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Search / Trial NCT06301061

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.

Locations

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported