Chronic Pain
Conditions
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.
Interventions
None listed
Sponsors
Boston Scientific Corporation
Study design
Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Multi-site Pain Index | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Chronic Pain Patients Patients suffering from chronic intractable pain of the trunk and/or limbs for a duration of at least 6 months | 828 |
| Total | 828 |
Baseline characteristics
| Characteristic | Chronic Pain Patients |
|---|---|
| Age, Continuous | 52.3 years STANDARD_DEVIATION 13.23 |
| Sex/Gender, Customized Female | 527 participants |
| Sex/Gender, Customized Male | 299 participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Chronic Pain Patients | Multi-site Pain Index | 0.52 units on a scale | Standard Deviation 0.13 |