Am I Eligible? – Clinical Trial Criteria

Wondering if you qualify for the COMFORT clinical trial? If you’ve tried multiple nerve-related chronic pain treatments without success, you might be a candidate. Your doctor at Pain Management & Injury Relief will assess your eligibility to determine if you’re a good candidate.

ABOUT
ELIGIBILITY

Eligibility Requirements

  • Age: 18 to 80 years.
  • Diagnosis: Chronic post-surgical or post-traumatic peripheral nerve pain in areas like the lower back, shoulder, knee, or foot/ankle.
  • Commitment: Willingness to comply with study procedures and attend all visits.
  • Stable Pain: Pain must be consistent for 90 days before enrollment.
  • Medical Treatment: Undergoing stable medical treatment (CMM) for the pain for 30 days before enrollment.
  • Clinician’s Judgment: Deemed a suitable candidate by a healthcare provider for Nalu treatment and study participation.

Exclusion Criteria

  • Implantable Devices: Presence of active implantable devices like drug pumps, spinal cord stimulators, etc.
  • Previous Interventions: Past failed peripheral nerve stimulation, spinal cord stimulation, or dorsal root ganglion therapy.
  • Specific Diagnoses: Diagnosis of complex regional pain syndrome (CRPS) or painful diabetic neuropathy.
  • Concurrent Studies: Participation in another clinical study.
  • Allergies/Intolerance: Allergy or intolerance to Nalu device materials or inability to tolerate its wearable aspect.
  • Legal/Secondary Gain Issues: Ongoing legal disputes or conflicting motivations related to chronic pain.
  • Mental Health: Uncontrolled depression or psychiatric disorders.
  • Pregnancy: Currently pregnant.
  • Language/Consent: Inability to read/write English or provide informed consent.

If you are interested in participating in this clinical trial, please fill out the form below:

"*" indicates required fields

Additional criteria will be discussed by the study staff.

To explore further, please contact us. You can review the detailed study criteria here. Don’t miss the opportunity if you fit the bill!