Prospective Evaluation of RINCE to Reduce Fibromyalgia Effects - 301
Public ClinicalTrials.gov record NCT02211508. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Double-Blinded, Randomized, Sham-Controlled, Pivotal Study of the NeuroPoint Device for the Treatment of Pain Associated With Fibromyalgia
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this study is to test the safety and efficacy of a noninvasive cortical electrostimulation therapy known as "Reduced Impedance Noninvasive Cortical Electrostimulation" (RINCE) in the treatment of pain associated with fibromyalgia. Patients who meet the 2010 American College of Rheumatology criteria for fibromyalgia will receive up to 24 RINCE treatments delivered by a medical device called "NeuroPoint". Approximately 200 fibromyalgia patients will be randomized into one of two study groups. One of these groups will receive sham treatment, meaning they will receive no treatment at all, while the other group will receive active RINCE treatment. The study's primary outcome measure will be the difference between active and sham treatment groups in the mean change from baseline in patients' weekly worst pain scores. The study's hypothesis is that there will be a difference between treatment groups in primary outcome measure.
Study identification
- NCT ID
- NCT02211508
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 236 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 22 Years to 65 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 2014 (Type not available)
- Primary completion
- Feb 2015 (Actual)
- Completion
- Feb 2015 (Actual)
- Last update posted
- Aug 9, 2016
2014 – 2015
United States locations
- U.S. sites
- 16
- U.S. states
- 12
- U.S. cities
- 16
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Achieve Clinical Research, LLC | Birmingham | Alabama | 35216 | — |
| Premier Research | Phoenix | Arizona | 85027 | — |
| Neurovations | Napa | California | 94558 | — |
| Superior Research LLC | Sacramento | California | 95825 | — |
| Artemis Institute for Clinical Research | San Diego | California | 92103 | — |
| Avail Clinical Research | DeLand | Florida | 32720 | — |
| Compass Research LLC | Orlando | Florida | 32806 | — |
| Chicago Research Center | Chicago | Illinois | 60634 | — |
| Michigan Head Pain & Neurological Institute | Ann Arbor | Michigan | 48104 | — |
| Fieve Clinical Research | New York | New York | 10168 | — |
| Upstate Clinical Research Associates | Williamsville | New York | 14221 | — |
| University of Cincinnati College of Medicine | Cincinnati | Ohio | 45219 | — |
| Sunstone Medical Research | Medford | Oregon | 97504 | — |
| Omega Medical Research | Warwick | Rhode Island | 02886 | — |
| Fatigue Consultation Clinic | Salt Lake City | Utah | 84102 | — |
| Swedish Clinical Research | Seattle | Washington | 98122 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02211508, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 9, 2016 · Synced Oct 27, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02211508 live on ClinicalTrials.gov.