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Clinical Trials/NCT01583894
NCT01583894
Completed
Not Applicable

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

Boston Scientific Corporation15 sites in 1 country828 target enrollmentJune 2012
ConditionsChronic Pain

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic Pain
Sponsor
Boston Scientific Corporation
Enrollment
828
Locations
15
Primary Endpoint
Multi-site Pain Index
Status
Completed
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 2012
End Date
March 2014
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

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

Outcomes

Primary Outcomes

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.

Study Sites (15)

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