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Multiple Areas of Pain (MAP) (MAP)

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ClinicalTrials.gov Identifier: NCT01583894
Recruitment Status : Completed
First Posted : April 24, 2012
Results First Posted : December 30, 2014
Last Update Posted : March 11, 2015
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation

Brief Summary:
This study will collect pain-related information from chronic pain patients to gain an understanding of the prevalence of multi-site pain, and how it affects health outcomes like function, quality of life, depression, and anxiety.

Condition or disease
Chronic Pain

Study Type : Observational
Actual Enrollment : 828 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Multiple Areas of Pain (MAP): Epidemiology of Multisite Pain in the Chronic Pain Population
Study Start Date : June 2012
Actual Primary Completion Date : March 2014
Actual Study Completion Date : March 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain
U.S. FDA Resources

Group/Cohort
Chronic pain patients



Primary Outcome Measures :
  1. Multi-site Pain Index [ Time Frame: single-visit ]

    Multiple Site Pain Index (MSPI) was developed by collating multiple pain descriptors into a single index. Pain descriptors used for developing this index were percent body area in pain, number of painful areas, span of painful areas, and Regional Pain Ratings (RPRs) which includes data on pain severity and pain continuity for 47 body regions.

    MSPI score ranged from 0 to 1; 0 representing no pain and 1 representing extreme continuous pain over entire body, except the head and face regions.




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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 Boston Scientific Corporation

Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT01583894     History of Changes
Other Study ID Numbers: A7003
CDM00044807 ( Other Identifier: BSC protocol number )
First Posted: April 24, 2012    Key Record Dates
Results First Posted: December 30, 2014
Last Update Posted: March 11, 2015
Last Verified: November 2013

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