High-Voltage Pulsed Radiofrequency of the Lumbar Dorsal Root Ganglion for the Treatment of Chronic Lumbar Radicular and Neuropathic Pain; A Prospective, Doble-blinded and Randomized Controlled Trial
- Conditions
- Pulsed RadiofrequencyLumbar Radiculopathy
- Interventions
- Procedure: Radiofrequency
- Registration Number
- NCT06264297
- Lead Sponsor
- Consorci Sanitari de Terrassa
- Brief Summary
The management of chronic lumbar radicular and neuropathic pain is complex and the treatment success rates are low. Pulsed radiofrequency (PRF) has been described in these cases. In order to determine whether high-voltage PRF show better results than PRF a prospective, doble-blinded and randomized study is conducted in patients with chronic lumbar radicular and neuropathic pain.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 98
- Patients over 18 years of age.
- Unilateral pain radiating to the lower extremity (with or without lumbar pain), which clinically corresponds to the path of the corresponding dermatomes.
- Correlation between clinical symptoms and lesion observed by magnetic resonance imaging (MRI).
- Radicular syndrome of three months or more of evolution.
- Normal or pathological electromyogram (EMG).
- Pain with neuropathic characteristics confirmed by the DN4 neuropathic pain questionnaire.
- Patients with a previous positive block diagnosis.
- Patients who have signed the informed consent document.
- Patients under 18 years of age.
- Patients with non-radicular low back pain.
- MRI not consistent with the patient's symptoms.
- Patients with peripheral neuropathy of the lower extremities.
- Patients with a history or current diagnosis of serious mental disorder.
- Patients with moderate or severe cognitive impairment, or evidence of acute or subacute confusional syndrome.
- Infection at the puncture site.
- Coagulation disorders.
- Pregnant patients.
- Patients who refuse to sign the informed consent document.
- Patients allergic to radiological contrast.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description GROUP II Radiofrequency RFP on the affected level or levels will be carried out during three cycles of 120 s, limited to a temperature of 42° and a voltage of 65V GROUP I Radiofrequency RFP on the affected level or levels will be carried out during three cycles of 120 s, limited to a temperature of 42° and a voltage of 45V
- Primary Outcome Measures
Name Time Method OSWESTRY LOW BACK DISABILITY QUESTIONNAIRE From enrollment to the end of treatment at 6 months this questionnaire has been designed to give us information as to how your back pain has affected your ability to manage everyday life
- Secondary Outcome Measures
Name Time Method patient global impression of improvement (pgi-i) score From enrollment to the end of treatment at 6 months is a transition scale that is a single question asking the patient to rate their urinary tract condition now, as compared with how it was prior to before beginning treatment
DN4 - QUESTIONNAIRE From enrollment to the end of treatment at 6 months DN4 - QUESTIONNAIRE To estimate the probability of neuropathic pain, please answer yes or no for each item of the following four questions.
Visual Numeric Scale From enrollment to the end of treatment at 6 months ranging from 0 to 10 was used to measure pain intensity
Categorical scale From enrollment to the end of treatment at 6 months uses adjectives, such as "mild," "moderate," "severe," and excruciating," to describe pain levels.
Trial Locations
- Locations (1)
Consorci Sanitari de Terrassa
🇪🇸Terrassa, Barcelona, Spain