RELIEF - A Global Registry to Evaluate Long-Term Effectiveness of Neurostimulation Therapy for Pain

Pain Clinical Trial

— RELIEF  

Official title:

A Global Registry to Evaluate Long-Term Effectiveness of Neurostimulation Therapy for Pain

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01719055
• Other study ID #: A7007
• Secondary ID: 90876777
• Status: Recruiting
• Start date: November 19, 2012
• Est. completion date: October 2027

Study information

• Verified date: June 2024
• Source: Boston Scientific Corporation
• Contact: Gerard Herro, MS
• Phone: 855-213-9890
• Email: BSNClinicalTrials[@]bsci.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

To compile characteristics of real-world clinical outcomes for Boston Scientific commercially approved neurostimulation systems for pain in routine clinical practice, when used according to the applicable Directions for Use

• and -

To evaluate the economic value and technical performance of Boston Scientific commercially approved neurostimulation systems for pain in routine clinical practice

Description:

The study is a prospective, multi-center, global registry of Boston Scientific neurostimulation systems for pain.

The study treatment will consist of neurostimulation trial therapy with any commercially approved Boston Scientific Corporation neurostimulator for pain. Positive trials, subjects with a successful trial outcome, may progress to permanent implant of a neurostimulation system. Individualization of neurostimulation therapy for pain will be determined according to investigator discretion and site routine care, and in accordance with inclusion and exclusion criteria.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 4800
• Est. completion date: October 2027
• Est. primary completion date: October 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Key Inclusion Criteria:

• Study candidate is scheduled to be trialed, on-label, with a commercially approved Boston Scientific neurostimulation system for pain, per local directions for use

• Signed a valid, IRB/EC-approved informed consent form

• 18 years of age or older

Key Exclusion Criteria:

• Contraindicated for Boston Scientific neurostimulation system

• Currently diagnosed with cognitive impairment, or exhibits any characteristic, that would limit study candidate's ability to assess pain relief or to complete study assessments

Related Conditions & MeSH terms

• Pain

Intervention

Device:
• neurostimulation system
Trial stimulation period, followed by permanent implant of a neurostimulation system for subjects with a positive trial outcome

