Patient Retrospective Outcomes (PRO)
Sponsor
Boston Scientific Corporation (Industry)
Overall Status
Recruiting
CT.gov ID
NCT01550575
Collaborator
(none)
10,000
107
187.9
93.5
0.5
Study Details
Study Description
Brief Summary
This study will evaluate de-identified (anonymous) data in subject medical charts to review the clinical outcomes of various treatment approaches in the treatment of chronic pain.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
This study is a retrospective, multi-center, de-identified patient data review.
The study will include multiple independent cohorts to evaluate clinical outcomes in different subgroups.
Study Design
Study Type:
Observational
Anticipated Enrollment
:
10000 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Patient Retrospective Outcomes (PRO)
Actual Study Start Date
:
Apr 3, 2012
Anticipated Primary Completion Date
:
Dec 1, 2027
Anticipated Study Completion Date
:
Dec 1, 2027
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Patients eligible for SCS, RF or other treatment approaches Patients who have previously been implanted with, or are eligible for implantation with a spinal cord stimulation system or various other treatment approaches such as RF, IDS, etc. |
Device: Non Boston Scientific Systems
Spinal cord stimulation, RF, IDS etc.
Device: Boston Scientific Systems
Spinal cord stimulation, RF, IDS etc
|
| Patients Eligible for treatment options with prior treatment Patients who have previously been implanted with a spinal cord stimulation system or other various treatments, and have thereafter received a different form of chronic pain treatment such as a different SCS system, RF, IDS etc. |
Device: Non Boston Scientific Systems
Spinal cord stimulation, RF, IDS etc.
Device: Boston Scientific Systems
Spinal cord stimulation, RF, IDS etc
|
Outcome Measures
Primary Outcome Measures
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Key Inclusion Criteria:
-
Previously treated with or eligible for use with Boston Scientific Systems
-
18 years of age or older at the start of Baseline
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hope Research Institute | Phoenix | Arizona | United States | 85018 |
| 2 | Kern Neuroscience Institute | Bakersfield | California | United States | 93306 |
| 3 | Pain Consultants of San Diego | Chula Vista | California | United States | 91914 |
| 4 | Pain Medicine Associates, Inc. | Fountain Valley | California | United States | 92708 |
| 5 | UCSD Medical Center - Jacobs Medical Center | La Jolla | California | United States | 92037 |
| 6 | California Orthopedics & Spine | Larkspur | California | United States | 94939 |
| 7 | Newport Beach Headache and Pain | Newport Beach | California | United States | 92660 |
| 8 | Vitamed Research | Rancho Mirage | California | United States | 92270 |
| 9 | Pacific Pain Management, Inc. | Ventura | California | United States | 93003 |
| 10 | IPM Medical Group Inc. | Walnut Creek | California | United States | 94598 |
| 11 | Barolat Neuroscience | Denver | Colorado | United States | 80218 |
| 12 | Advanced Diagnostic Pain Treatment Centers | New Haven | Connecticut | United States | 06511 |
| 13 | South Lake Pain Institute, Inc | Clermont | Florida | United States | 34711 |
| 14 | Florida Spine Specialists | Fort Lauderdale | Florida | United States | 33308 |
| 15 | Louis J. Raso, MD, PA | Jupiter | Florida | United States | 33477 |
| 16 | Florida Pain Institute | Merritt Island | Florida | United States | 32953 |
| 17 | Advanced Interventional Pain Management and Research Clinic, Inc. | Miami Gardens | Florida | United States | 33169 |
