Trial Outcomes & Findings for Traditional Chinese Medicine (TCM) for Temporomandibular Dysfunction (TMD): A Whole Systems Multi-site Trial (NCT NCT00856167)
NCT ID: NCT00856167
Last Updated: 2025-10-23
Results Overview
The Characteristic Facial Pain (CFP) score is a mean of participant-reported worst pain over the previous two weeks, average pain when having pain over the previous two weeks, and current pain, reported on a 0-10 VAS scale where 0 means no pain and 10 means worst possible pain.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
135 participants
Primary outcome timeframe
Beginning of each treatment period, end of each treatment period (8 weeks later)
Results posted on
2025-10-23
Participant Flow
The study took place in Tucson, Arizona, and Portland, Oregon, recruited through newspaper advertisements, and various email list-serves. In Tucson, there was also an active community outreach component to enhance the recruitment of minorities. All individuals responded to our call center in Tucson using a toll-free number. Recruitment began October 1, 2006 and ended September 1, 2007.
In the 1st period, 79 subjects were allocated to TCM (39) or SC (40). 36 TCM subjects completed the 1st period; all were removed from the allocation group for the 2nd period per study plan. 35 SC subjects completed the 1st period. 29 were allocated to TCM (15) or SC (14) for the 2nd period; 6 were removed from the allocation group due to subject choice or insufficient pain. 56 additional subjects were allocated to TCM (27) or SC (29) for the 2nd period. 135 subjects total were allocated.
Participant milestones
| Measure |
Traditional Chinese Medicine - Period 1
Whole systems traditional Chinese medicine, including individually tailored herbal formulas, acupuncture, tuna (Chinese massage), lifestyle recommendations
TCM: whole system Traditional Chinese Medicine, including acupuncture, herbs, tuina, lifestyle counseling
|
Self-care - Period 1
Self-care for TMD developed by Dworkin, LeResche et al.
Self-care for TMD: a 5-session 8 hour intervention targeting TMD knowledge, stretching and exercises, stress reduction, lifestyle modification
|
Traditional Chinese Medicine - Period 2
Whole systems traditional Chinese medicine, including individually tailored herbal formulas, acupuncture, tuna (Chinese massage), lifestyle recommendations
TCM: whole system Traditional Chinese Medicine, including acupuncture, herbs, tuina, lifestyle counseling
|
Self Care - Period 2
Self-care for TMD developed by Dworkin, LeResche et al.
Self-care for TMD: a 5-session 8 hour intervention targeting TMD knowledge, stretching and exercises, stress reduction, lifestyle modification
|
|---|---|---|---|---|
|
Period 1
STARTED
|
39
|
40
|
0
|
0
|
|
Period 1
COMPLETED
|
36
|
35
|
0
|
0
|
|
Period 1
NOT COMPLETED
|
3
|
5
|
0
|
0
|
|
Period 2
STARTED
|
0
|
0
|
42
|
43
|
|
Period 2
COMPLETED
|
0
|
0
|
37
|
38
|
|
Period 2
NOT COMPLETED
|
0
|
0
|
5
|
5
|
Reasons for withdrawal
| Measure |
Traditional Chinese Medicine - Period 1
Whole systems traditional Chinese medicine, including individually tailored herbal formulas, acupuncture, tuna (Chinese massage), lifestyle recommendations
TCM: whole system Traditional Chinese Medicine, including acupuncture, herbs, tuina, lifestyle counseling
|
Self-care - Period 1
Self-care for TMD developed by Dworkin, LeResche et al.
Self-care for TMD: a 5-session 8 hour intervention targeting TMD knowledge, stretching and exercises, stress reduction, lifestyle modification
|
Traditional Chinese Medicine - Period 2
Whole systems traditional Chinese medicine, including individually tailored herbal formulas, acupuncture, tuna (Chinese massage), lifestyle recommendations
TCM: whole system Traditional Chinese Medicine, including acupuncture, herbs, tuina, lifestyle counseling
|
Self Care - Period 2
Self-care for TMD developed by Dworkin, LeResche et al.
Self-care for TMD: a 5-session 8 hour intervention targeting TMD knowledge, stretching and exercises, stress reduction, lifestyle modification
|
|---|---|---|---|---|
|
Period 1
Withdrawal by Subject
|
1
|
4
|
0
|
0
|
|
Period 1
Lost to Follow-up
|
2
|
1
|
0
|
0
|
|
Period 2
Lost to Follow-up
|
0
|
0
|
3
|
1
|
|
Period 2
Withdrawal by Subject
|
0
|
0
|
2
|
4
|
Baseline Characteristics
In the 1st period, 79 subjects were allocated to TCM (39) or SC (40). 36 TCM subjects completed the 1st period; all were removed from the allocation group for the 2nd period per study plan. 35 SC subjects completed the 1st period. 29 were allocated to TCM (15) or SC (14) for the 2nd period; 6 were removed from the allocation group due to subject choice or insufficient pain. 56 additional subjects were allocated to TCM (27) or SC (29) for the 2nd period. 135 subjects total were allocated.
Baseline characteristics by cohort
| Measure |
Traditional Chinese Medicine - Period 1
n=39 Participants
Whole systems traditional Chinese medicine, including individually tailored herbal formulas, acupuncture, tuna (Chinese massage), lifestyle recommendations TCM: whole system Traditional Chinese Medicine, including acupuncture, herbs, tuina, lifestyle counseling
|
Self Care - Period 1
n=40 Participants
Self-care for TMD developed by Dworkin, LeResche et al. Self-care for TMD: a 5-session 8 hour intervention targeting TMD knowledge, stretching and exercises, stress reduction, lifestyle modification
|
Traditional Chinese Medicine - Period 2
n=42 Participants
Whole systems traditional Chinese medicine, including individually tailored herbal formulas, acupuncture, tuna (Chinese massage), lifestyle recommendations TCM: whole system Traditional Chinese Medicine, including acupuncture, herbs, tuina, lifestyle counseling
|
Self Care - Period 2
n=43 Participants
Self-care for TMD developed by Dworkin, LeResche et al. Self-care for TMD: a 5-session 8 hour intervention targeting TMD knowledge, stretching and exercises, stress reduction, lifestyle modification
|
Total
n=164 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
Period 1
|
42.9 years
STANDARD_DEVIATION 13.0 • n=39 Participants • In the 1st period, 79 subjects were allocated to TCM (39) or SC (40). 36 TCM subjects completed the 1st period; all were removed from the allocation group for the 2nd period per study plan. 35 SC subjects completed the 1st period. 29 were allocated to TCM (15) or SC (14) for the 2nd period; 6 were removed from the allocation group due to subject choice or insufficient pain. 56 additional subjects were allocated to TCM (27) or SC (29) for the 2nd period. 135 subjects total were allocated.
|
42.3 years
STANDARD_DEVIATION 13.5 • n=40 Participants • In the 1st period, 79 subjects were allocated to TCM (39) or SC (40). 36 TCM subjects completed the 1st period; all were removed from the allocation group for the 2nd period per study plan. 35 SC subjects completed the 1st period. 29 were allocated to TCM (15) or SC (14) for the 2nd period; 6 were removed from the allocation group due to subject choice or insufficient pain. 56 additional subjects were allocated to TCM (27) or SC (29) for the 2nd period. 135 subjects total were allocated.