Locations

Country	Name	City	State
Argentina	CENIT Centro de Neurociencias, Investigacion y Tratamiento	Ciudad Autonoma de Buenos Aires
Australia	Interventus Pain Specialists	Auchenflower
Australia	Hunter Clinical Research	Broadmeadow
Australia	Hunter Pain Clinic	Broadmeadow
Australia	Green Lizard Science	Claremont
Australia	Sydney Spine and Pain Pty Ltd	Hurstville
Australia	Sunshine Coast Clinical Research	Noosa Heads
Australia	Pain Matrix	Waurn Ponds
Australia	Pain Medicine of South Australia	Wayville
Belgium	AZ Sint-Lucas	Gent
Belgium	AZ Delta	Roeselare
Canada	London Health Sciences Centre	London
Canada	Hopital de Enfant-Jesus	Québec
Canada	Regina General Hospital	Regina
Colombia	Fundacion Clinica Valle del Lili	Cali
Colombia	Fundacion Cardiovascular de Colombia Floridablanca	Floridablanca
Denmark	Odense University Hospital	Odense
Germany	Universitatsklinik Charite Berlin	Berlin
Germany	University KH Bonn	Bonn
Germany	Universitaetsklinikum Dusseldorf	Duesseldorf
Germany	Uniklinik Köln	Koeln
Germany	Uniklinik Köln	Köln
Germany	Algesiologikum	München
Israel	Sheba Medical Center	Ramat-Gan
Israel	Tel Aviv Sourasky Medical Center	Tel Aviv
Italy	Fondazione Salvatore Maugeri IRCCS	Pavia
Italy	Azienda Ospedaliero Universitaria Pisana	Pisa
Japan	Kobe University Hospital	Kobe-shi
Japan	Hyogo College of Medicine Hospital	Nishinomiya-shi
Japan	Okayama University Hospital	Okayama-shi
Japan	Sakai Hospital Kinki University Faculty of Medicine	Sakai-shi
Netherlands	Ziekenhuis Rijnstate	Velp
Spain	Hospital General de Ciudad Real	Ciudad Real
Spain	Hospital La Paz	Madrid
Spain	Hospital La Princesa	Madrid
Spain	Hospital Puerta de Hierro	Madrid
Spain	Hospital Universitario Infanta Elena	Madrid
Spain	Clinica Universidad de Navarra	Pamplona
Spain	Hospital Donostia	San Sebastián
Spain	H. Marques De Valdecilla	Santander
Spain	Hospital Virgen De La Salud	Toledo
Spain	Hospital General de Valencia	Valencia
Sweden	Sahlgrenska University Hospital	Göteborg
Switzerland	Ospedale Regionale di Lugano	Viganello
United Kingdom	Basildon and Thurrock University Hospitals NHS	Basildon
United Kingdom	Southmead Hospital Bristol	Bristol
United Kingdom	The General Infirmary	Leeds
United Kingdom	Chelsea and Westminster Hospital	London
United Kingdom	St. Bartholomews Hospital	London
United Kingdom	Royal National Orthopaedic Hospital	Stanmore
United States	Albany Medical Center	Albany	New York
United States	Balcones Pain Consultants	Austin	Texas
United States	Washington Center for Pain Management	Bellevue	Washington
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	Beth Israel Deaconess Medical Center	Brookline	Massachusetts
United States	Comprehensive Pain Management Center	Campbell	California
United States	Coastal Research Institute	Carlsbad	California
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Midwest Pain Center	Chesterfield	Missouri
United States	Saint Louis Pain Consultants	Chesterfield	Missouri
United States	Chicago Anesthesia Pain Specialists	Chicago	Illinois
United States	Northwestern Memorial Hospital - Neurosurgery Outpatient Clinic	Chicago	Illinois
United States	South Lake Pain Institute, Inc	Clermont	Florida
United States	Case Western Reserve University	Cleveland	Ohio
United States	Ohio State University Medical Center	Columbus	Ohio
United States	Neuroscience Associates of Northern Kentucky	Crestview Hills	Kentucky
United States	Bux Pain Management	Danville	Kentucky
United States	Pacific Sports and Spine, LLC	Eugene	Oregon
United States	Global Scientific Innovations - Advanced Pain Care Clinic	Evansville	Indiana
United States	Insight Institute of Neurosurgery & Neuroscience	Flint	Michigan
United States	Florence Neurosurgery and Spine	Florence	South Carolina
United States	Summit Research Institute	Fort Wayne	Indiana
United States	Pain Medicine Associates, Inc.	Fountain Valley	California
United States	University of Florida Shands Hospital	Gainesville	Florida
United States	Advanced Pain Management Appleton	Greenfield	Wisconsin
United States	PCPMG Clinical Research Unit, LLC	Greenville	South Carolina
United States	Goodman Campbell Brain and Spine	Greenwood	Indiana
United States	Carolinas Research Institute, PLLC	Huntersville	North Carolina
United States	Jackson Anesthesia Pain Center, LLC	Jackson	Mississippi
United States	Louis J. Raso, MD, PA	Jupiter	Florida
United States	EvergreenHealth Pain Care	Kirkland	Washington
United States	Hope Research Institute	Las Vegas	Nevada
United States	KC Pain Centers	Lee's Summit	Missouri
United States	Research Medical Center	Lenexa	Kansas
United States	Advanced Interventional Pain Management and Research Clinic, Inc.	Miami Gardens	Florida
United States	West Virginia University Hospitals	Morgantown	West Virginia
United States	American Health Network of Indiana, LLC	Muncie	Indiana
United States	Ochsner Clinic Foundation	New Orleans	Louisiana
United States	New York Presbyterian Hospital	New York	New York
United States	Spine Works Institute	North Richland Hills	Texas
United States	Channel Research	Pawleys Island	South Carolina
United States	Hope Research Institute	Phoenix	Arizona
United States	Physicians Research Group, LLC	Phoenix	Arizona
United States	Raleigh Neurology Associates, P.A.	Raleigh	North Carolina
United States	University of Rochester	Rochester	New York
United States	Spine Team Texas	Rockwall	Texas
United States	Metropolitan Pain Management Consultants Inc.	Sacramento	California
United States	Huntley Pain Specialists	San Diego	California
United States	Orthopedic Research Foundation	Savannah	Georgia
United States	Swedish Neuroscience Institute	Seattle	Washington
United States	Willis-Knighton River Cities Clinical Research Center	Shreveport	Louisiana
United States	JM Clinical Research	South Miami	Florida
United States	Pain Care, LLC	Stockbridge	Georgia
United States	Tallahassee Neurological Clinic, PA	Tallahassee	Florida
United States	Conejo Pain Specialists	Thousand Oaks	California
United States	University of Toledo Medical Center	Toledo	Ohio
United States	Banner University Medical Center	Tucson	Arizona
United States	Precision Spine Care	Tyler	Texas
United States	Spine and Skeletal Pain Medicine	Utica	New York
United States	The Center for Clinical Research, LLC	Winston-Salem	North Carolina
United States	Forest Health Medical Center	Ypsilanti	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Boston Scientific Corporation

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Belgium,  Canada,  Colombia,  Denmark,  Germany,  Israel,  Italy,  Japan,  Netherlands,  Spain,  Sweden,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Percent pain relief	Percent pain relief of targeted pain at 6, 12, 24 and 36 months follow up	up to 36 months follow up
Other	Percent pain relief	Percent pain relief of low back pain at 6, 12, 24 and 36 months follow up	up to 36 months follow up
Other	Percent pain relief	Percent pain relief of leg pain at 6, 12, 24 and 36 months follow up	up to 36 months follow up
Other	Change in QoL	Change in quality of life as reported by the Subject at 6, 12, 24 and 36 months follow up	up to 36 months follow up