NCT01583894

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
828

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2012

Geographic Reach
1 country

15 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 23, 2012

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 24, 2012

Completed
1 month until next milestone

Study Start

First participant enrolled

June 1, 2012

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
10 months until next milestone

Results Posted

Study results publicly available

December 30, 2014

Completed
Last Updated

November 25, 2020

Status Verified

November 1, 2020

Enrollment Period

1.7 years

First QC Date

April 23, 2012

Results QC Date

December 18, 2014

Last Update Submit

November 11, 2020

Conditions

Chronic Pain

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Chronic pain patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Chronic pain patients resident in a US pain management practice.

You may qualify if:

  • 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
  • years of age or older
  • Subject signs an Institutional Review Board-approved informed consent form provided in English

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

UCSD Medical Center - Jacobs Medical Center

La Jolla, California, 92037, United States

Location

Neurovations

Napa, California, 94558, United States

Location

Integrated Pain Specialists of Southern California

San Diego, California, 99123, United States

Location

Sheridan Clinical Research

Sunrise, Florida, 33323, United States

Location

Millennium Pain Center

Bloomington, Illinois, 61701, United States

Location

Global Scientific Innovations - Advanced Pain Care Clinic

Evansville, Indiana, 47714, United States

Location

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

Comprehensive Pain & Rehabilitation

Pascagoula, Mississippi, 39581, United States

Location

Midwest Pain Center

Chesterfield, Missouri, 63005, United States

Location

The Center for Clinical Research, LLC

Winston-Salem, North Carolina, 27103, United States

Location

University Hospitals of Cleveland

Cleveland, Ohio, 44106, United States

Location

Geisinger Medical Center

Danville, Pennsylvania, 17822, United States

Location

Channel Research

Pawleys Island, South Carolina, 29585, United States

Location

Houston Pain Associates

Houston, Texas, 77030, United States

Location

Nexus Pain Care

Provo, Utah, 84604, United States

Location

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Nitzan Mekel-Bobrov, Director of Scientific Communications
Organization
Boston Scientific Corporation
nitzan.mekel-bobrov@bsci.com
6619494537

Study Officials

  • Roshini Jain

    Boston Scientific Corporation

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 23, 2012

First Posted

April 24, 2012

Study Start

June 1, 2012

Primary Completion

March 1, 2014

Study Completion

March 1, 2014

Last Updated

November 25, 2020

Results First Posted

December 30, 2014

Record last verified: 2020-11

Locations

US(15)