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Multiple Areas of Pain (MAP)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT01583894
First received: April 23, 2012
Last updated: November 12, 2013
Last verified: November 2013
  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 ]

Enrollment: 830
Study Start Date: July 2012
Study Completion Date: September 2013
Primary Completion Date: September 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 Institutional Review Board-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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01583894

Locations
United States, California
Boston Scientific Clinical Research Information Toll Free Number
Valencia, California, United States, 91355
Sponsors and Collaborators
Boston Scientific Corporation
Investigators
Study Director: Roshini Jain, 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: November 12, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Chronic Pain
Nervous System Diseases
Neurologic Manifestations
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on November 19, 2014