Mechanisms of Stimulation for Pain Alleviation
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Chronic Neuropathic Pain in the Low Back and Legs
- Sponsor
- Stanford University
- Enrollment
- 148
- Locations
- 1
- Primary Endpoint
- Treatment Response: defined as 50% relief of average pain intensity at the area of lower back, pelvic, or lower extremity CNP. We will compare the means of a three-day diary of numeric rating scale of pain (NRS) intensity scores (0-10 scale)
- Status
- Recruiting
- Last Updated
- 7 months ago
Overview
Brief Summary
This is a mechanistic randomized controlled trial of patients with chronic neuropathic pain (CNP) in the 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.
Investigators
Jennifer Hah
Associate Professor of Anesthesiology, Perioperative and Pain Medicine (Adult Pain)
Stanford University
Eligibility Criteria
Inclusion Criteria
- Not provided
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
Outcomes
Primary Outcomes
Treatment Response: defined as 50% relief of average pain intensity at the area of lower back, pelvic, or lower extremity CNP. We will compare the means of a three-day diary of numeric rating scale of pain (NRS) intensity scores (0-10 scale)
Time Frame: 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 Outcomes
- Trial Response Rate(Baseline to 15 days)