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 (EPIPUL)

Majadahonda Iron Gate University

Status: Completed

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

Treatments: Drug: Betamethasone (Epidural Corticosteroid Injection); Procedure: Epidural Pulsed Radiofrequency

Study type: Interventional

Funder types: Other

Identifiers

NCT07156513

Epipul Study

Comité Ético de HM Hospital (Other Identifier)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 131 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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131 participants in 2 patient groups

Experimental Arm

Experimental group

Description:

Participants received epidural pulsed radiofrequency with corticosteroid injection.

Treatment:

Procedure: Epidural Pulsed Radiofrequency

Drug: Betamethasone (Epidural Corticosteroid Injection)

Control Arm: Epidural Corticosteroid Injection

Active Comparator group

Description:

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

Treatment:

Drug: Betamethasone (Epidural Corticosteroid Injection)