Adults 18 to 45, female only, with Vulvodynia or Vulvodynia, Generalized. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Average Pain Intensity Will be Measured With the Pain Intensity Numbers Scale (PINS).Primary· baseline and after the 10th acupuncture treatment week 5
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.
Baseline
Group
Value
95% CI
Experimental: Active Acupuncture
3.90
± 2.39
Placebo Acupuncture
3.51
± 2.31
After the 10th acupuncture treatment week 5
Group
Value
95% CI
Experimental: Active Acupuncture
2.48
± 2.11
Placebo Acupuncture
2.22
± 2.09
Dyspareunia Subscale of the Female Sexual Function Index (FSFI)Secondary· baseline and after the 10th acupuncture treatment week 5
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.
Baseline
Group
Value
95% CI
Experimental: Active Acupuncture
1.22
± 0.89
Placebo Acupuncture
1.38
± 1.16
after the 10th acupuncture treatment week 5
Group
Value
95% CI
Experimental: Active Acupuncture
1.61
± 1.76
Placebo Acupuncture
1.83
± 1.82
Total Score of the Female Sexual Function Index (FSFI)Secondary· baseline and after the 10th acupuncture treatment week 5
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
Baseline
Group
Value
95% CI
Experimental: Active Acupuncture
15.9
± 7.05
Placebo Acupuncture
17.4
± 5.92
After the 10th acupuncture treatment week 5
Group
Value
95% CI
Experimental: Active Acupuncture
17.0
± 8.29
Placebo Acupuncture
19.3
± 7.71
Vulvar Pain Intensity Will be Measured With the Pain Intensity Numbers Scale (PINS).Secondary· after the 10th acupuncture treatment weekly up to 12 weeks post last 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.
Week 1
Group
Value
95% CI
Experimental: Active Acupuncture/Duration of Effect
4.19
± 2.33
Placebo Acupuncture/Duration of Effect
2.60
± 2.09
Week 2
Group
Value
95% CI
Experimental: Active Acupuncture/Duration of Effect
3.37
± 2.50
Placebo Acupuncture/Duration of Effect
3.68
± 2.31
Week 3
Group
Value
95% CI
Experimental: Active Acupuncture/Duration of Effect
3.79
± 2.68
Placebo Acupuncture/Duration of Effect
3.16
± 1.98
Week 4
Group
Value
95% CI
Experimental: Active Acupuncture/Duration of Effect
3.23
± 2.09
Placebo Acupuncture/Duration of Effect
3.23
± 2.39
Week 5
Group
Value
95% CI
Experimental: Active Acupuncture/Duration of Effect
4.55
± 2.54
Placebo Acupuncture/Duration of Effect
3.13
± 1.63
Week 6
Group
Value
95% CI
Experimental: Active Acupuncture/Duration of Effect
3.88
± 2.68
Placebo Acupuncture/Duration of Effect
3.33
± 1.78
Week 7
Group
Value
95% CI
Experimental: Active Acupuncture/Duration of Effect
3.22
± 1.99
Placebo Acupuncture/Duration of Effect
3.84
± 2.48
Week 8
Group
Value
95% CI
Experimental: Active Acupuncture/Duration of Effect
2.67
± 1.80
Placebo Acupuncture/Duration of Effect
2.79
± 1.57
Sponsor's own description
This study evaluates acupuncture for the treatment of vulvodynia; specifically if it reduces vulvar pain and pain with intercourse. It also examines how long the effect of acupuncture lasts in women with vulvodynia. Half of the women will receive acupuncture and the other half will receive placebo acupuncture. Women who get a reduction in pain will monitor there pain once a week for up to 12 weeks to see how long the acupuncture effect lasts.
Publications & conference data
5 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07391241 — A Phase 2 Study to Evaluate the Efficacy and Safety of Pudafensine in Vulvodynia (Provoked Vestibulodynia)
· Phase 2
· recruiting
NCT07092332 — Young Vulvodynia: Effect and Efficacy of Multimodal Treatment.
· NA
· recruiting
NCT06865963 — Vestibulodynia At High Resolution: Omics Approach to Improve Diagnosis
· recruiting
NCT05955313 — Effectiveness of Low-dose Naltrexone in Patients With Different Types of Vulvodynia
· Phase 2
· recruiting
Other University of Illinois at Chicago trials
Trials by the same sponsor.
NCT07498322 — Chicago Data-driven Opioid Use Disorder Screening, Engagement, Treatment and Planning System
· NA
· not yet recruiting
NCT07387705 — On Track for Wellness (OTW) Stepped Wedge Cluster Randomized Trial
· Phase 1
· not yet recruiting
NCT07504120 — The Effect of Remotely Delivered Pilates on Physical , and Psychological Outcomes in Individuals With Multiple Sclerosis
· NA
· not yet recruiting
NCT07160582 — Cognitive-Motor Training for AD/ADRD Prevention
· NA
· not yet recruiting
NCT07498348 — Apple Watch Evaluation of Endodontics Occupational Stress
· not yet recruiting
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University of Illinois at Chicago
Last refreshed: 30 May 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03364127.