Trial Outcomes & Findings for Effect of Acupuncture on Patient Vulvodynia Outcomes (NCT NCT03364127)
NCT ID: NCT03364127
Last Updated: 2025-05-30
Results Overview
The subject calls the pain intensity a number ranging between the minimum value, 0 and 10, the maximum value. Zero represents "no pain" and 10 represents"pain as bad as it could be". Higher scores mean more pain. The PINS will include three items (pain now, least and worst pain in the past 24 hours), which are used to calculate the average of pain intensity. The PINS with the three items and standardized instructions is part of PAINReportIt® which is an electronic version of the 1970 version of the McGill Pain Questionnaire.
COMPLETED
NA
89 participants
baseline and after the 10th acupuncture treatment week 5
2025-05-30
Participant Flow
Four-hundred and fifty women were assessed for eligibility of which 290 did not meet eligibility criteria and 71 declined to participate. Eighty-nine participants were enrolled between February 2018 and September 2022. Participants were recruited from community settings as well as from medical clinics throughout the Chicagoland area, from healthcare provider referrals, and from the National Vulvodynia Association website.
No participants were excluded after randomization and assignment to the groups.
Participant milestones
| Measure |
Experimental: Active Acupuncture
Active Acupuncture two times per week for 5 weeks
Active Acupuncture: Active Acupuncture two times per week for 5 weeks
|
Placebo Acupuncture
Placebo Acupuncture two times per week for 5 weeks
Placebo Acupuncture: Placebo Acupuncture two times per week for 5 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
45
|
44
|
|
Overall Study
COMPLETED
|
39
|
42
|
|
Overall Study
NOT COMPLETED
|
6
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effect of Acupuncture on Patient Vulvodynia Outcomes
Baseline characteristics by cohort
| Measure |
Experimental: Active Acupuncture
n=45 Participants
Active Acupuncture two times per week for 5 weeks
Active Acupuncture: Active Acupuncture two times per week for 5 weeks
|
Placebo Acupuncture
n=44 Participants
Placebo Acupuncture two times per week for 5 weeks
Placebo Acupuncture: Placebo Acupuncture two times per week for 5 weeks
|
Total
n=89 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
29.0 years
STANDARD_DEVIATION 8.25 • n=5 Participants
|
31.4 years
STANDARD_DEVIATION 8.35 • n=7 Participants
|
30.2 years
STANDARD_DEVIATION 8.34 • n=5 Participants
|
|
Sex: Female, Male
Female
|
45 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
89 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
10 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
34 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
69 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
31 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
45 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
89 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: baseline and after the 10th acupuncture treatment week 5Population: Participants receiving active acupuncture and placebo acupuncture
The subject calls the pain intensity a number ranging between the minimum value, 0 and 10, the maximum value. Zero represents "no pain" and 10 represents"pain as bad as it could be". Higher scores mean more pain. The PINS will include three items (pain now, least and worst pain in the past 24 hours), which are used to calculate the average of pain intensity. The PINS with the three items and standardized instructions is part of PAINReportIt® which is an electronic version of the 1970 version of the McGill Pain Questionnaire.
Outcome measures
| Measure |
Experimental: Active Acupuncture
n=45 Participants
Active Acupuncture two times per week for 5 weeks
Active Acupuncture: Active Acupuncture two times per week for 5 weeks
|
Placebo Acupuncture
n=44 Participants
Placebo Acupuncture two times per week for 5 weeks
Placebo Acupuncture: Placebo Acupuncture two times per week for 5 weeks
|
|---|---|---|
|
Average Pain Intensity Will be Measured With the Pain Intensity Numbers Scale (PINS).
Baseline
|
3.90 score on a scale
Standard Deviation 2.39
|
3.51 score on a scale
Standard Deviation 2.31
|
|
Average Pain Intensity Will be Measured With the Pain Intensity Numbers Scale (PINS).
After the 10th acupuncture treatment week 5
|
2.48 score on a scale
Standard Deviation 2.11
|
2.22 score on a scale
Standard Deviation 2.09
|
SECONDARY outcome
Timeframe: baseline and after the 10th acupuncture treatment week 5Population: Participants receiving active acupuncture and placebo acupuncture.
The Dyspareunia Subscale of the FSFI measures pain with sexual intercourse. The FSFI consists of three items scored using a scale ranging from zero to five. The scores of the three items are then summed and multiplied by a factor of 0.4, resulting in a minimum score of 0 and a maximum score of 6.0, with higher scores indicating less pain with sexual intercourse.
Outcome measures
| Measure |
Experimental: Active Acupuncture
n=45 Participants
Active Acupuncture two times per week for 5 weeks
Active Acupuncture: Active Acupuncture two times per week for 5 weeks
|
Placebo Acupuncture
n=44 Participants
Placebo Acupuncture two times per week for 5 weeks
Placebo Acupuncture: Placebo Acupuncture two times per week for 5 weeks
|
|---|---|---|
|
Dyspareunia Subscale of the Female Sexual Function Index (FSFI)
Baseline
|
1.22 score on a scale
Standard Deviation 0.89
|
1.38 score on a scale
Standard Deviation 1.16
|
|
Dyspareunia Subscale of the Female Sexual Function Index (FSFI)
after the 10th acupuncture treatment week 5
|
1.61 score on a scale
Standard Deviation 1.76
|
1.83 score on a scale
Standard Deviation 1.82
|
SECONDARY outcome
Timeframe: baseline and after the 10th acupuncture treatment week 5Population: Participants receiving active acupuncture and placebo acupuncture.
