AzTrials
AzTrials

PainRELIEFNCT01719055

RELIEF - A Global Prospective Observational Post-Market Study to Evaluate Long-Term Effectiveness of Neurostimulation Therapy for Pain

An observational study of Pain, run by Boston Scientific Corporation at 118 sites in 16 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

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 Instructions for Use and - To evaluate the economic value and technical performance of Boston Scientific… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pain
What is being tested?
neurostimulation system
Type of treatment
Medical device
How many people
4,800 participants
Where
118 sitesin 16 countries
Study dates
19 Nov 2012to May 2035
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Subjects who exhibit an on-label indication for neurostimulation to relieve chronic intractable pain, according to the Instructions for Use, as applicable in each country or region

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

118 sites in 16 countries. Contact the study team or a site near you to ask about taking part.

118 sites in 16 countries

United States67 sites, 12 recruiting
  • Albany Medical Center

    Albany, New York, 12208

    Terminated
  • Michigan Pain Specialists

    Ann Arbor, Michigan, 48108

    Terminated
  • Balcones Pain Consultants

    Austin, Texas, 78745

    Terminated
  • Washington Center for Pain Management

    Bellevue, Washington, 98004

    Terminated
  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115

    Boston Scientific Clinical Research, 855-213-9890, BSNClinicalTrials@bsci.com

    Recruiting
  • Beth Israel Deaconess Medical Center

    Brookline, Massachusetts, 02445

    Terminated
  • Comprehensive Pain Management Center

    Campbell, California, 95008

    Terminated
  • Coastal Research Institute

    Carlsbad, California, 92009

    Terminated
  • Medical University of South Carolina

    Charleston, South Carolina, 29425

    Terminated
  • Midwest Pain Center

    Chesterfield, Missouri, 63005

    Terminated
  • Saint Louis Pain Consultants

    Chesterfield, Missouri, 63017

    Terminated
  • Northwestern Memorial Hospital - Neurosurgery Outpatient Clinic

    Chicago, Illinois, 60611

    Terminated
  • Chicago Anesthesia Pain Specialists

    Chicago, Illinois, 60657

    Terminated
  • Orlando Health Neuroscience Institute, Inc

    Clermont, Florida, 34711

    Boston Scientific Clinical Research, 855-213-9890, BSNClinicalTrials@bsci.com

    Recruiting
  • South Lake Pain Institute, Inc

    Clermont, Florida, 34711

    Boston Scientific Clinical Research Manager, 855-213-9890, BSNClinicalTrials@bsci.com

    Recruiting
  • Case Western Reserve University

    Cleveland, Ohio, 44106

    Completed
  • Ohio State University Medical Center

    Columbus, Ohio, 43203

    Terminated
  • Institute of Precision Pain Medicine

    Corpus Christi, Texas, 78414

    Boston Scientific Clinical Research, 855-213-9890, BSNClinicalTrials@bsci.com

    Recruiting
  • Neuroscience Associates of Northern Kentucky

    Crestview Hills, Kentucky, 41017

    Withdrawn
  • Bux Pain Management

    Danville, Kentucky, 40422

    Terminated
  • Pacific Sports and Spine, LLC

    Eugene, Oregon, 97401

    Boston Scientific Clinical Research Manager, 855-213-9890, BSNClinicalTrials@bsci.com

    Recruiting
  • Global Scientific Innovations - Advanced Pain Care Clinic

    Evansville, Indiana, 47714

    Terminated
  • Insight Institute of Neurosurgery & Neuroscience

    Flint, Michigan, 48507

    Terminated
  • Florence Neurosurgery and Spine

    Florence, South Carolina, 29506

    Terminated
  • Summit Research Institute

    Fort Wayne, Indiana, 46825

    Terminated
  • Pain Medicine Associates, Inc.

    Fountain Valley, California, 92708

    Terminated
  • University of Florida Shands Hospital

    Gainesville, Florida, 32608

    Boston Scientific Clinical Research Manager, 855-213-9890, BSNClinicalTrials@bsci.com

    Recruiting
  • Advanced Pain Management Appleton

    Greenfield, Wisconsin, 53221

    Terminated
  • PCPMG Clinical Research Unit, LLC

    Greenville, South Carolina, 29601

    Boston Scientific Clinical Research Manager, 855-213-9890, BSNClinicalTrials@bsci.com