|
—
|
—
|
42.6 years
STANDARD_DEVIATION 13.3 • n=79 Participants • In the 1st period, 79 subjects were allocated to TCM (39) or SC (40). 36 TCM subjects completed the 1st period; all were removed from the allocation group for the 2nd period per study plan. 35 SC subjects completed the 1st period. 29 were allocated to TCM (15) or SC (14) for the 2nd period; 6 were removed from the allocation group due to subject choice or insufficient pain. 56 additional subjects were allocated to TCM (27) or SC (29) for the 2nd period. 135 subjects total were allocated.
|
|
Age, Continuous
Period 2
|
—
|
—
|
43.6 years
STANDARD_DEVIATION 12.0 • n=42 Participants • In the 1st period, 79 subjects were allocated to TCM (39) or SC (40). 36 TCM subjects completed the 1st period; all were removed from the allocation group for the 2nd period per study plan. 35 SC subjects completed the 1st period. 29 were allocated to TCM (15) or SC (14) for the 2nd period; 6 were removed from the allocation group due to subject choice or insufficient pain. 56 additional subjects were allocated to TCM (27) or SC (29) for the 2nd period. 135 subjects total were allocated.
|
43.7 years
STANDARD_DEVIATION 12.4 • n=43 Participants • In the 1st period, 79 subjects were allocated to TCM (39) or SC (40). 36 TCM subjects completed the 1st period; all were removed from the allocation group for the 2nd period per study plan. 35 SC subjects completed the 1st period. 29 were allocated to TCM (15) or SC (14) for the 2nd period; 6 were removed from the allocation group due to subject choice or insufficient pain. 56 additional subjects were allocated to TCM (27) or SC (29) for the 2nd period. 135 subjects total were allocated.
|
43.65 years
STANDARD_DEVIATION 12.20 • n=85 Participants • In the 1st period, 79 subjects were allocated to TCM (39) or SC (40). 36 TCM subjects completed the 1st period; all were removed from the allocation group for the 2nd period per study plan. 35 SC subjects completed the 1st period. 29 were allocated to TCM (15) or SC (14) for the 2nd period; 6 were removed from the allocation group due to subject choice or insufficient pain. 56 additional subjects were allocated to TCM (27) or SC (29) for the 2nd period. 135 subjects total were allocated.
|
|
Sex: Female, Male
Period 1 · Female
|
34 Participants
n=39 Participants • In the 1st period, 79 subjects were allocated to TCM (39) or SC (40). 36 TCM subjects completed the 1st period; all were removed from the allocation group for the 2nd period per study plan. 35 SC subjects completed the 1st period. 29 were allocated to TCM (15) or SC (14) for the 2nd period; 6 were removed from the allocation group due to subject choice or insufficient pain. 56 additional subjects were allocated to TCM (27) or SC (29) for the 2nd period. 135 subjects total were allocated.
|
34 Participants
n=40 Participants • In the 1st period, 79 subjects were allocated to TCM (39) or SC (40). 36 TCM subjects completed the 1st period; all were removed from the allocation group for the 2nd period per study plan. 35 SC subjects completed the 1st period. 29 were allocated to TCM (15) or SC (14) for the 2nd period; 6 were removed from the allocation group due to subject choice or insufficient pain. 56 additional subjects were allocated to TCM (27) or SC (29) for the 2nd period. 135 subjects total were allocated.
|
—
|
—
|
68 Participants
n=79 Participants • In the 1st period, 79 subjects were allocated to TCM (39) or SC (40). 36 TCM subjects completed the 1st period; all were removed from the allocation group for the 2nd period per study plan. 35 SC subjects completed the 1st period. 29 were allocated to TCM (15) or SC (14) for the 2nd period; 6 were removed from the allocation group due to subject choice or insufficient pain. 56 additional subjects were allocated to TCM (27) or SC (29) for the 2nd period. 135 subjects total were allocated.
|
|
Sex: Female, Male
Period 1 · Male
|
5 Participants
n=39 Participants • In the 1st period, 79 subjects were allocated to TCM (39) or SC (40). 36 TCM subjects completed the 1st period; all were removed from the allocation group for the 2nd period per study plan. 35 SC subjects completed the 1st period. 29 were allocated to TCM (15) or SC (14) for the 2nd period; 6 were removed from the allocation group due to subject choice or insufficient pain. 56 additional subjects were allocated to TCM (27) or SC (29) for the 2nd period. 135 subjects total were allocated.
|
6 Participants
n=40 Participants • In the 1st period, 79 subjects were allocated to TCM (39) or SC (40). 36 TCM subjects completed the 1st period; all were removed from the allocation group for the 2nd period per study plan. 35 SC subjects completed the 1st period. 29 were allocated to TCM (15) or SC (14) for the 2nd period; 6 were removed from the allocation group due to subject choice or insufficient pain. 56 additional subjects were allocated to TCM (27) or SC (29) for the 2nd period. 135 subjects total were allocated.
|
—
|
—
|
11 Participants
n=79 Participants • In the 1st period, 79 subjects were allocated to TCM (39) or SC (40). 36 TCM subjects completed the 1st period; all were removed from the allocation group for the 2nd period per study plan. 35 SC subjects completed the 1st period. 29 were allocated to TCM (15) or SC (14) for the 2nd period; 6 were removed from the allocation group due to subject choice or insufficient pain. 56 additional subjects were allocated to TCM (27) or SC (29) for the 2nd period. 135 subjects total were allocated.
|
|
Sex: Female, Male
Period 2 · Female
|
—
|
—
|
37 Participants
n=42 Participants • In the 1st period, 79 subjects were allocated to TCM (39) or SC (40). 36 TCM subjects completed the 1st period; all were removed from the allocation group for the 2nd period per study plan. 35 SC subjects completed the 1st period. 29 were allocated to TCM (15) or SC (14) for the 2nd period; 6 were removed from the allocation group due to subject choice or insufficient pain. 56 additional subjects were allocated to TCM (27) or SC (29) for the 2nd period. 135 subjects total were allocated.
|
37 Participants
n=43 Participants • In the 1st period, 79 subjects were allocated to TCM (39) or SC (40). 36 TCM subjects completed the 1st period; all were removed from the allocation group for the 2nd period per study plan. 35 SC subjects completed the 1st period. 29 were allocated to TCM (15) or SC (14) for the 2nd period; 6 were removed from the allocation group due to subject choice or insufficient pain. 56 additional subjects were allocated to TCM (27) or SC (29) for the 2nd period. 135 subjects total were allocated.
|
74 Participants
n=85 Participants • In the 1st period, 79 subjects were allocated to TCM (39) or SC (40). 36 TCM subjects completed the 1st period; all were removed from the allocation group for the 2nd period per study plan. 35 SC subjects completed the 1st period. 29 were allocated to TCM (15) or SC (14) for the 2nd period; 6 were removed from the allocation group due to subject choice or insufficient pain. 56 additional subjects were allocated to TCM (27) or SC (29) for the 2nd period. 135 subjects total were allocated.
