Multiple Areas of Pain (MAP)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT01583894
First received: April 23, 2012
Last updated: November 12, 2013
Last verified: November 2013
  Purpose

This study will collect pain-related information from chronic pain patients to gain understanding of how common multi-site pain is and how it affects health outcomes like function, quality of life, depression, and anxiety.


Condition
Chronic Pain

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Multiple Areas of Pain (MAP): Epidemiology of Multisite Pain in the Chronic Pain Population

Resource links provided by NLM:


Further study details as provided by Boston Scientific Corporation:

Primary Outcome Measures:
  • Epidemiological characterization of multisite pain in SCS-eligible patients with chronic pain of the trunk and/or limbs. [ Time Frame: After single visit ] [ Designated as safety issue: No ]

Enrollment: 830
Study Start Date: July 2012
Study Completion Date: September 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Chronic pain patients

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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, Ph.D. Boston Scientific Corporation
  More Information

No publications provided

Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT01583894     History of Changes
Other Study ID Numbers: A7003, CDM00044807
Study First Received: April 23, 2012
Last Updated: November 12, 2013
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on April 22, 2014