Health TrialsbyHealthPanel

Retrospective-Prospective PNS Study

ConditionChronic Pain
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCuronix LLC

About this trial

This is a retrospective-prospective study in which 40 patients have received a permanent Freedom PNS System. Subjects presented with chronic, intractable pain of peripheral nerve origin refractory to standard medical and/or surgical treatment.

A retrospective chart review will be conducted to assess baseline and follow-up parameters in patients who have received a permanent implant with the Freedom PNS system for at least 12 months. Missing data might be collected after informed consent.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Single group

Treatments tested in this trial

  • PNS device, observational study, no intervention during study

    Device

    PNS device, observational study, no intervention during study

Treatment groups

40 Participants
are divided into 1 treatment group
Group A: ObservationalExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Pain scores

A text description of the subject's pain location(s) and severity will be recorded to correlate with subject feedback. The VRS will be used to measure severity.

Time frame
12 months

Secondary outcomes

1

Opioids

Each subject's opioid medication type, dose, frequency, and method of administration will be recorded at baseline and follow-up visit.

Time frame
12 months
2

Work status

Work history and status will be evaluated based on a subject's self-reported questionnaire(s) completed at screening/baseline and all follow up visits.

Time frame
12 months
3

GPES

Subject satisfaction with the implant will be measured by assessing global perceived effects (GPES) on a 7-point scale (1 = worst and 7 = best)

Time frame
12 months
4

Amount of sleep

Average hours of sleep per night will be evaluated at baseline and all follow-up visits

Time frame
12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Curonix LLC

Lead sponsor

MetroHealth System, Ohio

Collaborator

Source ClinicalTrials.gov
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