Mechanisms of Stimulation for Pain Alleviation (NCT06741579) | Clinical Trial Compass
RecruitingPhase 3
Mechanisms of Stimulation for Pain Alleviation
United States148 participantsStarted 2025-09-26
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria 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 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
Williness to refrain from physical activity for at least 7 days post-leaā¦
What they're measuring
1
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)