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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01550575




Registration number
NCT01550575
Ethics application status
Date submitted
5/03/2012
Date registered
12/03/2012
Date last updated
12/06/2024

Titles & IDs
Public title
Patient Retrospective Outcomes (PRO)
Scientific title
Patient Retrospective Outcomes (PRO)
Secondary ID [1] 0 0
A7005
Universal Trial Number (UTN)
Trial acronym
PRO
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Pain 0 0
Condition category
Condition code
Neurological 0 0 0 0
Other neurological disorders
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Devices - Non Boston Scientific Systems
Treatment: Devices - Boston Scientific Systems

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.

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.


Treatment: Devices: Non Boston Scientific Systems
Spinal cord stimulation, RF, IDS etc.

Treatment: Devices: Boston Scientific Systems
Spinal cord stimulation, RF, IDS etc
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Responder rate
Timepoint [1] 0 0
Through study completion, approximately two years

Eligibility
Key inclusion criteria
Key

* Previously treated with or eligible for use with Boston Scientific Systems
* 18 years of age or older at the start of Baseline
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose
Duration
Selection
Timing
Retrospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
3/04/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2027
Actual
Sample size
Target
10000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Berwick Pain Management - Berwick
Recruitment hospital [2] 0 0
Hunter Pain Clinic - Broadmeadow
Recruitment hospital [3] 0 0
Monash Clinical Research - Caulfield South
Recruitment hospital [4] 0 0
Green Lizard Science - Claremont
Recruitment hospital [5] 0 0
Sydney Spine and Pain Pty Ltd - Hurstville
Recruitment hospital [6] 0 0
Sunshine Coast Clinical Research - Noosa Heads
Recruitment hospital [7] 0 0
Womens Health and Research Institute of Australia - Sydney
Recruitment hospital [8] 0 0
Pain Medicine of South Australia - Wayville
Recruitment postcode(s) [1] 0 0
- Berwick
Recruitment postcode(s) [2] 0 0
- Broadmeadow
Recruitment postcode(s) [3] 0 0
- Caulfield South
Recruitment postcode(s) [4] 0 0
- Claremont
Recruitment postcode(s) [5] 0 0
- Hurstville
Recruitment postcode(s) [6] 0 0
- Noosa Heads
Recruitment postcode(s) [7] 0 0
- Sydney
Recruitment postcode(s) [8] 0 0
- Wayville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Connecticut
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Georgia
Country [7] 0 0
United States of America
State/province [7] 0 0
Hawaii
Country [8] 0 0
United States of America
State/province [8] 0 0
Idaho
Country [9] 0 0
United States of America
State/province [9] 0 0
Illinois
Country [10] 0 0
United States of America
State/province [10] 0 0
Indiana
Country [11] 0 0
United States of America
State/province [11] 0 0
Kansas
Country [12] 0 0
United States of America
State/province [12] 0 0
Louisiana
Country [13] 0 0
United States of America
State/province [13] 0 0
Maryland
Country [14] 0 0
United States of America
State/province [14] 0 0
Michigan
Country [15] 0 0
United States of America
State/province [15] 0 0
Minnesota
Country [16] 0 0
United States of America
State/province [16] 0 0
Mississippi
Country [17] 0 0
United States of America
State/province [17] 0 0
Missouri
Country [18] 0 0
United States of America
State/province [18] 0 0
New York
Country [19] 0 0
United States of America
State/province [19] 0 0
North Carolina
Country [20] 0 0
United States of America
State/province [20] 0 0
Ohio
Country [21] 0 0
United States of America
State/province [21] 0 0
Oregon
Country [22] 0 0
United States of America
State/province [22] 0 0
Pennsylvania
Country [23] 0 0
United States of America
State/province [23] 0 0
South Carolina
Country [24] 0 0
United States of America
State/province [24] 0 0
Tennessee
Country [25] 0 0
United States of America
State/province [25] 0 0
Texas
Country [26] 0 0
United States of America
State/province [26] 0 0
Virginia
Country [27] 0 0
United States of America
State/province [27] 0 0
Washington
Country [28] 0 0
United States of America
State/province [28] 0 0
West Virginia
Country [29] 0 0
United States of America
State/province [29] 0 0
Wisconsin
Country [30] 0 0
France
State/province [30] 0 0
Lyon
Country [31] 0 0
France
State/province [31] 0 0
Paris
Country [32] 0 0
France
State/province [32] 0 0
Poitiers
Country [33] 0 0
France
State/province [33] 0 0
Saint-Herblain
Country [34] 0 0
France
State/province [34] 0 0
Suresnes
Country [35] 0 0
Germany
State/province [35] 0 0
Berlin-Wedding
Country [36] 0 0
Germany
State/province [36] 0 0
Cologne
Country [37] 0 0
Germany
State/province [37] 0 0
Duesseldorf
Country [38] 0 0
Germany
State/province [38] 0 0
Hamm
Country [39] 0 0
Italy
State/province [39] 0 0
Alessandria
Country [40] 0 0
Italy
State/province [40] 0 0
Napoli
Country [41] 0 0
Italy
State/province [41] 0 0
Rionero In Vulture
Country [42] 0 0
Italy
State/province [42] 0 0
Rome
Country [43] 0 0
Netherlands
State/province [43] 0 0
Leiderdorp
Country [44] 0 0
Netherlands
State/province [44] 0 0
Velp
Country [45] 0 0
Puerto Rico
State/province [45] 0 0
Ponce
Country [46] 0 0
Spain
State/province [46] 0 0
Barcelona
Country [47] 0 0
Spain
State/province [47] 0 0
Logroño
Country [48] 0 0
Spain
State/province [48] 0 0
Madrid
Country [49] 0 0
Spain
State/province [49] 0 0
Sevilla
Country [50] 0 0
Spain
State/province [50] 0 0
Valencia
Country [51] 0 0
Sweden
State/province [51] 0 0
Goeteborg
Country [52] 0 0
Switzerland
State/province [52] 0 0
Meyrin
Country [53] 0 0
Switzerland
State/province [53] 0 0
Viganello
Country [54] 0 0
United Kingdom
State/province [54] 0 0
Basildon
Country [55] 0 0
United Kingdom
State/province [55] 0 0
Bristol
Country [56] 0 0
United Kingdom
State/province [56] 0 0
Leeds
Country [57] 0 0
United Kingdom
State/province [57] 0 0
London
Country [58] 0 0
United Kingdom
State/province [58] 0 0
Middlesbrough

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Boston Scientific Corporation
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT01550575
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Natalie Bloom Lyons
Address 0 0
Boston Scientific Neuromodulation Corporation
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Alison Lewis
Address 0 0
Country 0 0
Phone 0 0
855-213-9890
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01550575