Nerivio Device for Chronic Pain

(Nerivio Trial)

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Children's Health

Must not be taking: Psychotropic medications

Disqualifiers: Autoimmune, Neurological, Mood disorders, others

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a wearable device called the Nerivio®, designed to help manage Amplified Musculoskeletal Pain Syndrome (AMPS) in children. The device activates nerves in the upper arm, which can reduce pain and improve quality of life. Participants will be divided into two groups: one will use the Nerivio® device every other day, while the other will continue with their usual pain treatments. This study suits children aged 8 to 18 who have experienced chronic musculoskeletal pain for at least three months and can use a smartphone app. As an unphased trial, this study offers a unique opportunity for participants to contribute to innovative research that could enhance pain management for children.

What prior data suggests that the Nerivio® device is safe for children with AMPS?

Research has shown that the Nerivio device is generally safe. In studies, it consistently proved safe and effective for treating migraines over a year. Only one out of 99 participants experienced a device-related issue, specifically arm pain after use. This suggests that most people tolerate the device well. While the device's safety for chronic migraines isn't fully confirmed, its positive track record in other situations offers some reassurance for managing pain. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Nerivio device is unique because it offers a non-drug, wearable approach to managing chronic pain, unlike traditional treatments like medications or physical therapy. This device uses remote electrical neuromodulation, which means it sends electrical signals to the brain to alter how pain is processed, potentially reducing pain without the side effects commonly associated with medication. Researchers are excited about its potential to provide a convenient, side-effect-free option for pain relief that patients can use at home every 48 hours.

What evidence suggests that the Nerivio® device is effective for treating Amplified Musculoskeletal Pain Syndrome?

Research has shown that the Nerivio® device is promising for pain relief, particularly for migraines. One study found that 71% of users experienced pain relief two hours after using the device, and 35% were completely pain-free. This relief lasted up to 24 hours. The device has also proven effective over time, consistently helping both young people and adults. In this trial, participants in the experimental group will use the Nerivio® device to explore its potential benefits for Amplified Musculoskeletal Pain Syndrome (AMPS). Although limited data exists on its use for AMPS, the device's ability to activate nerves and relieve pain might benefit children with AMPS. ^{4 5 6 7 8}

Are You a Good Fit for This Trial?

This trial is for children aged 8-18 with Amplified Musculoskeletal Pain Syndrome (AMPS). It's designed to see if the Nerivio® device, which activates nerves in the arm to potentially ease pain, can help manage their condition better than usual treatments like medication and physical therapy.

Inclusion Criteria

Able to comprehend and follow instructions for the device use

Access to compatible smartphone or device to operate the Nerivio app

My child's pain condition was diagnosed by a pediatric pain specialist.

Exclusion Criteria

Use of implantable electronic medical devices

Active autoimmune disease

Neurological disorders that impair study participation as determined by the enrolling provider

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants in the intervention group use the Nerivio® device every other day, while the control group uses their usual pain control methods

4 weeks

Weekly questionnaires

Follow-up

Participants are monitored for safety, effectiveness, and satisfaction after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Nerivio(R) Device

Trial Overview The study tests the effectiveness of the Nerivio® device against standard AMPS care. Participants are split into two groups: one uses their regular pain management methods, while the other uses Nerivio® every other day alongside a smartphone app, with both groups reporting on pain and quality of life.

How Is the Trial Designed?

Group I: Intervention group Experimental Treatment 1 Intervention

Patients in the experimental group will use the Nerivio(R) device once every 48 hours.

Group II: Control group Placebo Group 1 Intervention

Patients with AMPS in the control group will use their usual practices to control pain.

Who Is Running the Clinical Trial?

Children's Health

Lead Sponsor

Trials

8

Recruited

460+

Theranica

Industry Sponsor

Trials

21

Recruited

41,700+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37855973/

One-Year Consistent Safety, Utilization, and Efficacy ... REN is a safe and well-tolerated acute migraine treatment, with stable efficacy and utilization over 1 year, making it an advantageous non-drug option.

2. nerivio.com nerivio.com/clinical-trials/efficacy-and-safety-of-nerivio

Nerivio USA Pain relief at 2 hours post-treatment (in the test treatment), 59.3% (54/91). Pain-free at 2 hours post-treatment (in the test treatment), 20.9% (19/91).

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06738056

Nerivio Long-term Usage in Patients With Migraine Consistent effectiveness - Stable pain relief, freedom from pain, functional disability relief ... efficacy of the Nerivio device using a real-world dataset.

4. nerivio.com nerivio.com/news-press/theranica-announces-results-from-pivotal-study-of-device-for-treating-acute-migraine

Theranica Announces Results from Pivotal Study of Device ... At two hours post treatment, 71% of participants reported pain relief and 35% reported pain freedom. Pain relief and pain freedom were sustained for 24 hours in ...

5. neurologylive.com neurologylive.com/view/nerivio-ren-wearable-delivers-consistent-drug-free-relief-over-three-years-study-shows

Nerivio REN Wearable Delivers Consistent Drug-Free ... In the study, both youth and adult participants maintained stable therapeutic outcomes, with pain relief consistently reported by 72% and 77% of ...

6. nerivio.com nerivio.com/clinical-trials/real-world-evidence-rwe-data-analysis-of-1-year-consecutive-use-of-nerivio-nct05760638

One-Year Consistent Safety, Utilization, and Efficacy ... Nerivio provides a safe, efficacious, and stable treatment over 1 year of consecutive use. Consistent Headache Relief at 2 Hours Post-treatment:

7. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/reviews/DEN180059.pdf

DEN180059.pdf - accessdata.fda.gov The safety and effectiveness of the device has not been demonstrated for subjects with chronic migraine.

8. clinicaltrials.gov clinicaltrials.gov/study/NCT07249931?locStr=United+States&country=United+States

Efficacy and Safety of Nerivio for the Management ... Efficacy and Safety of Nerivio for the Management of Amplified Musculoskeletal Pain Syndrome in Pediatric Patients. These data include ...