Focal Microvibration and Chronic Lumbosacral Radicular Pain
Launched by FEDERICO II UNIVERSITY · Mar 3, 2024
Trial Information
Current as of July 26, 2025
Not yet recruiting
Keywords
ClinConnect Summary
This clinical trial is examining a new treatment called focal microvibration to see if it can help people suffering from chronic lumbosacral radicular pain, which is a type of nerve pain that can occur in the lower back and legs. The main goals are to find out if this treatment can reduce pain and improve the quality of life for patients. Participants will wear small devices that deliver gentle vibrations to the painful area for six hours a day, except on Thursdays and Sundays. The researchers will compare the results from those using the microvibration devices to those using a fake device and those receiving regular medication for pain.
To participate in this trial, individuals should have had pain for at least six months, have evidence of nerve root compression shown by an MRI, and experience moderate to severe pain. However, certain people, like those with psychiatric issues, cancer, or specific neurological diseases, are not eligible for this study. The trial is not yet recruiting participants, but it aims to provide valuable insights into a new potential treatment for chronic pain.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Pain duration≥6 months
- • Magnetic resonance imaging (MRI) showing compression of lumbosacral nerve roots
- • Neuropathic symptoms in the innervation territory of the compressed spinal nerve roots
- • Monolateral pain
- • Pain intensity: moderate-severe i.e. numeric rating scale (NRS)≥4.
- Exclusion Criteria:
- • Psychiatric patients
- • Cancer patients
- * Patients affected by disease characterized by spasticity or muscular stiffness:
- • Parkinson's disease, multiple sclerosis, stroke, spine injuries.
- • Patients with spinal or dorsal root ganglion stimulators
- • Patients undergone central of peripheral stimulation in the past 3 months
- • Patients affected by fibromyalgia.
- • Patients undergone central nervous system surgery
- • Patients with reduced renal function eGFR≤60ml/min/1,73m2
About Federico Ii University
Federico II University, located in Naples, Italy, is a prestigious academic institution with a strong emphasis on advanced research and clinical innovation. As a clinical trial sponsor, the university is committed to fostering the development of novel therapeutic interventions and enhancing patient care through rigorous scientific inquiry. With a multidisciplinary approach, Federico II University collaborates with healthcare professionals, researchers, and industry partners to conduct high-quality clinical trials that adhere to ethical standards and regulatory requirements. Its dedication to improving health outcomes is reflected in its robust research programs and commitment to translating scientific findings into clinical practice.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported