Chronic PainMAPNCT01583894
Multiple Areas of Pain (MAP)
An observational study of Chronic Pain, run by Boston Scientific Corporation at 15 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain
- How many people
- 828 participants
- Where
- 15 sitesUnited States
- Study dates
- Jun 2012to Mar 2014
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Chronic pain patients resident in a US pain management practice.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
Johns Hopkins Hospital
Baltimore, Maryland, 21287
Millennium Pain Center
Bloomington, Illinois, 61701
Midwest Pain Center
Chesterfield, Missouri, 63005
University Hospitals of Cleveland
Cleveland, Ohio, 44106
Geisinger Medical Center
Danville, Pennsylvania, 17822
Global Scientific Innovations - Advanced Pain Care Clinic
Evansville, Indiana, 47714
Houston Pain Associates
Houston, Texas, 77030
UCSD Medical Center - Jacobs Medical Center
La Jolla, California, 92037
Neurovations
Napa, California, 94558
Comprehensive Pain & Rehabilitation
Pascagoula, Mississippi, 39581
Channel Research
Pawleys Island, South Carolina, 29585
Nexus Pain Care
Provo, Utah, 84604
Integrated Pain Specialists of Southern California
San Diego, California, 99123
Sheridan Clinical Research
Sunrise, Florida, 33323
The Center for Clinical Research, LLC
Winston-Salem, North Carolina, 27103
About this study
Official title: 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.
- Conditions
- Chronic Pain
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Chronic pain patients | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: single-visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2012 (estimated)
- Study startJun 2012
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by Boston Scientific CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 828 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Roshini Jain, Study director, Boston Scientific Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01583894
- Sponsor's protocol ID
- A7003
- Other IDs
- CDM00044807
- Acronym
- MAP
- Status last verified
- Nov 2020
- First submitted
- 23 Apr 2012
- Last updated
- 25 Nov 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multiple Areas of Pain (MAP): Epidemiology of Multisite Pain in the Chronic Pain Population
- ClinicalTrials.gov ID
- NCT01583894
- Acronym / sponsor ID
- MAP / A7003
- Conditions
- Chronic Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 828 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- Jun 2012
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 24 Apr 2012 (estimated)
- Results
- Posted 30 Dec 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chronic pain patients | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Chronic pain patients resident in a US pain management practice.
Key inclusion criteria (5 listed)
- 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 (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roshini Jain study director
Boston Scientific Corporation
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Pain, run by Boston Scientific Corporation at 15 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Dec 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Multi-site Pain Index (time frame: single-visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2020.