Measuring the Context of Healing in Chronic Pain Treatment (HEALpain)
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|ClinicalTrials.gov Identifier: NCT02873429|
Recruitment Status : Completed
First Posted : August 19, 2016
Results First Posted : August 2, 2017
Last Update Posted : August 2, 2017
|Condition or disease|
|Study Type :||Observational|
|Actual Enrollment :||218 participants|
|Observational Model:||Ecologic or Community|
|Official Title:||Measuring the Context of Healing: Using PROMIS in Chronic Pain Treatment|
|Study Start Date :||February 2015|
|Actual Primary Completion Date :||December 2016|
|Actual Study Completion Date :||January 2017|
Integrative Medicine (Complementary /Alternative)Group
Patients receiving chiropractic care, acupuncture, massage therapy, or meditation training for chronic pain
Conventional Medicine Group
Patients receiving conventional medicine care (physical therapy, medication management, injections, etc.) for chronic pain.
- PROMIS Pain Intensity [ Time Frame: 6-8 weeks ]PROMIS Pain Intensity is a three item scale measuring the severity of pain at its worst (past week), average (past week), and current level using a five-point Likert-type scale (i.e., no pain=1, mild=2, moderate=3, severe=4, very severe=5). Scores on the 3 items are summed to create a raw score, which can range from 3 to 15. The raw score is converted to a T-score metric in which 50 is the mean of the relevant reference population and 10 is the standard deviation (SD) of that population.(see http://www.healthmeasures.net/promis-scoring-manuals for details ).
- PROMIS Pain Interference [ Time Frame: 6-8 weeks ]Computerized adaptive test measuring interference of pain in everyday functioning using five-point Likert-type scales with two types or response options (i.e., "not at all"=1, "a little bit"=2, "somewhat"=3, "quite a bit"=4, "very much"=5, and "never"=1, "rarely"=2, "sometimes"=3, "often"=4, "always"=5). Scores on the items are summed to create a raw score. The raw score is converted to a T-score metric in which 50 is the mean of the relevant reference population and 10 is the standard deviation (SD) of that population.(see http://www.healthmeasures.net for details of CAT administration and scoring).
- Clinical Global Impression of Change (CGI) [ Time Frame: 6-8 weeks ]Patient's rating of current symptom level compared to baseline assessment using a five-point bipolar scale: Much better(2), Somewhat better(1), No change(0), Somewhat worse(-1), Much worse(-2)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02873429
|United States, Pennsylvania|
|University of Pittsburgh Medical Center|
|Pittsburgh, Pennsylvania, United States, 15213|
|Principal Investigator:||Carol M Greco, PhD||University of Pittsburgh|