|
|
Sex: Female, Male
Period 2 · Male
|
—
|
—
|
5 Participants
n=42 Participants • In the 1st period, 79 subjects were allocated to TCM (39) or SC (40). 36 TCM subjects completed the 1st period; all were removed from the allocation group for the 2nd period per study plan. 35 SC subjects completed the 1st period. 29 were allocated to TCM (15) or SC (14) for the 2nd period; 6 were removed from the allocation group due to subject choice or insufficient pain. 56 additional subjects were allocated to TCM (27) or SC (29) for the 2nd period. 135 subjects total were allocated.
|
6 Participants
n=43 Participants • In the 1st period, 79 subjects were allocated to TCM (39) or SC (40). 36 TCM subjects completed the 1st period; all were removed from the allocation group for the 2nd period per study plan. 35 SC subjects completed the 1st period. 29 were allocated to TCM (15) or SC (14) for the 2nd period; 6 were removed from the allocation group due to subject choice or insufficient pain. 56 additional subjects were allocated to TCM (27) or SC (29) for the 2nd period. 135 subjects total were allocated.
|
11 Participants
n=85 Participants • In the 1st period, 79 subjects were allocated to TCM (39) or SC (40). 36 TCM subjects completed the 1st period; all were removed from the allocation group for the 2nd period per study plan. 35 SC subjects completed the 1st period. 29 were allocated to TCM (15) or SC (14) for the 2nd period; 6 were removed from the allocation group due to subject choice or insufficient pain. 56 additional subjects were allocated to TCM (27) or SC (29) for the 2nd period. 135 subjects total were allocated.
|
|
Ethnicity (NIH/OMB)
Period 1 · Hispanic or Latino
|
4 Participants
n=39 Participants • In the 1st period, 79 subjects were allocated to TCM (39) or SC (40). 36 TCM subjects completed the 1st period; all were removed from the allocation group for the 2nd period per study plan. 35 SC subjects completed the 1st period. 29 were allocated to TCM (15) or SC (14) for the 2nd period; 6 were removed from the allocation group due to subject choice or insufficient pain. 56 additional subjects were allocated to TCM (27) or SC (29) for the 2nd period. 135 subjects total were allocated.
|
4 Participants
n=40 Participants • In the 1st period, 79 subjects were allocated to TCM (39) or SC (40). 36 TCM subjects completed the 1st period; all were removed from the allocation group for the 2nd period per study plan. 35 SC subjects completed the 1st period. 29 were allocated to TCM (15) or SC (14) for the 2nd period; 6 were removed from the allocation group due to subject choice or insufficient pain. 56 additional subjects were allocated to TCM (27) or SC (29) for the 2nd period. 135 subjects total were allocated.
|
—
|
—
|
8 Participants
n=79 Participants • In the 1st period, 79 subjects were allocated to TCM (39) or SC (40). 36 TCM subjects completed the 1st period; all were removed from the allocation group for the 2nd period per study plan. 35 SC subjects completed the 1st period. 29 were allocated to TCM (15) or SC (14) for the 2nd period; 6 were removed from the allocation group due to subject choice or insufficient pain. 56 additional subjects were allocated to TCM (27) or SC (29) for the 2nd period. 135 subjects total were allocated.
|
|
Ethnicity (NIH/OMB)
Period 1 · Not Hispanic or Latino
|
33 Participants
n=39 Participants • In the 1st period, 79 subjects were allocated to TCM (39) or SC (40). 36 TCM subjects completed the 1st period; all were removed from the allocation group for the 2nd period per study plan. 35 SC subjects completed the 1st period. 29 were allocated to TCM (15) or SC (14) for the 2nd period; 6 were removed from the allocation group due to subject choice or insufficient pain. 56 additional subjects were allocated to TCM (27) or SC (29) for the 2nd period. 135 subjects total were allocated.
|
34 Participants
n=40 Participants • In the 1st period, 79 subjects were allocated to TCM (39) or SC (40). 36 TCM subjects completed the 1st period; all were removed from the allocation group for the 2nd period per study plan. 35 SC subjects completed the 1st period. 29 were allocated to TCM (15) or SC (14) for the 2nd period; 6 were removed from the allocation group due to subject choice or insufficient pain. 56 additional subjects were allocated to TCM (27) or SC (29) for the 2nd period. 135 subjects total were allocated.
|
—
|
—
|
67 Participants
n=79 Participants • In the 1st period, 79 subjects were allocated to TCM (39) or SC (40). 36 TCM subjects completed the 1st period; all were removed from the allocation group for the 2nd period per study plan. 35 SC subjects completed the 1st period. 29 were allocated to TCM (15) or SC (14) for the 2nd period; 6 were removed from the allocation group due to subject choice or insufficient pain. 56 additional subjects were allocated to TCM (27) or SC (29) for the 2nd period. 135 subjects total were allocated.
|
|
Ethnicity (NIH/OMB)
Period 1 · Unknown or Not Reported
|
2 Participants
n=39 Participants • In the 1st period, 79 subjects were allocated to TCM (39) or SC (40). 36 TCM subjects completed the 1st period; all were removed from the allocation group for the 2nd period per study plan. 35 SC subjects completed the 1st period. 29 were allocated to TCM (15) or SC (14) for the 2nd period; 6 were removed from the allocation group due to subject choice or insufficient pain. 56 additional subjects were allocated to TCM (27) or SC (29) for the 2nd period. 135 subjects total were allocated.
|
2 Participants
n=40 Participants • In the 1st period, 79 subjects were allocated to TCM (39) or SC (40). 36 TCM subjects completed the 1st period; all were removed from the allocation group for the 2nd period per study plan. 35 SC subjects completed the 1st period. 29 were allocated to TCM (15) or SC (14) for the 2nd period; 6 were removed from the allocation group due to subject choice or insufficient pain. 56 additional subjects were allocated to TCM (27) or SC (29) for the 2nd period. 135 subjects total were allocated.
|
—
|
—
|
4 Participants
n=79 Participants • In the 1st period, 79 subjects were allocated to TCM (39) or SC (40). 36 TCM subjects completed the 1st period; all were removed from the allocation group for the 2nd period per study plan. 35 SC subjects completed the 1st period. 29 were allocated to TCM (15) or SC (14) for the 2nd period; 6 were removed from the allocation group due to subject choice or insufficient pain. 56 additional subjects were allocated to TCM (27) or SC (29) for the 2nd period. 135 subjects total were allocated.
|
|
Ethnicity (NIH/OMB)
Period 2 · Hispanic or Latino
|
—
|
—
|
5 Participants
n=42 Participants • In the 1st period, 79 subjects were allocated to TCM (39) or SC (40). 36 TCM subjects completed the 1st period; all were removed from the allocation group for the 2nd period per study plan. 35 SC subjects completed the 1st period. 29 were allocated to TCM (15) or SC (14) for the 2nd period; 6 were removed from the allocation group due to subject choice or insufficient pain. 56 additional subjects were allocated to TCM (27) or SC (29) for the 2nd period. 135 subjects total were allocated.
