Chronic Neuropathic Pain, Chronic Neuropathic Pain (Below the Shoulders), Peripheral Nerve Stimulation
Conditions
Keywords
SPRINT PNS, NALU PNS, Peripheral Nerve Stimulation
Brief summary
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.
Interventions
DEVICEPeripheral Nerve Stimulation
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.
PROCEDUREConventional Care Regimen
CMM-Only participants will receive conventional medical management for the duration of their time in the study.
Sponsors
Stanford University
National Institutes of Health (NIH)
National Institute of Neurological Disorders and Stroke (NINDS)
University of Kansas Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
for study participants Adults aged 18 or older with clinically diagnosed unilateral CNP in the upper extremities, lower back, pelvis, or lower extremities, defined (per IASP classification) as persistent or recurrent neuropathic pain caused by a peripheral nerve lesion, history of a plausible nerve trauma, pain onset in temporal relation to the trauma, and pain distribution within the innervation territory of a peripheral nerve (or nerves).14 Negative and positive sensory symptoms or signs must be compatible with the innervation territory of the affected nerve. Can be post-traumatic, post-surgical, nerve compression, nerve ischemia, peripheral nerve injury, painful scar, nerve entrapment, mononeuropathy with or without loss of motor function Patients enrolled in this study must already have been referred for or have an existing order for PNS therapy (either Nalu or SPR SPRINT), prior to consent and enrollment in this study, as part of their routine medical care. Patients cannot receive a referral for PNS device as part of the study procedures. Positive response (at least 50% pain relief) to diagnostic nerve block(s) at the suspected site(s) of CNP. Chronic (at least 6 months duration), intractable peripheral neuropathic pain; any nociceptive pain must be less prominent than the neuropathic pian. Fluent in English writing, reading, and speaking Ability and willingness to complete online assessments Willingness to refrain from physical activity for at least 7 days post-lead placement. Willingness to refrain from physical activity or exercise causing muscle and/or joint soreness for 48 hours prior to QST, illicit drugs (marijuana) for 12 hours, as-needed (PRN) pain medications (e.g., NSAIDs, acetaminophen, opioids) for 12 hours prior to QST, and alcohol and nicotine on the day of QST prior to testing\*
Exclusion criteria
Conditions causing inability to complete assessments (education, cognitive ability, mental status, medical status) Active cancer diagnosis, active malignant neoplasm (metastatic or local) or evidence of paraneoplastic syndrome Painful polyneuropathy (e.g., metabolic, autoimmune, familial, infectious disease, environmental toxins, treatment with neurotoxic drug) Chronic central neuropathic pain (e.g., spinal cord injury, brain injury, multiple sclerosis) Peripheral vascular disease Diabetic neuropathy Another pain diagnosis affecting the CNP site that could interfere with study procedures, accurate reporting and/or could confound evaluation of study endpoints (e.g., post-herpetic neuralgia) Other active implantable devices (e.g., implantable cardioverter defibrillator, spinal cord stimulator, dorsal root ganglion stimulator, sacral nerve stimulator, deep brain stimulator, intrathecal pump) Pregnancy, breastfeeding, or planning to conceive Systemic infection or local infection at the anticipated PNS implant site Immunocompromised state Coagulation disorder, bleeding diathesis, platelet dysfunction, active anticoagulation Interventional procedure and/or surgery to treat CNP in the last 30 days (subjects should be enrolled 30 days after last procedure, for prior ablative treatment must be enrolled at least 3 months after last procedure) Untreated substance use disorder Participating in another clinical trial with an active treatment arm Numbness or loss of sensation at the bilateral thumbnails, peripheral neuropathy in the hands, circulatory or sensory problem in the hands\* Participants with a history of Raynaud's Syndrome\* Participants with SBP ≥150 and/or DBP ≥100\* \*QST Inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | Baseline to Month 3 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Trial Response Rate | Baseline to 15 days | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORJennifer Hah, MD, MS.
Stanford University
PRINCIPAL_INVESTIGATORAndrea Chadwick, M.D., MSc, FASA
University of Kansas Medical Center
Outcome results
None listed