to 6 months (assessments at 1, 2, 4, and 6 months).
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