Trial Outcomes & Findings for Measuring the Context of Healing in Chronic Pain Treatment (NCT NCT02873429)
NCT ID: NCT02873429
Last Updated: 2017-08-02
Results Overview
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 ).
COMPLETED
218 participants
6-8 weeks
2017-08-02
Participant Flow
Over a 1 year period, 218 persons beginning treatment for chronic pain at conventional medicine clinics (pain clinics, physical therapy, primary care) (n=105), and integrative medicine centers (n=113) were invited to complete online assessments at 3 time-points: Baseline, 2 month, and 4 month follow-up.
9 participants enrolled (completed consent) and did not continue in the study: 2 Integrative / Complementary Alternative Medicine (CAM) and 1 Conventional withdrew after signing consent form; 2 CAM and 4 Conventional did not meet eligibility criteria after signing consent form.
Participant milestones
| Measure |
Integrative Medicine 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.
|
|---|---|---|
|
Baseline
STARTED
|
109
|
100
|
|
Baseline
COMPLETED
|
109
|
100
|
|
Baseline
NOT COMPLETED
|
0
|
0
|
|
6-8 Weeks
STARTED
|
105
|
98
|
|
6-8 Weeks
COMPLETED
|
95
|
97
|
|
6-8 Weeks
NOT COMPLETED
|
10
|
1
|
|
16 Weeks
STARTED
|
105
|
98
|
|
16 Weeks
COMPLETED
|
100
|
96
|
|
16 Weeks
NOT COMPLETED
|
5
|
2
|
Reasons for withdrawal
| Measure |
Integrative Medicine 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.
|
|---|---|---|
|
6-8 Weeks
Missed 6-8 week, eligible for 16 week
|
10
|
1
|
|
16 Weeks
Completed 6-8 week, missed 16 week
|
2
|
2
|
|
16 Weeks
Lost to Follow-up
|
3
|
0
|
Baseline Characteristics
Measuring the Context of Healing in Chronic Pain Treatment
Baseline characteristics by cohort
| Measure |
Integrative Medicine Group
n=109 Participants
Patients receiving chiropractic care, acupuncture, massage therapy, or meditation training for chronic pain
|
Conventional Medicine Group
n=100 Participants
Patients receiving conventional medicine care (physical therapy, medication management, injections, etc.) for chronic pain.
|
Total
n=209 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
45.6 years
STANDARD_DEVIATION 14.5 • n=5 Participants
|
49.5 years
STANDARD_DEVIATION 15.0 • n=7 Participants
|
47.5 years
STANDARD_DEVIATION 14.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
82 Participants
n=5 Participants
|
75 Participants
n=7 Participants
|
157 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
11 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
97 Participants
n=5 Participants
|
97 Participants
n=7 Participants
|
194 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
12 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
87 Participants
n=5 Participants
|
72 Participants
n=7 Participants
|
159 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Education
Less than 4-year degree
|
53 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
100 Participants
n=5 Participants
|
|
Education
Greater than or equal to 4-year degree
|
55 Participants
n=5 Participants
|
53 Participants
n=7 Participants
|
108 Participants
n=5 Participants
|
|
Education
Missing
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6-8 weeksPROMIS 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 ).
Outcome measures
| Measure |
Integrative Medicine Group
n=105 Participants
Patients receiving chiropractic care, acupuncture, massage therapy, or meditation training for chronic pain
|
Conventional Medicine Group
n=98 Participants
Patients receiving conventional medicine care (physical therapy, medication management, injections, etc.) for chronic pain.
|
|---|---|---|
|
PROMIS Pain Intensity
|
50.1 T-score metric
Standard Deviation 6.6
|
52.9 T-score metric
Standard Deviation 6.2
|
PRIMARY outcome
Timeframe: 6-8 weeksComputerized 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).
Outcome measures
| Measure |
Integrative Medicine Group
n=109 Participants
Patients receiving chiropractic care, acupuncture, massage therapy, or meditation training for chronic pain
|
Conventional Medicine Group
n=100 Participants
Patients receiving conventional medicine care (physical therapy, medication management, injections, etc.) for chronic pain.
|
|---|---|---|
|
PROMIS Pain Interference
|
59.4 T-score metric
Standard Deviation 8.1
|
63.1 T-score metric
Standard Deviation 6.6
|
SECONDARY outcome
Timeframe: 6-8 weeksPatient'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)
Outcome measures
| Measure |
Integrative Medicine Group
n=109 Participants
Patients receiving chiropractic care, acupuncture, massage therapy, or meditation training for chronic pain
|
Conventional Medicine Group
n=100 Participants
Patients receiving conventional medicine care (physical therapy, medication management, injections, etc.) for chronic pain.
|
|---|---|---|
|
Clinical Global Impression of Change (CGI)
Much better
|
16 participants
|
9 participants
|
|
Clinical Global Impression of Change (CGI)
Better
|
46 participants
|
51 participants
|
|
Clinical Global Impression of Change (CGI)
No change
|
20 participants
|
23 participants
|
|
Clinical Global Impression of Change (CGI)
Somewhat worse
|
4 participants
|
10 participants
|
|
Clinical Global Impression of Change (CGI)
Much worse
|
1 participants
|
2 participants
|
|
Clinical Global Impression of Change (CGI)
Missing
|
22 participants
|
5 participants
|
Adverse Events
Integrative Medicine Group
Conventional Medicine Group
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Carol M. Greco, Associate Professor of Psychiatry
University of Pittsburgh
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place