Clinical trial NCT01583894: Multiple Areas of Pain (MAP)
Official title: Multiple Areas of Pain (MAP): Epidemiology of Multisite Pain in the Chronic Pain Population
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Pain
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2012-04-24
Enrollment: 828
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Chronic pain patients resident in a US pain management practice.

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.


Eligibility 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

Primary outcomes:
measure: Multi-site Pain Index
timeFrame: single-visit
Secondary outcomes:
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: UCSD Medical Center - Jacobs Medical Center
state: California
city: Napa
country: United States
facility: Neurovations
state: California
city: San Diego
country: United States
facility: Integrated Pain Specialists of Southern California
state: California
city: Sunrise
country: United States
facility: Sheridan Clinical Research
state: Florida
city: Bloomington
country: United States
facility: Millennium Pain Center
state: Illinois
city: Evansville
country: United States
facility: Global Scientific Innovations - Advanced Pain Care Clinic
state: Indiana
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
city: Pascagoula
country: United States
facility: Comprehensive Pain & Rehabilitation
state: Mississippi
city: Chesterfield
country: United States
facility: Midwest Pain Center
state: Missouri
city: Winston-Salem
country: United States
facility: The Center for Clinical Research, LLC
state: North Carolina
city: Cleveland
country: United States
facility: University Hospitals of Cleveland
state: Ohio
city: Danville
country: United States
facility: Geisinger Medical Center
state: Pennsylvania
city: Pawleys Island
country: United States
facility: Channel Research
state: South Carolina
city: Houston
country: United States
facility: Houston Pain Associates
state: Texas
city: Provo
country: United States
facility: Nexus Pain Care
state: Utah
Study officials:
affiliation: Boston Scientific Corporation
name: Roshini Jain
role: STUDY_DIRECTOR
References: