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This post market study is being conducted to document the comparative effectiveness and safety of peripheral nerve stimulation plus conventional medical management versus conventional medical management alone in the treatment of chronic, intractable peripheral neuralgia of post-traumatic or post-surgical origin. This is a prospective, minimal risk, multi-center, randomized control trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PNS Therapy plus Conventional Medical Management | Active Comparator | peripheral nerve stimulator plus conventional medical management |
|
| Conventional Medical Management | Other | Control arm conventional medical management only |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nalu Neurostimulation System for PNS | Device | The Nalu Neurostimulation System for PNS is a peripheral nerve stimulator |
|
| Measure | Description | Time Frame |
|---|---|---|
| Effectiveness: Responder rates between groups | Difference in responder rates between groups. Responder rate is defined as the percent of subjects with 50% or greater pain relief from baseline, based on the BPI-Q5 (NRS). | 3-months |
| Safety: Rate of serious and non-serious adverse events between groups | Rate of serious and non-serious adverse events between groups | 3-months |
| Measure | Description | Time Frame |
|---|---|---|
| Responder Rates between groups at 6-months | Difference in responder rates between groups. Responder rate is defined as the percent of subjects with 50% or greater pain relief from baseline, based on the BPI-Q5 (NRS). | 6 months |
| Responder Rates between groups at 12-months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Patrick Martin | Nalu Medical | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arizona Pain Specialists | Scottsdale | Arizona | 85258 | United States | ||
| University of Arkansas Interventional Spine and Pain Clinic |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39572166 | Derived | Hatheway J, Hersel A, Engle M, Gutierrez G, Khemlani V, Kapural L, Moore G, Ajakwe R, Trainor D, Hah J, Staats PS, Makous J, Heit G, Kottalgi S, Desai MJ; COMFORT Study Group. Clinical study of a micro-implantable pulse generator for the treatment of peripheral neuropathic pain: 12-month results from the COMFORT-randomized controlled trial. Reg Anesth Pain Med. 2026 Mar 5;51(3):278-284. doi: 10.1136/rapm-2024-106099. |
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|
| conventional medical management | Other | Conventional medical management |
|
Difference in responder rates between groups. Responder rate is defined as the percent of subjects with 50% or greater pain relief from baseline, based on the BPI-Q5 (NRS). |
| 12-months |
| Responder Rates between groups at 24-months | Difference in responder rates between groups. Responder rate is defined as the percent of subjects with 50% or greater pain relief from baseline, based on the BPI-Q5 (NRS). | 24-months |
| Responder Rates between groups at 36-months | Difference in responder rates between groups. Responder rate is defined as the percent of subjects with 50% or greater pain relief from baseline, based on the BPI-Q5 (NRS). | 36-months |
| Functional Outcomes: Change in ODI, BDI, EQ-5D, BPI from baseline | Change in patient reported outcomes from baseline between groups | 3, 6, 9, 12, 18, 24, 30 and 36 months |
| Safety Assessment | Rate of serious and non-serious events | 3, 6, 9, 12, 18, 24, 30 and 36 months |
| Little Rock |
| Arkansas |
| 72205 |
| United States |
| Comprehensive Spine & Pain Physicians | Burbank | California | 91505 | United States |
| Stanford University Pain Management Center | Redwood City | California | 94063 | United States |
| Pain Management and Injury Relief | Thousand Oaks | California | 91320 | United States |
| DBPS Research LLC | Denver | Colorado | 80111 | United States |
| International Spine, Pain & Performance Center | Washington D.C. | District of Columbia | 20006 | United States |
| The Center for Clinical Research | Winston-Salem | North Carolina | 27103 | United States |
| Pacific Sports and Spine | Eugene | Oregon | 97401 | United States |
| Columbia Pain Management | Milwaukie | Oregon | 97222 | United States |
| Pain Specialists of America | Austin | Texas | 78745 | United States |
| Institute of Precision Pain Medicine | Corpus Christi | Texas | 78414 | United States |
| Anesis Spine and Pain Care | Spokane | Washington | 99216 | United States |
| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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