|
5 Participants
n=43 Participants • In the 1st period, 79 subjects were allocated to TCM (39) or SC (40). 36 TCM subjects completed the 1st period; all were removed from the allocation group for the 2nd period per study plan. 35 SC subjects completed the 1st period. 29 were allocated to TCM (15) or SC (14) for the 2nd period; 6 were removed from the allocation group due to subject choice or insufficient pain. 56 additional subjects were allocated to TCM (27) or SC (29) for the 2nd period. 135 subjects total were allocated.
|
10 Participants
n=85 Participants • In the 1st period, 79 subjects were allocated to TCM (39) or SC (40). 36 TCM subjects completed the 1st period; all were removed from the allocation group for the 2nd period per study plan. 35 SC subjects completed the 1st period. 29 were allocated to TCM (15) or SC (14) for the 2nd period; 6 were removed from the allocation group due to subject choice or insufficient pain. 56 additional subjects were allocated to TCM (27) or SC (29) for the 2nd period. 135 subjects total were allocated.
|
|
Ethnicity (NIH/OMB)
Period 2 · Not Hispanic or Latino
|
—
|
—
|
35 Participants
n=42 Participants • In the 1st period, 79 subjects were allocated to TCM (39) or SC (40). 36 TCM subjects completed the 1st period; all were removed from the allocation group for the 2nd period per study plan. 35 SC subjects completed the 1st period. 29 were allocated to TCM (15) or SC (14) for the 2nd period; 6 were removed from the allocation group due to subject choice or insufficient pain. 56 additional subjects were allocated to TCM (27) or SC (29) for the 2nd period. 135 subjects total were allocated.
|
38 Participants
n=43 Participants • In the 1st period, 79 subjects were allocated to TCM (39) or SC (40). 36 TCM subjects completed the 1st period; all were removed from the allocation group for the 2nd period per study plan. 35 SC subjects completed the 1st period. 29 were allocated to TCM (15) or SC (14) for the 2nd period; 6 were removed from the allocation group due to subject choice or insufficient pain. 56 additional subjects were allocated to TCM (27) or SC (29) for the 2nd period. 135 subjects total were allocated.
|
73 Participants
n=85 Participants • In the 1st period, 79 subjects were allocated to TCM (39) or SC (40). 36 TCM subjects completed the 1st period; all were removed from the allocation group for the 2nd period per study plan. 35 SC subjects completed the 1st period. 29 were allocated to TCM (15) or SC (14) for the 2nd period; 6 were removed from the allocation group due to subject choice or insufficient pain. 56 additional subjects were allocated to TCM (27) or SC (29) for the 2nd period. 135 subjects total were allocated.
|
|
Ethnicity (NIH/OMB)
Period 2 · Unknown or Not Reported
|
—
|
—
|
2 Participants
n=42 Participants • In the 1st period, 79 subjects were allocated to TCM (39) or SC (40). 36 TCM subjects completed the 1st period; all were removed from the allocation group for the 2nd period per study plan. 35 SC subjects completed the 1st period. 29 were allocated to TCM (15) or SC (14) for the 2nd period; 6 were removed from the allocation group due to subject choice or insufficient pain. 56 additional subjects were allocated to TCM (27) or SC (29) for the 2nd period. 135 subjects total were allocated.
|
0 Participants
n=43 Participants • In the 1st period, 79 subjects were allocated to TCM (39) or SC (40). 36 TCM subjects completed the 1st period; all were removed from the allocation group for the 2nd period per study plan. 35 SC subjects completed the 1st period. 29 were allocated to TCM (15) or SC (14) for the 2nd period; 6 were removed from the allocation group due to subject choice or insufficient pain. 56 additional subjects were allocated to TCM (27) or SC (29) for the 2nd period. 135 subjects total were allocated.
|
2 Participants
n=85 Participants • In the 1st period, 79 subjects were allocated to TCM (39) or SC (40). 36 TCM subjects completed the 1st period; all were removed from the allocation group for the 2nd period per study plan. 35 SC subjects completed the 1st period. 29 were allocated to TCM (15) or SC (14) for the 2nd period; 6 were removed from the allocation group due to subject choice or insufficient pain. 56 additional subjects were allocated to TCM (27) or SC (29) for the 2nd period. 135 subjects total were allocated.
|
|
Race (NIH/OMB)
Period 1 · American Indian or Alaska Native
|
0 Participants
n=39 Participants • In the 1st period, 79 subjects were allocated to TCM (39) or SC (40). 36 TCM subjects completed the 1st period; all were removed from the allocation group for the 2nd period per study plan. 35 SC subjects completed the 1st period. 29 were allocated to TCM (15) or SC (14) for the 2nd period; 6 were removed from the allocation group due to subject choice or insufficient pain. 56 additional subjects were allocated to TCM (27) or SC (29) for the 2nd period. 135 subjects total were allocated.
|
0 Participants
n=40 Participants • In the 1st period, 79 subjects were allocated to TCM (39) or SC (40). 36 TCM subjects completed the 1st period; all were removed from the allocation group for the 2nd period per study plan. 35 SC subjects completed the 1st period. 29 were allocated to TCM (15) or SC (14) for the 2nd period; 6 were removed from the allocation group due to subject choice or insufficient pain. 56 additional subjects were allocated to TCM (27) or SC (29) for the 2nd period. 135 subjects total were allocated.
|
—
|
—
|
0 Participants
n=79 Participants • In the 1st period, 79 subjects were allocated to TCM (39) or SC (40). 36 TCM subjects completed the 1st period; all were removed from the allocation group for the 2nd period per study plan. 35 SC subjects completed the 1st period. 29 were allocated to TCM (15) or SC (14) for the 2nd period; 6 were removed from the allocation group due to subject choice or insufficient pain. 56 additional subjects were allocated to TCM (27) or SC (29) for the 2nd period. 135 subjects total were allocated.
|
|
Race (NIH/OMB)
Period 1 · Asian
|
1 Participants
n=39 Participants • In the 1st period, 79 subjects were allocated to TCM (39) or SC (40). 36 TCM subjects completed the 1st period; all were removed from the allocation group for the 2nd period per study plan. 35 SC subjects completed the 1st period. 29 were allocated to TCM (15) or SC (14) for the 2nd period; 6 were removed from the allocation group due to subject choice or insufficient pain. 56 additional subjects were allocated to TCM (27) or SC (29) for the 2nd period. 135 subjects total were allocated.
|
0 Participants
n=40 Participants • In the 1st period, 79 subjects were allocated to TCM (39) or SC (40). 36 TCM subjects completed the 1st period; all were removed from the allocation group for the 2nd period per study plan. 35 SC subjects completed the 1st period. 29 were allocated to TCM (15) or SC (14) for the 2nd period; 6 were removed from the allocation group due to subject choice or insufficient pain. 56 additional subjects were allocated to TCM (27) or SC (29) for the 2nd period. 135 subjects total were allocated.
|
—
|
—
|
1 Participants
n=79 Participants • In the 1st period, 79 subjects were allocated to TCM (39) or SC (40). 36 TCM subjects completed the 1st period; all were removed from the allocation group for the 2nd period per study plan. 35 SC subjects completed the 1st period. 29 were allocated to TCM (15) or SC (14) for the 2nd period; 6 were removed from the allocation group due to subject choice or insufficient pain. 56 additional subjects were allocated to TCM (27) or SC (29) for the 2nd period. 135 subjects total were allocated.