    Recruiting
  • Goodman Campbell Brain and Spine

    Greenwood, Indiana, 46143

    Withdrawn
  • Denver Back Pain Specialists

    Greenwood Village, Colorado, 80111

    Boston Scientific Clinical Research, 855-213-9890, BSNClinicalTrials@bsci.com

    Recruiting
  • Carolinas Research Institute, PLLC

    Huntersville, North Carolina, 28078

    Terminated
  • Jackson Anesthesia Pain Center, LLC

    Jackson, Mississippi, 39202

    Terminated
  • Louis J. Raso, MD, PA

    Jupiter, Florida, 33477

    Terminated
  • EvergreenHealth Pain Care

    Kirkland, Washington, 98034

    Withdrawn
  • Hope Research Institute

    Las Vegas, Nevada, 89106

    Withdrawn
  • KC Pain Centers

    Lee's Summit, Missouri, 64086

    Terminated
  • Research Medical Center

    Lenexa, Kansas, 66214

    Terminated
  • Advanced Interventional Pain Management and Research Clinic, Inc.

    Miami Gardens, Florida, 33169

    Terminated
  • West Virginia University Hospitals

    Morgantown, West Virginia, 26506

    Withdrawn
  • American Health Network of Indiana, LLC

    Muncie, Indiana, 47304

    Terminated
  • Ochsner Clinic Foundation

    New Orleans, Louisiana, 70115

    Boston Scientific Clinical Research Manager, 855-213-9890, BSNClinicalTrials@bsci.com

    Recruiting
  • New York Presbyterian Hospital

    New York, New York, 10065

    Terminated
  • Spine Works Institute

    North Richland Hills, Texas, 76182

    Terminated
  • Channel Research

    Pawleys Island, South Carolina, 29585

    Terminated
  • Physicians Research Group, LLC

    Phoenix, Arizona, 85016

    Terminated
  • Hope Research Institute

    Phoenix, Arizona, 85018

    Terminated
  • Raleigh Neurology Associates, P.A.

    Raleigh, North Carolina, 27607

    Terminated
  • University of Rochester

    Rochester, New York, 14618

    Terminated
  • Spine Team Texas

    Rockwall, Texas, 75032

    Terminated
  • Metropolitan Pain Management Consultants Inc.

    Sacramento, California, 95821

    Terminated
  • Huntley Pain Specialists

    San Diego, California, 92108

    Withdrawn
  • Orthopedic Research Foundation

    Savannah, Georgia, 31405

    Terminated
  • Swedish Neuroscience Institute

    Seattle, Washington, 98122

    Terminated
  • Willis-Knighton River Cities Clinical Research Center

    Shreveport, Louisiana, 71105

    Boston Scientific Clinical Research Manager, 855-213-9890, BSNClinicalTrials@bsci.com