The FSFI is a 19-item, multi-dimensional, self-report measure that measures overall sexual function from six domains of sexual response: desire, arousal, lubrication, orgasm, satisfaction, and dyspareunia. The six subscale scores are measured on a scale of 0-5 for each item. Individual item responses from each of the 6 domains are added together to achieve a domain score and are each multipled by a factor (desire, 0.6; arousal, 0.3; lubrication, 0.3; orgasm, 0.4; satisfaction, 0.4; and dyspareunia, 0.4). These final domain scores are summed to obtain the Total Score of the FSFI, ranging from 2.0 to 36.0, with higher scores indicating better overall sexual function.
Outcome measures
| Measure |
Experimental: Active Acupuncture
n=45 Participants
Active Acupuncture two times per week for 5 weeks
Active Acupuncture: Active Acupuncture two times per week for 5 weeks
|
Placebo Acupuncture
n=44 Participants
Placebo Acupuncture two times per week for 5 weeks
Placebo Acupuncture: Placebo Acupuncture two times per week for 5 weeks
|
|---|---|---|
|
Total Score of the Female Sexual Function Index (FSFI)
Baseline
|
15.9 score on a scale
Standard Deviation 7.05
|
17.4 score on a scale
Standard Deviation 5.92
|
|
Total Score of the Female Sexual Function Index (FSFI)
After the 10th acupuncture treatment week 5
|
17.0 score on a scale
Standard Deviation 8.29
|
19.3 score on a scale
Standard Deviation 7.71
|
SECONDARY outcome
Timeframe: after the 10th acupuncture treatment weekly up to 12 weeks post last acupuncture treatment.Population: Participants receiving active acupuncture and placebo acupuncture that entered the Duration of Effect phase. Participants with a clinically meaningful reduction in pain intensity (at least 1.5 points) at the 10th acupuncture treatment compared to pretest, will measure Vulvar Pain Intensity weekly until pain returns to pretest or up to 12 weeks after the 10th acupuncture treatment.
The subject calls the pain intensity a number between 0, the minimum value and 10, the maximum value. Zero is "no pain" and 10 is "pain as bad as it could be." Higher scores indicate a worse outcome. The PINS will include one item (vulvar pain intensity). The PINS with vulvar pain intensity and standardized instructions is part of PAINReportIt® which is an electronic version of the 1970 version of the McGill Pain Questionnaire.
Outcome measures
| Measure |
Experimental: Active Acupuncture
n=24 Participants
Active Acupuncture two times per week for 5 weeks
Active Acupuncture: Active Acupuncture two times per week for 5 weeks
|
Placebo Acupuncture
n=24 Participants
Placebo Acupuncture two times per week for 5 weeks
Placebo Acupuncture: Placebo Acupuncture two times per week for 5 weeks
|
|---|---|---|
|
Vulvar Pain Intensity Will be Measured With the Pain Intensity Numbers Scale (PINS).
Week 1
|
4.19 score on a scale
Standard Deviation 2.33
|
2.60 score on a scale
Standard Deviation 2.09
|
|
Vulvar Pain Intensity Will be Measured With the Pain Intensity Numbers Scale (PINS).
Week 2
|
3.37 score on a scale
Standard Deviation 2.50
|
3.68 score on a scale
Standard Deviation 2.31
|
|
Vulvar Pain Intensity Will be Measured With the Pain Intensity Numbers Scale (PINS).
Week 3
|
3.79 score on a scale
Standard Deviation 2.68
|
3.16 score on a scale
Standard Deviation 1.98
|
|
Vulvar Pain Intensity Will be Measured With the Pain Intensity Numbers Scale (PINS).
Week 4
|
3.23 score on a scale
Standard Deviation 2.09
|
3.23 score on a scale
Standard Deviation 2.39
|
|
Vulvar Pain Intensity Will be Measured With the Pain Intensity Numbers Scale (PINS).
Week 5
|
4.55 score on a scale
Standard Deviation 2.54
|
3.13 score on a scale
Standard Deviation 1.63
|
|
Vulvar Pain Intensity Will be Measured With the Pain Intensity Numbers Scale (PINS).
Week 6
|
3.88 score on a scale
Standard Deviation 2.68
|
3.33 score on a scale
Standard Deviation 1.78
|
|
Vulvar Pain Intensity Will be Measured With the Pain Intensity Numbers Scale (PINS).
Week 7
|
3.22 score on a scale
Standard Deviation 1.99
|
3.84 score on a scale
Standard Deviation 2.48
|
|
Vulvar Pain Intensity Will be Measured With the Pain Intensity Numbers Scale (PINS).
Week 8
|
2.67 score on a scale
Standard Deviation 1.80
|
2.79 score on a scale
Standard Deviation 1.57
|
|
Vulvar Pain Intensity Will be Measured With the Pain Intensity Numbers Scale (PINS).
Week 9
|
4.00 score on a scale
Standard Deviation 2.83
|
2.32 score on a scale
Standard Deviation 0.99
|
|
Vulvar Pain Intensity Will be Measured With the Pain Intensity Numbers Scale (PINS).
Week 10
|
3.50 score on a scale
Standard Deviation 1.78
|
2.77 score on a scale
Standard Deviation 1.59
|
|
Vulvar Pain Intensity Will be Measured With the Pain Intensity Numbers Scale (PINS).
Week 11
|
2.89 score on a scale
Standard Deviation 2.57
|
3.04 score on a scale
Standard Deviation 1.39
|
|
Vulvar Pain Intensity Will be Measured With the Pain Intensity Numbers Scale (PINS).
Week 12
|
5.40 score on a scale
Standard Deviation 2.19
|
2.64 score on a scale
Standard Deviation 1.22
|
Adverse Events
Experimental: Active Acupuncture
Placebo Acupuncture
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Judith M. Schlaeger, PhD, CNM, LAc, FAAN
University of Illinois Chicago
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place