|
|
Race (NIH/OMB)
Period 1 · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants • In the 1st period, 79 subjects were allocated to TCM (39) or SC (40). 36 TCM subjects completed the 1st period; all were removed from the allocation group for the 2nd period per study plan. 35 SC subjects completed the 1st period. 29 were allocated to TCM (15) or SC (14) for the 2nd period; 6 were removed from the allocation group due to subject choice or insufficient pain. 56 additional subjects were allocated to TCM (27) or SC (29) for the 2nd period. 135 subjects total were allocated.
|
0 Participants
n=40 Participants • In the 1st period, 79 subjects were allocated to TCM (39) or SC (40). 36 TCM subjects completed the 1st period; all were removed from the allocation group for the 2nd period per study plan. 35 SC subjects completed the 1st period. 29 were allocated to TCM (15) or SC (14) for the 2nd period; 6 were removed from the allocation group due to subject choice or insufficient pain. 56 additional subjects were allocated to TCM (27) or SC (29) for the 2nd period. 135 subjects total were allocated.
|
—
|
—
|
0 Participants
n=79 Participants • In the 1st period, 79 subjects were allocated to TCM (39) or SC (40). 36 TCM subjects completed the 1st period; all were removed from the allocation group for the 2nd period per study plan. 35 SC subjects completed the 1st period. 29 were allocated to TCM (15) or SC (14) for the 2nd period; 6 were removed from the allocation group due to subject choice or insufficient pain. 56 additional subjects were allocated to TCM (27) or SC (29) for the 2nd period. 135 subjects total were allocated.
|
|
Race (NIH/OMB)
Period 1 · Black or African American
|
1 Participants
n=39 Participants • In the 1st period, 79 subjects were allocated to TCM (39) or SC (40). 36 TCM subjects completed the 1st period; all were removed from the allocation group for the 2nd period per study plan. 35 SC subjects completed the 1st period. 29 were allocated to TCM (15) or SC (14) for the 2nd period; 6 were removed from the allocation group due to subject choice or insufficient pain. 56 additional subjects were allocated to TCM (27) or SC (29) for the 2nd period. 135 subjects total were allocated.
|
1 Participants
n=40 Participants • In the 1st period, 79 subjects were allocated to TCM (39) or SC (40). 36 TCM subjects completed the 1st period; all were removed from the allocation group for the 2nd period per study plan. 35 SC subjects completed the 1st period. 29 were allocated to TCM (15) or SC (14) for the 2nd period; 6 were removed from the allocation group due to subject choice or insufficient pain. 56 additional subjects were allocated to TCM (27) or SC (29) for the 2nd period. 135 subjects total were allocated.
|
—
|
—
|
2 Participants
n=79 Participants • In the 1st period, 79 subjects were allocated to TCM (39) or SC (40). 36 TCM subjects completed the 1st period; all were removed from the allocation group for the 2nd period per study plan. 35 SC subjects completed the 1st period. 29 were allocated to TCM (15) or SC (14) for the 2nd period; 6 were removed from the allocation group due to subject choice or insufficient pain. 56 additional subjects were allocated to TCM (27) or SC (29) for the 2nd period. 135 subjects total were allocated.
|
|
Race (NIH/OMB)
Period 1 · White
|
33 Participants
n=39 Participants • In the 1st period, 79 subjects were allocated to TCM (39) or SC (40). 36 TCM subjects completed the 1st period; all were removed from the allocation group for the 2nd period per study plan. 35 SC subjects completed the 1st period. 29 were allocated to TCM (15) or SC (14) for the 2nd period; 6 were removed from the allocation group due to subject choice or insufficient pain. 56 additional subjects were allocated to TCM (27) or SC (29) for the 2nd period. 135 subjects total were allocated.
|
33 Participants
n=40 Participants • In the 1st period, 79 subjects were allocated to TCM (39) or SC (40). 36 TCM subjects completed the 1st period; all were removed from the allocation group for the 2nd period per study plan. 35 SC subjects completed the 1st period. 29 were allocated to TCM (15) or SC (14) for the 2nd period; 6 were removed from the allocation group due to subject choice or insufficient pain. 56 additional subjects were allocated to TCM (27) or SC (29) for the 2nd period. 135 subjects total were allocated.
|
—
|
—
|
66 Participants
n=79 Participants • In the 1st period, 79 subjects were allocated to TCM (39) or SC (40). 36 TCM subjects completed the 1st period; all were removed from the allocation group for the 2nd period per study plan. 35 SC subjects completed the 1st period. 29 were allocated to TCM (15) or SC (14) for the 2nd period; 6 were removed from the allocation group due to subject choice or insufficient pain. 56 additional subjects were allocated to TCM (27) or SC (29) for the 2nd period. 135 subjects total were allocated.
|
|
Race (NIH/OMB)
Period 1 · More than one race
|
1 Participants
n=39 Participants • In the 1st period, 79 subjects were allocated to TCM (39) or SC (40). 36 TCM subjects completed the 1st period; all were removed from the allocation group for the 2nd period per study plan. 35 SC subjects completed the 1st period. 29 were allocated to TCM (15) or SC (14) for the 2nd period; 6 were removed from the allocation group due to subject choice or insufficient pain. 56 additional subjects were allocated to TCM (27) or SC (29) for the 2nd period. 135 subjects total were allocated.
|
1 Participants
n=40 Participants • In the 1st period, 79 subjects were allocated to TCM (39) or SC (40). 36 TCM subjects completed the 1st period; all were removed from the allocation group for the 2nd period per study plan. 35 SC subjects completed the 1st period. 29 were allocated to TCM (15) or SC (14) for the 2nd period; 6 were removed from the allocation group due to subject choice or insufficient pain. 56 additional subjects were allocated to TCM (27) or SC (29) for the 2nd period. 135 subjects total were allocated.
|
—
|
—
|
2 Participants
n=79 Participants • In the 1st period, 79 subjects were allocated to TCM (39) or SC (40). 36 TCM subjects completed the 1st period; all were removed from the allocation group for the 2nd period per study plan. 35 SC subjects completed the 1st period. 29 were allocated to TCM (15) or SC (14) for the 2nd period; 6 were removed from the allocation group due to subject choice or insufficient pain. 56 additional subjects were allocated to TCM (27) or SC (29) for the 2nd period. 135 subjects total were allocated.
|
|
Race (NIH/OMB)
Period 1 · Unknown or Not Reported
|
3 Participants
n=39 Participants • In the 1st period, 79 subjects were allocated to TCM (39) or SC (40). 36 TCM subjects completed the 1st period; all were removed from the allocation group for the 2nd period per study plan. 35 SC subjects completed the 1st period. 29 were allocated to TCM (15) or SC (14) for the 2nd period; 6 were removed from the allocation group due to subject choice or insufficient pain. 56 additional subjects were allocated to TCM (27) or SC (29) for the 2nd period. 135 subjects total were allocated.