    Recruiting
  • JM Clinical Research

    South Miami, Florida, 33143

    Withdrawn
  • Pain Care, LLC

    Stockbridge, Georgia, 30281

    Withdrawn
  • Tallahassee Neurological Clinic, PA

    Tallahassee, Florida, 32308

    Terminated
  • Montefiore Medical Center

    The Bronx, New York, 10461

    Boston Scientific Clinical Research, 855-213-9890, BSNClinicalTrials@bsci.com

    Recruiting
  • Conejo Pain Specialists

    Thousand Oaks, California, 91362

    Terminated
  • University of Toledo Medical Center

    Toledo, Ohio, 43614

    Terminated
  • Fox Chase Pain Management

    Trevose, Pennsylvania, 19053

    Boston Scientific Clinical Research, 855-213-9890, BSNClinicalTrials@bsci.com

    Recruiting
  • Banner University Medical Center

    Tucson, Arizona, 85724

    Completed
  • Precision Spine Care

    Tyler, Texas, 75701

    Terminated
  • Spine and Skeletal Pain Medicine

    Utica, New York, 13502

    Terminated
  • The Center for Clinical Research, LLC

    Winston-Salem, North Carolina, 27103

    Terminated
  • Forest Health Medical Center

    Ypsilanti, Michigan, 48198

    Terminated

Other trials in United States

Spain10 sites, 4 recruiting
  • Hospital General de Ciudad Real

    Ciudad Real

    Boston Scientific Clinical Research, 855-213-9890, BSNClinicalTrials@bsci.com

    Recruiting
  • Hospital La Paz

    Madrid

    Terminated
  • Hospital La Princesa

    Madrid

    Terminated
  • Hospital Puerta de Hierro

    Madrid

    Boston Scientific Clinical Research, 855-213-9890, BSNClinicalTrials@bsci.com

    Recruiting
  • Hospital Universitario Infanta Elena

    Madrid

    Withdrawn
  • Clinica Universidad de Navarra

    Pamplona

    Boston Scientific Clinical Research, 855-213-9890, BSNClinicalTrials@bsci.com

    Recruiting
  • Hospital Donostia

    San Sebastián

    Active, not recruiting
  • H. Marques De Valdecilla

    Santander

    Terminated
  • Hospital Virgen De La Salud

    Toledo

    Terminated
  • Hospital General de Valencia

    Valencia

    Boston Scientific Clinical Research, 855-213-9890, BSNClinicalTrials@bsci.com

    Recruiting

Other trials in Spain

Australia8 sites, 1 recruiting
  • Interventus Pain Specialists

    Auchenflower

    Withdrawn
  • Hunter Clinical Research

    Broadmeadow

    Terminated
  • Hunter Pain Clinic

    Broadmeadow

    Terminated
  • Green Lizard Science

    Claremont

    Terminated
  • Sydney Spine and Pain Pty Ltd

    Hurstville

    Terminated
  • Sunshine Coast Clinical Research

    Noosa

    Terminated
  • Pain Matrix

    Waurn Ponds

    Terminated
  • Pain Medicine of South Australia

    Wayville

    Boston Scientific Clinical Research Manager, 855-213-9890, BSNClinicalTrials@bsci.com

    Recruiting

Other trials in Australia

United Kingdom7 sites, 5 recruiting
  • Basildon and Thurrock University Hospitals NHS

    Basildon

    Boston Scientific Clinical Research Manager, 855-213-9890, BSNClinicalTrials@bsci.com

    Recruiting
  • Southmead Hospital Bristol

    Bristol

    Boston Scientific Clinical Research Manager, 855-213-9890, BSNClinicalTrials@bsci.com

    Recruiting
  • The General Infirmary

    Leeds

    Boston Scientific Clinical Research, 855-213-9890, BSNClinicalTrials@bsci.com

    Recruiting
  • Chelsea and Westminster Hospital

    London

    Terminated
  • St. Bartholomews Hospital

    London

    Boston Scientific Clinical Research Manager, 855-213-9890, BSNClinicalTrials@bsci.com

    Recruiting
  • James Cook University Hospital

    Middlesbrough

    Boston Scientific Clinical Research, 855-213-9890, BSNClinicalTrials@bsci.com

    Recruiting
  • Royal National Orthopaedic Hospital

    Stanmore

    Terminated

Other trials in United Kingdom

Germany6 sites, 3 recruiting
  • Universitatsklinik Charite Berlin

    Berlin

    Boston Scientific Clinical Research, 855-213-9890, BSNClinicalTrials@bsci.com

    Recruiting
  • University KH Bonn

    Bonn

    Terminated
  • Uniklinik Köln

    Cologne

    Terminated
  • Uniklinik Köln

    Cologne

    Boston Scientific Clinical Research, 855-213-9890, BSNClinicalTrials@bsci.com

    Recruiting
  • Universitaetsklinikum Dusseldorf

    Düsseldorf

    Boston Scientific Clinical Research Manager, 855-213-9890, BSNClinicalTrials@bsci.com

    Recruiting
  • Algesiologikum

    München

    Terminated

Other trials in Germany

Japan4 sites
  • Kobe University Hospital

    Kobe

    Terminated
  • Hyogo College of Medicine Hospital

    Nishinomiya-shi

    Terminated
  • Okayama University Hospital

    Okayama

    Terminated
  • Sakai Hospital Kinki University Faculty of Medicine

    Sakaishi

    Terminated

Other trials in Japan

Canada3 sites, 2 recruiting
  • London Health Sciences Centre

    London

    Terminated
  • Hopital de Enfant-Jesus

    Québec

    Boston Scientific Clinical Research Manager, 855-213-9890, BSNClinicalTrials@bsci.com

    Recruiting
  • Regina General Hospital

    Regina

    Boston Scientific Clinical Research Manager, 855-213-9890, BSNClinicalTrials@bsci.com

    Recruiting

Other trials in Canada

Belgium2 sites
  • AZ Sint-Lucas

    Ghent

    Withdrawn
  • AZ Delta

    Roeselare

    Terminated

Other trials in Belgium

Colombia2 sites
  • Fundacion Clinica Valle del Lili

    Cali

    Withdrawn
  • Fundacion Cardiovascular de Colombia Floridablanca

    Floridablanca

    Terminated

Other trials in Colombia

Israel2 sites
  • Sheba Medical Center

    Ramat Gan

    Terminated
  • Tel Aviv Sourasky Medical Center

    Tel Aviv

    Terminated

Other trials in Israel

Italy2 sites, 1 recruiting
  • Fondazione Salvatore Maugeri IRCCS

    Pavia

    Boston Scientific Clinical Research Manager, 855-213-9890, BSNClinicalTrials@bsci.com

