Lumbar Radiculopathy, Pulsed Radiofrequency
Conditions
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.
Interventions
PROCEDURERadiofrequency
Pulsed radiofrequency (PRF) is a nonablative pain treatment that uses radiofrequency current in short high-voltage bursts, resulting in interruption of nociceptive afferent pathways. This study aims to show how the variation in radiofrequency voltage applied to the dorsal root ganglion (DRG) affects the treatment of neuropathic pain.
Sponsors
Consorci Sanitari de Terrassa
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 |
Countries
Spain
Contacts
Primary ContactMaria Martinez
Backup ContactMaria Martinez
Outcome results
None listed