|
5 Participants
n=40 Participants • In the 1st period, 79 subjects were allocated to TCM (39) or SC (40). 36 TCM subjects completed the 1st period; all were removed from the allocation group for the 2nd period per study plan. 35 SC subjects completed the 1st period. 29 were allocated to TCM (15) or SC (14) for the 2nd period; 6 were removed from the allocation group due to subject choice or insufficient pain. 56 additional subjects were allocated to TCM (27) or SC (29) for the 2nd period. 135 subjects total were allocated.
|
—
|
—
|
8 Participants
n=79 Participants • In the 1st period, 79 subjects were allocated to TCM (39) or SC (40). 36 TCM subjects completed the 1st period; all were removed from the allocation group for the 2nd period per study plan. 35 SC subjects completed the 1st period. 29 were allocated to TCM (15) or SC (14) for the 2nd period; 6 were removed from the allocation group due to subject choice or insufficient pain. 56 additional subjects were allocated to TCM (27) or SC (29) for the 2nd period. 135 subjects total were allocated.
|
|
Race (NIH/OMB)
Period 2 · American Indian or Alaska Native
|
—
|
—
|
0 Participants
n=42 Participants • In the 1st period, 79 subjects were allocated to TCM (39) or SC (40). 36 TCM subjects completed the 1st period; all were removed from the allocation group for the 2nd period per study plan. 35 SC subjects completed the 1st period. 29 were allocated to TCM (15) or SC (14) for the 2nd period; 6 were removed from the allocation group due to subject choice or insufficient pain. 56 additional subjects were allocated to TCM (27) or SC (29) for the 2nd period. 135 subjects total were allocated.
|
0 Participants
n=43 Participants • In the 1st period, 79 subjects were allocated to TCM (39) or SC (40). 36 TCM subjects completed the 1st period; all were removed from the allocation group for the 2nd period per study plan. 35 SC subjects completed the 1st period. 29 were allocated to TCM (15) or SC (14) for the 2nd period; 6 were removed from the allocation group due to subject choice or insufficient pain. 56 additional subjects were allocated to TCM (27) or SC (29) for the 2nd period. 135 subjects total were allocated.
|
0 Participants
n=85 Participants • In the 1st period, 79 subjects were allocated to TCM (39) or SC (40). 36 TCM subjects completed the 1st period; all were removed from the allocation group for the 2nd period per study plan. 35 SC subjects completed the 1st period. 29 were allocated to TCM (15) or SC (14) for the 2nd period; 6 were removed from the allocation group due to subject choice or insufficient pain. 56 additional subjects were allocated to TCM (27) or SC (29) for the 2nd period. 135 subjects total were allocated.
|
|
Race (NIH/OMB)
Period 2 · Asian
|
—
|
—
|
0 Participants
n=42 Participants • In the 1st period, 79 subjects were allocated to TCM (39) or SC (40). 36 TCM subjects completed the 1st period; all were removed from the allocation group for the 2nd period per study plan. 35 SC subjects completed the 1st period. 29 were allocated to TCM (15) or SC (14) for the 2nd period; 6 were removed from the allocation group due to subject choice or insufficient pain. 56 additional subjects were allocated to TCM (27) or SC (29) for the 2nd period. 135 subjects total were allocated.
|
0 Participants
n=43 Participants • In the 1st period, 79 subjects were allocated to TCM (39) or SC (40). 36 TCM subjects completed the 1st period; all were removed from the allocation group for the 2nd period per study plan. 35 SC subjects completed the 1st period. 29 were allocated to TCM (15) or SC (14) for the 2nd period; 6 were removed from the allocation group due to subject choice or insufficient pain. 56 additional subjects were allocated to TCM (27) or SC (29) for the 2nd period. 135 subjects total were allocated.
|
0 Participants
n=85 Participants • In the 1st period, 79 subjects were allocated to TCM (39) or SC (40). 36 TCM subjects completed the 1st period; all were removed from the allocation group for the 2nd period per study plan. 35 SC subjects completed the 1st period. 29 were allocated to TCM (15) or SC (14) for the 2nd period; 6 were removed from the allocation group due to subject choice or insufficient pain. 56 additional subjects were allocated to TCM (27) or SC (29) for the 2nd period. 135 subjects total were allocated.
|
|
Race (NIH/OMB)
Period 2 · Native Hawaiian or Other Pacific Islander
|
—
|
—
|
0 Participants
n=42 Participants • In the 1st period, 79 subjects were allocated to TCM (39) or SC (40). 36 TCM subjects completed the 1st period; all were removed from the allocation group for the 2nd period per study plan. 35 SC subjects completed the 1st period. 29 were allocated to TCM (15) or SC (14) for the 2nd period; 6 were removed from the allocation group due to subject choice or insufficient pain. 56 additional subjects were allocated to TCM (27) or SC (29) for the 2nd period. 135 subjects total were allocated.
|
0 Participants
n=43 Participants • In the 1st period, 79 subjects were allocated to TCM (39) or SC (40). 36 TCM subjects completed the 1st period; all were removed from the allocation group for the 2nd period per study plan. 35 SC subjects completed the 1st period. 29 were allocated to TCM (15) or SC (14) for the 2nd period; 6 were removed from the allocation group due to subject choice or insufficient pain. 56 additional subjects were allocated to TCM (27) or SC (29) for the 2nd period. 135 subjects total were allocated.
|
0 Participants
n=85 Participants • In the 1st period, 79 subjects were allocated to TCM (39) or SC (40). 36 TCM subjects completed the 1st period; all were removed from the allocation group for the 2nd period per study plan. 35 SC subjects completed the 1st period. 29 were allocated to TCM (15) or SC (14) for the 2nd period; 6 were removed from the allocation group due to subject choice or insufficient pain. 56 additional subjects were allocated to TCM (27) or SC (29) for the 2nd period. 135 subjects total were allocated.
|
|
Race (NIH/OMB)
Period 2 · Black or African American
|
—
|
—
|
0 Participants
n=42 Participants • In the 1st period, 79 subjects were allocated to TCM (39) or SC (40). 36 TCM subjects completed the 1st period; all were removed from the allocation group for the 2nd period per study plan. 35 SC subjects completed the 1st period. 29 were allocated to TCM (15) or SC (14) for the 2nd period; 6 were removed from the allocation group due to subject choice or insufficient pain. 56 additional subjects were allocated to TCM (27) or SC (29) for the 2nd period. 135 subjects total were allocated.
|
0 Participants
n=43 Participants • In the 1st period, 79 subjects were allocated to TCM (39) or SC (40). 36 TCM subjects completed the 1st period; all were removed from the allocation group for the 2nd period per study plan. 35 SC subjects completed the 1st period. 29 were allocated to TCM (15) or SC (14) for the 2nd period; 6 were removed from the allocation group due to subject choice or insufficient pain. 56 additional subjects were allocated to TCM (27) or SC (29) for the 2nd period. 135 subjects total were allocated.
|
0 Participants
n=85 Participants • In the 1st period, 79 subjects were allocated to TCM (39) or SC (40). 36 TCM subjects completed the 1st period; all were removed from the allocation group for the 2nd period per study plan. 35 SC subjects completed the 1st period. 29 were allocated to TCM (15) or SC (14) for the 2nd period; 6 were removed from the allocation group due to subject choice or insufficient pain. 56 additional subjects were allocated to TCM (27) or SC (29) for the 2nd period. 135 subjects total were allocated.
