Persistent Post-Lumbar Surgery Pain Syndrome (PSPS) Type II is a Common Condition Encountered in Pain Units, With Limited Available Therapeutic Options. Epidural Pulsed Radiofrequency (PRF) Administered Via Catheter Has Demonstrated Greater Efficacy Compared to the Transforaminal Approach. This Rand

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

131 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-02

Study Completion Date

2024-04-02

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Persistent Spinal Pain Syndrome Type II Failed Back Surgery Syndrome Chronic Low Back Pain Post-Laminectomy Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This is a randomized, controlled, multicenter, parallel-group study. Participants were assigned in a 1:1 ratio to receive either epidural corticosteroid injection alone (control group) or epidural pulsed radiofrequency combined with corticosteroid injection (experimental group).

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Participants were blinded to treatment assignment. Care providers and investigators were aware of group allocation in order to perform the procedures. No additional parties were masked.

Study Groups

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Experimental Arm

Participants received epidural pulsed radiofrequency with corticosteroid injection.

Group Type EXPERIMENTAL

Epidural Pulsed Radiofrequency

Intervention Type PROCEDURE

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.

Betamethasone (Epidural Corticosteroid Injection)

Intervention Type DRUG

Epidural injection of 12 mg betamethasone diluted in 8 ml sterile saline, administered via the sacral hiatus under fluoroscopic guidance.

Control Arm: Epidural Corticosteroid Injection

Participants received an epidural injection of 12 mg betamethasone in 8 ml sterile saline without pulsed radiofrequency.

Group Type ACTIVE_COMPARATOR

Betamethasone (Epidural Corticosteroid Injection)

Intervention Type DRUG

Epidural injection of 12 mg betamethasone diluted in 8 ml sterile saline, administered via the sacral hiatus under fluoroscopic guidance.

Interventions

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Epidural Pulsed Radiofrequency

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.

Intervention Type PROCEDURE

Betamethasone (Epidural Corticosteroid Injection)

Epidural injection of 12 mg betamethasone diluted in 8 ml sterile saline, administered via the sacral hiatus under fluoroscopic guidance.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Men and women over 18 years old.
2. Written informed consent obtained according to ICH/GCP and Spanish legislation prior to any study procedure.
3. Pain VAS score of at least 5 points.
4. Duration of pain lasting at least 3 months after back surgery despite conservative treatment.
5. Leg-dominant radicular pain deemed neuropathic based on clinical history and examination.
6. Responsiveness to selective radicular nerve block with bupivacaine 0.125%.
7. Previous epidural steroid injection.

Exclusion Criteria

1\. Pregnancy or lactation. 2. Participation in a study involving medicines or other clinical devices 4. Inability to follow instructions or collaborate during the study. 5. Findings in physical examination, clinical analysis abnormalities, or other medical, social, or psychosocial factors that, in the researcher's opinion, could negatively influence study outcomes 6. Presence of myelopathy, systemic diseases, infection (systemic or local), cancer, indication for immediate surgery, coagulation disorders, anticoagulants use, diabetes mellitus or multiple sclerosis.

7\. Life expectancy of less than one year. 8. Current diagnosis of a progressive neurological disease.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No