Chronic Low Back Pain, Failed Back Surgery Syndrome, Persistent Spinal Pain Syndrome Type II, Post-Laminectomy Syndrome
Conditions
Keywords
PRF Catheter, Epidural Steroid Injection, Neuropathic Pain, Interventional Pain Management, Epidural Pulsed Radiofrequency
Brief summary
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.
Detailed 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.
Interventions
PROCEDUREEpidural 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.
DRUGBetamethasone (Epidural Corticosteroid Injection)
Epidural injection of 12 mg betamethasone diluted in 8 ml sterile saline, administered via the sacral hiatus under fluoroscopic guidance.
Sponsors
Puerta de Hierro University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
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.
Intervention model description
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).
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in pain intensity measured by Visual Analogue Scale (VAS) | Baseline to 6 months (with assessments at 1, 2, 4, and 6 months). | Change in pain intensity measured by the Visual Analogue Scale (VAS), ranging from 0 (no pain) to 10 (worst imaginable pain). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in neuropathic pain measured by DN4 questionnaireeuropathic pain, as measured by DN4 questionnaire | Time Frame: Baseline to 6 months (assessments at 1, 2, 4, and 6 months). | Description: Neuropathic pain assessed using the Douleur Neuropathique 4 Questions (DN4), with scores ranging from 0 to 10. Higher scores indicate greater neuropathic pain. |
| Change in functional disability measured by Oswestry Disability Index (ODI) | Baseline to 6 months (assessments at 1, 2, 4, and 6 months) | Description: Functional disability assessed using the Oswestry Disability Index (ODI), with scores ranging from 0% (no disability) to 100% (maximum disability). |
| Change in overall improvement measured by Patient Global Impression of Improvement (PGI-I) questionnaire | Baseline to 6 months (assessments at 1, 2, 4, and 6 months). | 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). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number Needed to Treat (NNT) analysis for pain reduction | Baseline to 6 months (assessments at 1, 2, 4, and 6 months). | Description: Number Needed to Treat (NNT) will be calculated based on the proportion of patients achieving clinically relevant reductions in pain intensity on the VAS (e.g., ≥2-point or ≥3-point reduction). Lower NNT values indicate greater treatment efficacy |
Countries
Spain
Outcome results
None listed