Multiple Areas of Pain (MAP)
This study is currently recruiting participants.
Verified May 2013 by Boston Scientific Corporation
Sponsor:
Boston Scientific Corporation
Information provided by (Responsible Party):
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT01583894
First received: April 23, 2012
Last updated: May 3, 2013
Last verified: May 2013
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Purpose
This study will collect pain-related information from chronic pain patients to gain understanding of how common multi-site pain is and how it affects health outcomes like function, quality of life, depression, and anxiety.
| Condition |
|---|
|
Chronic Pain |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Cross-Sectional |
| Official Title: | Multiple Areas of Pain (MAP): Epidemiology of Multisite Pain in the Chronic Pain Population |
Resource links provided by NLM:
Further study details as provided by Boston Scientific Corporation:
Primary Outcome Measures:
- Epidemiological characterization of multisite pain in SCS-eligible patients with chronic pain of the trunk and/or limbs. [ Time Frame: After single visit ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 1000 |
| Study Start Date: | July 2012 |
| Estimated Study Completion Date: | July 2013 |
| Estimated Primary Completion Date: | July 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
| Chronic pain patients |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Chronic pain patients resident in a US pain management practice.
Criteria
Key Inclusion Criteria:
- Chronic pain of the trunk and/or limbs lasting at least 6 months
- Overall pain intensity of at least 5 on a 0 to 10 scale
- Subject is able to independently complete all assessments in English
- 18 years of age or older
- Subject signs an IRB-approved informed consent form provided in English
Key Exclusion Criteria:
- Currently implanted with an active implantable medical device to treat pain
- Currently exhibits any characteristic that renders the subject ineligible for current or future treatment with spinal cord stimulation for chronic pain of the trunk and/or limbs
- Subject has undergone an interventional pain procedure less than 1 month prior to the study
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01583894
Contacts
| Contact: Ann Masuda, M.S. | 661-949-4726 | Ann.Masuda@bsci.com |
| Contact: Valerie Lucero-Cimmarusti, B.S. | 661-949-4745 | Valerie.Cimmarusti@bsci.com |
Locations
| United States, California | |
| Boston Scientific Clinical Research Information Toll Free Number | Recruiting |
| Valencia, California, United States, 91355 | |
| Contact 855-213-9890 BSNClinicalTrials@bsci.com | |
| Principal Investigator: Allen W. Burton, M.D. | |
| Principal Investigator: Steven P. Cohen, M.D. | |
| Principal Investigator: Edward J. Frankoski, D.O. | |
| Principal Investigator: Eric J. Grigsby, M.D. | |
| Principal Investigator: Leonardo Kapural, M.D., Ph.D. | |
| Principal Investigator: Patrick J. McIntyre, M.D., J.D. | |
| Principal Investigator: Richard M. Rosenthal, M.D. | |
| Principal Investigator: Mahendra R. Sanapati, M.D. | |
| Principal Investigator: Kevin S. Smith, M.D. | |
| Principal Investigator: Stephen G. Smith, M.D. | |
| Principal Investigator: Ricardo Vallejo, M.D., Ph.D. | |
| Principal Investigator: Channing Willoughby, M.D. | |
| Principal Investigator: Thomas L. Yearwood, M.D., Ph.D. | |
Sponsors and Collaborators
Boston Scientific Corporation
Investigators
| Study Director: | Tamara Baynham, Ph.D. | Boston Scientific Corporation |
More Information
No publications provided
| Responsible Party: | Boston Scientific Corporation |
| ClinicalTrials.gov Identifier: | NCT01583894 History of Changes |
| Other Study ID Numbers: | A7003, CDM00044807 |
| Study First Received: | April 23, 2012 |
| Last Updated: | May 3, 2013 |
| Health Authority: | United States: Institutional Review Board |
ClinicalTrials.gov processed this record on May 22, 2013