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New treatment option for Chronic Neuropathic Pain in the Low Back and Legs
Official title Mechanisms of Stimulation for Pain Alleviation
ClinicalTrials.gov ID: NCT06741579
What this study is testing
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- for study participants
- Adults aged 18 or older with clinically diagnosed unilateral CNP in the lower back, pelvis, or lower extremities, defined (per IASP classification)...
- 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...
- 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.
You likely can't join if
- 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
See the full eligibility criteria
Who can join
- for study participants
- Adults aged 18 or older with clinically diagnosed unilateral CNP in the lower back, pelvis, or lower extremities, defined (per IASP classification) as persistent or recurrent neuropathic pain caused by a peripheral...
- 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...
- 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
- Williness 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...
What rules you out
- 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
- treatment procedure and/or surgery to treat CNP in the last 30 days (people 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/Exclusion Criteria. Participants can still be enrolled iif they have the QST-only exclusionary criteria have the QST-only exclusionary criteria, but QST will be modified based on responses
- Additional Exclusion Criteria for people receiving PET/MRI and PET/CT imaging at Stanford:
- Prior radiation exposure of \>2 rem total within the last 12 months
- Standard contraindications that would preclude MRI including pacemakers or other electronic implants, metal foreign objects or fragments in the eye or body, and aneurysm clips.
- Claustrophobia
- Inability to understand and communicate with the investigators to complete the study related questionnaires
- Females with positive pregnancy test.
The study team makes the final eligibility decision.
Where it's taking place
- Palo Alto, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Palo Alto, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.