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
CompletedNot applicableNCT07156513
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- Pulsed Epidural Radiofrequency Versus Epidural Steroid Injection in Patients With Failed Back Syndrome
- Conditions
- Persistent Spinal Pain Syndrome Type II
- Failed Back Surgery Syndrome
- Chronic Low Back Pain
- Post-Laminectomy Syndrome
- Interventions
- Procedure: Epidural Pulsed Radiofrequency
- Drug: Betamethasone (Epidural Corticosteroid Injection)
- Sponsor
- Puerta de Hierro University Hospital
- Start date
- 2021-01-02
- Primary completion
- 2024-03-30
- Sex
- All
- Age range
- from 18 Years
- Results posted
- No results posted in this snapshot
- Countries
- Spain
- Total sites listed
- 4
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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.
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT07156513