|
|
Race (NIH/OMB)
Period 2 · White
|
—
|
—
|
35 Participants
n=42 Participants • In the 1st period, 79 subjects were allocated to TCM (39) or SC (40). 36 TCM subjects completed the 1st period; all were removed from the allocation group for the 2nd period per study plan. 35 SC subjects completed the 1st period. 29 were allocated to TCM (15) or SC (14) for the 2nd period; 6 were removed from the allocation group due to subject choice or insufficient pain. 56 additional subjects were allocated to TCM (27) or SC (29) for the 2nd period. 135 subjects total were allocated.
|
37 Participants
n=43 Participants • In the 1st period, 79 subjects were allocated to TCM (39) or SC (40). 36 TCM subjects completed the 1st period; all were removed from the allocation group for the 2nd period per study plan. 35 SC subjects completed the 1st period. 29 were allocated to TCM (15) or SC (14) for the 2nd period; 6 were removed from the allocation group due to subject choice or insufficient pain. 56 additional subjects were allocated to TCM (27) or SC (29) for the 2nd period. 135 subjects total were allocated.
|
72 Participants
n=85 Participants • In the 1st period, 79 subjects were allocated to TCM (39) or SC (40). 36 TCM subjects completed the 1st period; all were removed from the allocation group for the 2nd period per study plan. 35 SC subjects completed the 1st period. 29 were allocated to TCM (15) or SC (14) for the 2nd period; 6 were removed from the allocation group due to subject choice or insufficient pain. 56 additional subjects were allocated to TCM (27) or SC (29) for the 2nd period. 135 subjects total were allocated.
|
|
Race (NIH/OMB)
Period 2 · More than one race
|
—
|
—
|
0 Participants
n=42 Participants • In the 1st period, 79 subjects were allocated to TCM (39) or SC (40). 36 TCM subjects completed the 1st period; all were removed from the allocation group for the 2nd period per study plan. 35 SC subjects completed the 1st period. 29 were allocated to TCM (15) or SC (14) for the 2nd period; 6 were removed from the allocation group due to subject choice or insufficient pain. 56 additional subjects were allocated to TCM (27) or SC (29) for the 2nd period. 135 subjects total were allocated.
|
0 Participants
n=43 Participants • In the 1st period, 79 subjects were allocated to TCM (39) or SC (40). 36 TCM subjects completed the 1st period; all were removed from the allocation group for the 2nd period per study plan. 35 SC subjects completed the 1st period. 29 were allocated to TCM (15) or SC (14) for the 2nd period; 6 were removed from the allocation group due to subject choice or insufficient pain. 56 additional subjects were allocated to TCM (27) or SC (29) for the 2nd period. 135 subjects total were allocated.
|
0 Participants
n=85 Participants • In the 1st period, 79 subjects were allocated to TCM (39) or SC (40). 36 TCM subjects completed the 1st period; all were removed from the allocation group for the 2nd period per study plan. 35 SC subjects completed the 1st period. 29 were allocated to TCM (15) or SC (14) for the 2nd period; 6 were removed from the allocation group due to subject choice or insufficient pain. 56 additional subjects were allocated to TCM (27) or SC (29) for the 2nd period. 135 subjects total were allocated.
|
|
Race (NIH/OMB)
Period 2 · Unknown or Not Reported
|
—
|
—
|
7 Participants
n=42 Participants • In the 1st period, 79 subjects were allocated to TCM (39) or SC (40). 36 TCM subjects completed the 1st period; all were removed from the allocation group for the 2nd period per study plan. 35 SC subjects completed the 1st period. 29 were allocated to TCM (15) or SC (14) for the 2nd period; 6 were removed from the allocation group due to subject choice or insufficient pain. 56 additional subjects were allocated to TCM (27) or SC (29) for the 2nd period. 135 subjects total were allocated.
|
6 Participants
n=43 Participants • In the 1st period, 79 subjects were allocated to TCM (39) or SC (40). 36 TCM subjects completed the 1st period; all were removed from the allocation group for the 2nd period per study plan. 35 SC subjects completed the 1st period. 29 were allocated to TCM (15) or SC (14) for the 2nd period; 6 were removed from the allocation group due to subject choice or insufficient pain. 56 additional subjects were allocated to TCM (27) or SC (29) for the 2nd period. 135 subjects total were allocated.
|
13 Participants
n=85 Participants • In the 1st period, 79 subjects were allocated to TCM (39) or SC (40). 36 TCM subjects completed the 1st period; all were removed from the allocation group for the 2nd period per study plan. 35 SC subjects completed the 1st period. 29 were allocated to TCM (15) or SC (14) for the 2nd period; 6 were removed from the allocation group due to subject choice or insufficient pain. 56 additional subjects were allocated to TCM (27) or SC (29) for the 2nd period. 135 subjects total were allocated.
|
|
Region of Enrollment
United States
|
39 participants
n=39 Participants • In the 1st period, 79 subjects were allocated to TCM (39) or SC (40). 36 TCM subjects completed the 1st period; all were removed from the allocation group for the 2nd period per study plan. 35 SC subjects completed the 1st period. 29 were allocated to TCM (15) or SC (14) for the 2nd period; 6 were removed from the allocation group due to subject choice or insufficient pain. 56 additional subjects were allocated to TCM (27) or SC (29) for the 2nd period. 135 subjects total were allocated.
|
40 participants
n=40 Participants • In the 1st period, 79 subjects were allocated to TCM (39) or SC (40). 36 TCM subjects completed the 1st period; all were removed from the allocation group for the 2nd period per study plan. 35 SC subjects completed the 1st period. 29 were allocated to TCM (15) or SC (14) for the 2nd period; 6 were removed from the allocation group due to subject choice or insufficient pain. 56 additional subjects were allocated to TCM (27) or SC (29) for the 2nd period. 135 subjects total were allocated.
|
42 participants
n=42 Participants • In the 1st period, 79 subjects were allocated to TCM (39) or SC (40). 36 TCM subjects completed the 1st period; all were removed from the allocation group for the 2nd period per study plan. 35 SC subjects completed the 1st period. 29 were allocated to TCM (15) or SC (14) for the 2nd period; 6 were removed from the allocation group due to subject choice or insufficient pain. 56 additional subjects were allocated to TCM (27) or SC (29) for the 2nd period. 135 subjects total were allocated.
|
43 participants
n=43 Participants • In the 1st period, 79 subjects were allocated to TCM (39) or SC (40). 36 TCM subjects completed the 1st period; all were removed from the allocation group for the 2nd period per study plan. 35 SC subjects completed the 1st period. 29 were allocated to TCM (15) or SC (14) for the 2nd period; 6 were removed from the allocation group due to subject choice or insufficient pain. 56 additional subjects were allocated to TCM (27) or SC (29) for the 2nd period. 135 subjects total were allocated.
|
85 participants
n=85 Participants • In the 1st period, 79 subjects were allocated to TCM (39) or SC (40). 36 TCM subjects completed the 1st period; all were removed from the allocation group for the 2nd period per study plan. 35 SC subjects completed the 1st period. 29 were allocated to TCM (15) or SC (14) for the 2nd period; 6 were removed from the allocation group due to subject choice or insufficient pain. 56 additional subjects were allocated to TCM (27) or SC (29) for the 2nd period. 135 subjects total were allocated.
|
PRIMARY outcome
Timeframe: Beginning of each treatment period, end of each treatment period (8 weeks later)Population: In the 1st period, 79 subjects were allocated to TCM (39) or SC (40). 36 TCM subjects completed the 1st period; all were removed from the allocation group for the 2nd period per study plan. 35 SC subjects completed the 1st period. 29 were allocated to TCM (15) or SC (14) for the 2nd period; 6 were removed from the allocation group due to subject choice or insufficient pain. 56 additional subjects were allocated to TCM (27) or SC (29) for the 2nd period. 135 subjects total were allocated.
