Trial Outcomes & Findings for Multiple Areas of Pain (MAP) (NCT NCT01583894)

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

828 participants

Primary outcome timeframe

single-visit

Results posted on

2020-11-25

Participant Flow

Participant milestones

Participant milestones
Measure	Chronic Pain Patients Patients suffering from chronic intractable pain of the trunk and/or limbs for a duration of at least 6 months
Overall Study STARTED	828
Overall Study COMPLETED	813
Overall Study NOT COMPLETED	15

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Multiple Areas of Pain (MAP)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Chronic Pain Patients n=828 Participants Patients suffering from chronic intractable pain of the trunk and/or limbs for a duration of at least 6 months
Age, Continuous	52.3 years STANDARD_DEVIATION 13.23 • n=93 Participants
Sex/Gender, Customized Female	527 participants n=93 Participants
Sex/Gender, Customized Male	299 participants n=93 Participants

PRIMARY outcome

Timeframe: single-visit

Population: MSPI was calculated using multiple pain descriptors which were obtained from pain drawings. 810 of the 813 patients that completed the study provided complete pain drawing data, and so MSPI could be calculated only in 810 patients.

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.

Outcome measures

Outcome measures
Measure	Chronic Pain Patients n=810 Participants Patients suffering from chronic intractable pain of the trunk and/or limbs for a duration of at least 6 months
Multi-site Pain Index	0.52 units on a scale Standard Deviation 0.13

Adverse Events

Chronic Pain Patients

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Nitzan Mekel-Bobrov, Director of Scientific Communications

Boston Scientific Corporation

Phone: 6619494537

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place