Mechanisms of Stimulation for Pain Alleviation

Launched by STANFORD UNIVERSITY · Dec 17, 2024

Keywords

ClinConnect Summary

The clinical trial titled "Mechanisms of Stimulation for Pain Alleviation" is designed to study a new treatment approach for people suffering from chronic neuropathic pain in their lower back and legs. The trial will involve 134 participants who will be divided into two groups: one will continue with their standard pain management, while the other will receive additional therapy called peripheral nerve stimulation (PNS) along with their usual care. This trial aims to understand how these treatments work and how different factors, like a person's pain sensitivity and mental health, affect treatment outcomes.

To be eligible for the trial, participants must be at least 18 years old and have a specific type of nerve pain that has lasted for at least six months. They should have already been referred for a PNS implant and experienced significant pain relief from prior nerve block injections. Throughout the study, participants will undergo regular assessments and tests to track their pain levels and overall health. The trial has not yet started recruiting participants, but it will provide valuable insights into how PNS and conventional treatments can help manage chronic pain more effectively.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Adults aged 18 or older with clinically diagnosed unilateral lower extremity CNP 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). 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 implant, 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.
• • Stable dosage of analgesic medications for at least 30 days, and willingness to refrain from trialing new analgesic medications for three months after randomization
• • Worst pain intensity of ≥5/10 on the Numeric Rating Scale (NRS) of Pain (0-10) at the lower extremity CNP-PI site at enrollment •Worst pain intensity of \<5/10 on the NRS elsewhere over the entire body
• • Fluent in English writing, reading, and speaking
• • Ability and willingness to complete online assessments
• • Willingness to refrain from physical activity or exercise causing muscle and/or joint soreness for 48 hours prior to QST, pain medications (e.g., NSAIDs, acetaminophen, opioids) for 12 hours prior to QST, and alcohol and nicotine on the day of QST\*
• Exclusion Criteria:
• • Unable to tolerate wearing external Therapy Disk with relief belt/adhesive clip in the planned location of the IPG
• • Conditions causing inability to complete assessments (education, cognitive ability, mental status, medical status)
• • 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 lower extremity 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
• • Current, recent (within the last 6 months), or habitual use of artificial nails or nail enhancements. (Artificial nails can influence pressure pain sensitivity at the thumbnail)\*
• • 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\*