Status:
COMPLETED
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
Lead Sponsor:
Puerta de Hierro University Hospital
Conditions:
Persistent Spinal Pain Syndrome Type II
Failed Back Surgery Syndrome
Eligibility:
All Genders
18+ years
Phase:
NA
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 pro...
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...
Eligibility Criteria
Inclusion
- Men and women over 18 years old.
- Written informed consent obtained according to ICH/GCP and Spanish legislation prior to any study procedure.
- Pain VAS score of at least 5 points.
- Duration of pain lasting at least 3 months after back surgery despite conservative treatment.
- Leg-dominant radicular pain deemed neuropathic based on clinical history and examination.
- Responsiveness to selective radicular nerve block with bupivacaine 0.125%.
- Previous epidural steroid injection.
Exclusion
- 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.
Key Trial Info
Start Date :
January 2 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 2 2024
Estimated Enrollment :
131 Patients enrolled
Trial Details
Trial ID
NCT07156513
Start Date
January 2 2021
End Date
April 2 2024
Last Update
September 5 2025
Active Locations (4)
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1
HM Monteprincipe University Hospital
Boadilla del Monte, Madrid, Spain, 28660
2
Hospital Puerta de Hierro
Majadahonda, Madrid, Spain, 28222
3
General Hospital Of Ciudad Real
Ciudad Real, Spain, 13005
4
HM Sanchinarro University Hospital
Madrid, Spain, 28050