Multiple Areas of Pain (MAP) (MAP)

Multiple Areas of Pain (MAP): Epidemiology of Multisite Pain in the Chronic Pain Population

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.

Study Overview

• Status: Completed
• Conditions: Chronic Pain

• Study Type: Observational
• Enrollment (Actual): 828

Contacts and Locations

Study Locations

• United States
  • California
    • La Jolla, California, United States, 92037
      • UCSD Medical Center - Jacobs Medical Center
    • Napa, California, United States, 94558
      • Neurovations
    • San Diego, California, United States, 99123
      • Integrated Pain Specialists of Southern California
  • Florida
    • Sunrise, Florida, United States, 33323
      • Sheridan Clinical Research
  • Illinois
    • Bloomington, Illinois, United States, 61701
      • Millennium Pain Center
  • Indiana
    • Evansville, Indiana, United States, 47714
      • Global Scientific Innovations - Advanced Pain Care Clinic
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Johns Hopkins Hospital
  • Mississippi
    • Pascagoula, Mississippi, United States, 39581
      • Comprehensive Pain & Rehabilitation
  • Missouri
    • Chesterfield, Missouri, United States, 63005
      • Midwest Pain Center
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27103
      • The Center for Clinical Research, LLC
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • University Hospitals of Cleveland
  • Pennsylvania
    • Danville, Pennsylvania, United States, 17822
      • Geisinger Medical Center
  • South Carolina
    • Pawleys Island, South Carolina, United States, 29585
      • Channel Research
  • Texas
    • Houston, Texas, United States, 77030
      • Houston Pain Associates
  • Utah
    • Provo, Utah, United States, 84604
      • Nexus Pain Care

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Chronic pain patients resident in a US pain management practice.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Chronic pain patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Multi-site Pain Index	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.	single-visit

Collaborators and Investigators

• Sponsor: Boston Scientific Corporation

Study record dates

Study Major Dates

• Study Start: June 1, 2012
• Primary Completion (Actual): March 1, 2014
• Study Completion (Actual): March 1, 2014

Study Registration Dates

• First Submitted: April 23, 2012
• First Submitted That Met QC Criteria: April 23, 2012
• First Posted (Estimate): April 24, 2012

Study Record Updates

• Last Update Posted (Actual): November 25, 2020
• Last Update Submitted That Met QC Criteria: November 11, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain
• Other Study ID Numbers: A7003; CDM00044807 (Other Identifier: BSC protocol number)