| 18 | Florida Pain Clinic | Ocala | Florida | United States | 34471 |
| 19 | Orthomicrospine | Pensacola | Florida | United States | 32503 |
| 20 | West Florida Orthopedics and Spine Surgery | Pensacola | Florida | United States | 32514 |
| 21 | Orthopedic Research Foundation | Savannah | Georgia | United States | 31405 |
| 22 | Tripler Army Medical Center | Honolulu | Hawaii | United States | 96859 |
| 23 | Axis Spine Center | Coeur d'Alene | Idaho | United States | 83815 |
| 24 | Pain and Spine Specialists of Idaho | Idaho Falls | Idaho | United States | 83404 |
| 25 | Northwestern Memorial Hospital | Chicago | Illinois | United States | 60611 |
| 26 | Summit Research Institute | Fort Wayne | Indiana | United States | 46825 |
| 27 | Precision Spine Care | Overland Park | Kansas | United States | 66211 |
| 28 | Willis-Knighton River Cities Clinical Research Center | Shreveport | Louisiana | United States | 71105 |
| 29 | Pain and Spine Specialist of Maryland | Mount Airy | Maryland | United States | 21771 |
| 30 | Multidisciplinary Pain Management Services | Okemos | Michigan | United States | 48864 |
| 31 | Forest Health Medical Center | Ypsilanti | Michigan | United States | 48198 |
| 32 | Twin Cities Pain Clinic & Surgery Center | Edina | Minnesota | United States | 55439 |
| 33 | NeuroSpecs-Gulfport Performance Spine | Gulfport | Mississippi | United States | 39503 |
| 34 | Comprehensive Pain & Rehabilitation | Pascagoula | Mississippi | United States | 39581 |
| 35 | Saint Louis Pain Consultants | Chesterfield | Missouri | United States | 63017 |
| 36 | Mercy Medical Research Institute | Springfield | Missouri | United States | 65804 |
| 37 | Albany Medical Center | Albany | New York | United States | 12208 |
| 38 | Jeffrey M. Epstein, M.D. PC | Babylon | New York | United States | 11702 |
| 39 | Montefiore Medical Center | Bronx | New York | United States | 10461 |
| 40 | Spine and Skeletal Pain Medicine | Utica | New York | United States | 13502 |
| 41 | Integrative Pain and Wellness Associates | Williamsville | New York | United States | 14221 |
| 42 | Vidant Roanoke - Chowan Hospital Pain Center | Ahoskie | North Carolina | United States | 27910 |
| 43 | Carolinas Research Institute, PLLC | Huntersville | North Carolina | United States | 28078 |
| 44 | Crystal Coast Pain Management | New Bern | North Carolina | United States | 28560 |
| 45 | Piedmont Interventional Pain Care | Salisbury | North Carolina | United States | 28147 |
| 46 | The Center for Clinical Research, LLC | Winston-Salem | North Carolina | United States | 27103 |
| 47 | University Hospitals of Cleveland | Cleveland | Ohio | United States | 44106 |
| 48 | Orthopaedic and Spine Center | Dublin | Ohio | United States | 43016 |
| 49 | Cincinnati Comprehensive Pain Center | Fairfield | Ohio | United States | 45014 |
| 50 | Western Reserve Spine and Pain Institute | Kent | Ohio | United States | 44240 |
| 51 | Toledo Clinic | Toledo | Ohio | United States | 43623 |
| 52 | University of Toledo Medical Center | Toledo | Ohio | United States | 43623 |
| 53 | Pacific Sports and Spine, LLC | Eugene | Oregon | United States | 97401 |
| 54 | Quave Clinic | Medford | Oregon | United States | 97504 |
| 55 | Summit Spine | Portland | Oregon | United States | 97225 |
| 56 | Geisinger Medical Center | Danville | Pennsylvania | United States | 17822 |
| 57 | Florence Neurosurgery and Spine | Florence | South Carolina | United States | 29506 |
| 58 | Interventional Spine and Pain Center | Manchester | Tennessee | United States | 37355 |
| 59 | Pain Center Physicians | Austin | Texas | United States | 78704 |
