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Mechanisms of Stimulation for Pain Alleviation

ConditionsPeripheral Nerve StimulationChronic Neuropathic PainChronic Neuropathic Pain (Below the Shoulders)
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorStanford University

About this trial

This is a mechanistic randomized controlled trial of patients with chronic neuropathic pain (CNP) in the upper extremities, lower back, pelvis, and lower extremities, randomized to conventional medical management (CMM) or combined CMM and peripheral nerve stimulation therapy (PNS+CMM). Our goal is to compare treatment outcomes and trial response rate across the control and interventional device groups.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Peripheral Nerve Stimulation

    Device

    This trial studies 2 FDA approved peripheral nerve stimulation devices that may reduce pain by sending electrical pulses to the nerve. The SPR SPRINT PNS System, a matchbox-sized, battery-powered wearable stimulator that uses a Mircrolead to deliver stimulation for pain relief. There is a small wireless hand-held remote that is used to activate/ adjust intensity of stimulation. Stimulation delivered by this device may interrupt pain signals and increase non-pain signals. The SPR SPRINT device is used for 60 days before the percutaneous Microlead(s) are removed. The Nalu PNS System, a dime-sized micro-implantable pulse generator (IPG) leveraging advanced microelectronics. The micro-IPG is powered by an externally worn therapy disc via radiofrequency worn over the IPG site with an adhesive clip applied to the skin or a relief belt. The device is remote-controlled by patients via an app.

  • Conventional Care Regimen

    Procedure/Surgery

    CMM-Only participants will receive conventional medical management for the duration of their time in the study.

Treatment groups

148 Participants
are divided into 2 treatment groups
Group A: Conventional Medical Management (CMM) ONLYActive comparator 1 intervention
Group B: Peripheral Nerve Stimulation + Conventional Medical Management (PNS+CMM)Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Treatment Response: defined as 50% relief of average pain intensity at the area of the upper extremities, lower back, pelvic, or lower extremity CNP. We will compare the means of a 3-day diary of numeric rating scale of pain (NRS) intensity scores.

We will compare the mean of a three-day diary of numeric rating scale of pain (NRS) intensity scores (0-10 scale) at baseline to the mean of a three-day diary of NRS scores at 3 months comparing all participants randomized to CMM vs. PNS+CMM.

Time frame
Baseline to Month 3

Secondary outcomes

1

Trial Response Rate

Defined as 50% relief of average pain intensity comparing the mean of a three-day diary of NRS scores at baseline to the mean of a three-day diary of NRS scores at 15 days comparing participants randomized to CMM vs. PNS+CMM. This outcome will be assessed either 15 days after baseline assessments among participants randomized to CMM, 15 days after Nalu PNS trial lead placement, or 15 days after SPR Sprint PNS microlead placement.

Time frame
Baseline to 15 days

Other outcomes

Sponsors and contacts

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Stanford University

Lead sponsor

National Institutes of Health (NIH)

Collaborator

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborator

University of Kansas Medical Center

Collaborator

Source ClinicalTrials.gov
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