Multiple Areas of Pain (MAP)

Completed

• Conditions: Chronic Pain

• Registration Number: NCT01583894
• Lead Sponsor: 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2012-04-23
• Study First Submitted QC: 2012-04-23
• Study First Posted: 2012-04-24
• Study Start: 2012-06
• Primary Completion: 2014-03
• Study Completion: 2014-03
• Results First Submitted: 2014-12-18
• Results First Submitted QC: 2014-12-18
• Results First Posted: 2014-12-30
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-11
• Last Update Posted: 2020-11-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 828

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Multi-site Pain Index	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.

Trial Locations

Locations (15)

Millennium Pain Center; 🇺🇸 Bloomington, Illinois, United States

Neurovations; 🇺🇸 Napa, California, United States

UCSD Medical Center - Jacobs Medical Center; 🇺🇸 La Jolla, California, United States

Sheridan Clinical Research; 🇺🇸 Sunrise, Florida, United States

Global Scientific Innovations - Advanced Pain Care Clinic; 🇺🇸 Evansville, Indiana, United States

Nexus Pain Care; 🇺🇸 Provo, Utah, United States

Comprehensive Pain & Rehabilitation; 🇺🇸 Pascagoula, Mississippi, United States

Johns Hopkins Hospital; 🇺🇸 Baltimore, Maryland, United States

Midwest Pain Center; 🇺🇸 Chesterfield, Missouri, United States

University Hospitals of Cleveland; 🇺🇸 Cleveland, Ohio, United States

Geisinger Medical Center; 🇺🇸 Danville, Pennsylvania, United States

Integrated Pain Specialists of Southern California; 🇺🇸 San Diego, California, United States

Houston Pain Associates; 🇺🇸 Houston, Texas, United States

Channel Research; 🇺🇸 Pawleys Island, South Carolina, United States

The Center for Clinical Research, LLC; 🇺🇸 Winston-Salem, North Carolina, United States