The Characteristic Facial Pain (CFP) score is a mean of participant-reported worst pain over the previous two weeks, average pain when having pain over the previous two weeks, and current pain, reported on a 0-10 VAS scale where 0 means no pain and 10 means worst possible pain.
Outcome measures
| Measure |
Traditional Chinese Medicine - Period 1
n=36 Participants
Whole systems traditional Chinese medicine, including individually tailored herbal formulas, acupuncture, tuna (Chinese massage), lifestyle recommendations
TCM: whole system Traditional Chinese Medicine, including acupuncture, herbs, tuina, lifestyle counseling
|
Self-care - Period 1
n=35 Participants
Self-care for TMD developed by Dworkin, LeResche et al.
Self-care for TMD: a 5-session 8 hour intervention targeting TMD knowledge, stretching and exercises, stress reduction, lifestyle modification
|
Traditional Chinese Medicine - Period 2
n=37 Participants
Whole systems traditional Chinese medicine, including individually tailored herbal formulas, acupuncture, tuna (Chinese massage), lifestyle recommendations
TCM: whole system Traditional Chinese Medicine, including acupuncture, herbs, tuina, lifestyle counseling
|
Self Care - Period 2
n=38 Participants
Self-care for TMD developed by Dworkin, LeResche et al.
Self-care for TMD: a 5-session 8 hour intervention targeting TMD knowledge, stretching and exercises, stress reduction, lifestyle modification
|
|---|---|---|---|---|
|
Characteristic Facial Pain Score
Period 1 - Post-treatment
|
5.11 units on a scale
Standard Deviation 1.70
|
5.47 units on a scale
Standard Deviation 2.09
|
—
|
—
|
|
Characteristic Facial Pain Score
Period 1 - Pre-treatment
|
6.52 units on a scale
Standard Deviation 1.24
|
6.55 units on a scale
Standard Deviation 1.40
|
—
|
—
|
|
Characteristic Facial Pain Score
Period 2 - Pre-treatment
|
—
|
—
|
5.34 units on a scale
Standard Deviation 1.54
|
5.22 units on a scale
Standard Deviation 1.43
|
|
Characteristic Facial Pain Score
Period 2 - Post-treatment
|
—
|
—
|
4.44 units on a scale
Standard Deviation 1.70
|
4.93 units on a scale
Standard Deviation 1.54
|
Adverse Events
Traditional Chinese Medicine - Period 1
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Self-care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Traditional Chinese Medicine - Period 2
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Self Care - Period 2
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Traditional Chinese Medicine - Period 1
n=39 participants at risk
Whole systems traditional Chinese medicine, including herbal formulas, acupuncture, tuna (Chinese massage), lifestyle recommendations
Traditional Chinese Medicine: Whole systems traditional Chinese medicine, including individually tailored herbal formulas based on a formulary, acupuncture (based on individual TCM diagnoses), tuna (Chinese massage), lifestyle recommendations
|
Self-care
n=40 participants at risk
Self-care for TMD developed by Dworkin, LeResche et al.
Self-care for TMD: a 5-session 8 hour intervention targeting TMD knowledge, stretching and exercises, stress reduction, lifestyle modification
|
Traditional Chinese Medicine - Period 2
n=43 participants at risk
Whole systems traditional Chinese medicine, including herbal formulas, acupuncture, tuna (Chinese massage), lifestyle recommendations
Traditional Chinese Medicine: Whole systems traditional Chinese medicine, including individually tailored herbal formulas based on a formulary, acupuncture (based on individual TCM diagnoses), tuna (Chinese massage), lifestyle recommendations
|
Self Care - Period 2
n=42 participants at risk
Self-care for TMD developed by Dworkin, LeResche et al.
Self-care for TMD: a 5-session 8 hour intervention targeting TMD knowledge, stretching and exercises, stress reduction, lifestyle modification
|
|---|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Ear cellulitis
|
2.6%
1/39 • Number of events 1 • Adverse events were solicited at every regular data collection to six months beyond completion of any treatment; all practitioners had forms to use for any adverse event at a treatment session.
Symptoms were monitored per DSMB to locate possible harms, using a checklist of 24 that might be from herbs, acupuncture, lifestyle changes, recommended self-care, and as new; severity; treatment-related; change since previous. Response protocols were in place. Each DSMB reviewed patterns x intervention. Ppts reported use of emergency rooms or hospital admissions since prior query. Every "yes" required follow-up. All final decisions were by medical directors consensus with PI /DSMB concurrence.
|
0.00%
0/40 • Adverse events were solicited at every regular data collection to six months beyond completion of any treatment; all practitioners had forms to use for any adverse event at a treatment session.
Symptoms were monitored per DSMB to locate possible harms, using a checklist of 24 that might be from herbs, acupuncture, lifestyle changes, recommended self-care, and as new; severity; treatment-related; change since previous. Response protocols were in place. Each DSMB reviewed patterns x intervention. Ppts reported use of emergency rooms or hospital admissions since prior query. Every "yes" required follow-up. All final decisions were by medical directors consensus with PI /DSMB concurrence.
|
0.00%
0/43 • Adverse events were solicited at every regular data collection to six months beyond completion of any treatment; all practitioners had forms to use for any adverse event at a treatment session.
Symptoms were monitored per DSMB to locate possible harms, using a checklist of 24 that might be from herbs, acupuncture, lifestyle changes, recommended self-care, and as new; severity; treatment-related; change since previous. Response protocols were in place. Each DSMB reviewed patterns x intervention. Ppts reported use of emergency rooms or hospital admissions since prior query. Every "yes" required follow-up. All final decisions were by medical directors consensus with PI /DSMB concurrence.
|
0.00%
0/42 • Adverse events were solicited at every regular data collection to six months beyond completion of any treatment; all practitioners had forms to use for any adverse event at a treatment session.
Symptoms were monitored per DSMB to locate possible harms, using a checklist of 24 that might be from herbs, acupuncture, lifestyle changes, recommended self-care, and as new; severity; treatment-related; change since previous. Response protocols were in place. Each DSMB reviewed patterns x intervention. Ppts reported use of emergency rooms or hospital admissions since prior query. Every "yes" required follow-up. All final decisions were by medical directors consensus with PI /DSMB concurrence.
|
Additional Information
Dr. Cheryl Ritenbaugh, Principal Investigator
University of Arizona
Phone: 520-822-6710
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place