    Recruiting
  • Azienda Ospedaliero Universitaria Pisana

    Pisa

    Terminated

Other trials in Italy

Argentina1 site
  • CENIT Centro de Neurociencias, Investigacion y Tratamiento

    Buenos Aires

    Terminated

Other trials in Argentina

Denmark1 site
  • Odense University Hospital

    Odense

    Terminated

Other trials in Denmark

Netherlands1 site
  • Ziekenhuis Rijnstate

    Velp

    Terminated

Other trials in Netherlands

Sweden1 site
  • Sahlgrenska University Hospital

    Gothenburg

    Terminated

Other trials in Sweden

Switzerland1 site
  • Ospedale Regionale di Lugano

    Viganello

    Terminated

Other trials in Switzerland

About this study

Official title: A Global Prospective Observational Post-Market Study to Evaluate Long-Term Effectiveness of Neurostimulation Therapy for Pain

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 Instructions for Use

  • and -

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

Read the detailed description

The study is a prospective, multi-center, global, post-market study 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.

Conditions
Pain
Being tested
neurostimulation system
Keywords
stimulation, implantable, pulse generator, back pain, chronic pain, leg pain
Medical subject headings
Pain, Back Pain, Chronic Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • neurostimulation systemDevice

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

Study groups in NCT01719055
Study groupRoleWhat they receive
Boston Scientific SCS SystemsSubjects permanently implanted with a Boston Scientific neurostimulation systems
Receives: Device: neurostimulation system

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Nov 2012 (estimated)
  2. Study start19 Nov 2012
  3. Primary completionMay 2035 (estimated)
  4. Study completionMay 2035 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
4,800 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01719055
Sponsor's protocol ID
A7007
Other IDs
90876777
Acronym
RELIEF
Status last verified
Oct 2026
First submitted
30 Oct 2012
Last updated
13 Oct 2026
Results posted
No
Data monitoring committee
No

Publications

  • Rauck RL, Loudermilk E, Thomson SJ, Paz-Solis JF, Bojrab L, Noles J, Vesper J, Atallah J, Roth D, Hegarty J, Prud'Homme M, Phillips GM, Smith SG, Ibrahim M, Willoughby CD, Obray JB, Gupta M, Paez J, Berg AP, Harrison NJ, Maino P, Mambalam P, McCarty M, Towlerton G, Love-Jones S, Ahmed S, Lee A, Shah B, Goor-Aryeh I, Russo MA, Varela N, Phelps JB, Cid J, Fernandez T, Perez-Hernandez C, Keehn D, Rosenow JM, Haider N, Parrent AG, Lawrence MM, Georgius P, Demartini L, Mendiola A, Mehta V, Thoma R, Israel AF, Carolis G, Bhatia S, Green M, Villarreal A, Crooks MT, Gwinn RP, Pilitsis JG, Sato H, Vega SM, Hillegass MG, Carnes P, Scherer C, Brill S, Yu J, Brennan JJ, Gatzinsky K, Navani A, Snook LT Jr, Bujedo BM, Andres Ares J, Murillo A, Trobridge AT, Assil K, Shah J, McLeod C, Buwembo J, Coster O, Miller N, Sanapati M, Mikhael M, Przkora R, Sukenaga N, Raso LJ, Calodney AK, Caceres Jerez LE, Uchiyama T, Kallewaard JW, Chandler B, Piedimonte F, Candido KD, Weaver TE, Agari T, Holthouse D, Woon R, Patel N, Lechleiter K, Jain R. Long-term safety of spinal cord stimulation systems in a prospective, global registry of patients with chronic pain. Pain Manag. 2023 Feb;13(2):115-127. doi: 10.2217/pmt-2022-0091. Epub 2023 Jan 24.

    PubMed 36691862

Questions about this trial

What is this clinical trial studying?

An observational study of Pain, run by Boston Scientific Corporation at 118 sites in 16 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 118 sites in United States, Spain, Australia, United Kingdom, Germany and 11 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Thanh Hoang, MS (855-213-9890, BSNClinicalTrials@bsci.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01719055, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026; AzTrials last refreshed its copy on 31 Oct 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in