| 60 | Balcones Pain Consultants | Austin | Texas | United States | 78750 |
| 61 | KSF Orthopaedics | Houston | Texas | United States | 77090 |
| 62 | Central Texas Pain Institute | Killeen | Texas | United States | 76542 |
| 63 | Advanced Spine Pain Solutions | Laredo | Texas | United States | 78041 |
| 64 | Spine Team Texas | Southlake | Texas | United States | 76092 |
| 65 | Space City Pain Specialists | Webster | Texas | United States | 77598 |
| 66 | Carilion Roanoke Memorial Hospital | Roanoke | Virginia | United States | 24014 |
| 67 | EvergreenHealth Pain Care | Kirkland | Washington | United States | 98034 |
| 68 | Mind Your Body Institute | Seattle | Washington | United States | 98115 |
| 69 | Northwest Pain Care | Spokane | Washington | United States | 99201 |
| 70 | West Virginia University Hospitals | Morgantown | West Virginia | United States | 26506 |
| 71 | Interventional Pain Specialists of Wisconsin | Rice Lake | Wisconsin | United States | 54868 |
| 72 | Berwick Pain Management | Berwick | Australia | ||
| 73 | Hunter Pain Clinic | Broadmeadow | Australia | ||
| 74 | Monash Clinical Research | Caulfield South | Australia | ||
| 75 | Green Lizard Science | Claremont | Australia | ||
| 76 | Sydney Spine and Pain Pty Ltd | Hurstville | Australia | ||
| 77 | Sunshine Coast Clinical Research | Noosa Heads | Australia | ||
| 78 | Womens Health and Research Institute of Australia | Sydney | Australia | ||
| 79 | Pain Medicine of South Australia | Wayville | Australia | ||
| 80 | Clinique de la Sauvegarde | Lyon | France | ||
| 81 | Fondation Ophtalmologique Adolphe de Rothschild | Paris | France | ||
| 82 | CHU La Miletrie | Poitiers | France | ||
| 83 | CHU de Nantes-Hopital Laennec | Saint-Herblain | France | ||
| 84 | University Berlin, Charite Virchow Standort, Wedding | Berlin-Wedding | Germany | ||
| 85 | Universitaetsklinikum Dusseldorf | Duesseldorf | Germany | ||
| 86 | St. Marien-Hospital Hamm | Hamm | Germany | ||
| 87 | Pres. Osp. Civile Santi Antonio e Biagio | Alessandria | Italy | ||
| 88 | Az. Osp. Monaldi | Napoli | Italy | ||
| 89 | Ospedale San Giuliano | Rionero In Vulture | Italy | ||
| 90 | Ospedale S. Giovanni Addolorata | Rome | Italy | 30326 | |
| 91 | Ziekenhuis Rijnstate | Velp | Netherlands | ||
| 92 | Ponce Interventional Pain Center | Ponce | Puerto Rico | 716 | |
| 93 | Hospital San Pedro | Logroño | Spain | ||
| 94 | Fundacion Jimenez Diaz | Madrid | Spain | ||
| 95 | Hospital La Paz | Madrid | Spain | ||
| 96 | Hospital Universitario Quiron Madrid | Madrid | Spain | ||
| 97 | Hospital Virgen Del Rocio | Sevilla | Spain | ||
| 98 | H. Clinico Universitario | Valencia | Spain | ||
| 99 | Hospital de la Ribera | Valencia | Spain | ||
| 100 | Hospital Universitario La Fe | Valencia | Spain | ||
| 101 | Sahlgrenska University Hospital | Goeteborg | Sweden | ||
| 102 | La Tour Hospital | Meyrin | Switzerland | ||
| 103 | Ospedale Regionale di Lugano | Viganello | Switzerland | ||
| 104 | Basildon and Thurrock University Hospitals NHS | Basildon | United Kingdom | ||
| 105 | Southmead Hospital Bristol | Bristol | United Kingdom | ||
| 106 | St. Bartholomews Hospital | London | United Kingdom | ||
| 107 | James Cook University Hospital | Middlesbrough | United Kingdom |
Sponsors and Collaborators
- Boston Scientific Corporation
Investigators
- Study Director: Roshini Jain, Boston Scientific Neuromodulation Corporation
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT01550575
Other Study ID Numbers:
- A7005
First Posted:
Mar 12, 2012
Last Update Posted:
Aug 3, 2022
Last Verified:
Aug 1, 2022
Additional relevant MeSH terms: