- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03364127
Effect of Acupuncture on Patient Vulvodynia Outcomes
Double-blind Phase 2 RCT: Effect of Acupuncture on Patient Vulvodynia Outcomes
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The investigators' goal is to demonstrate the effects of acupuncture for the treatment of vulvodynia. Up to 14 million American women have vulvodynia, a debilitating pain syndrome characterized by pain (burning, irritation, stinging or rawness) in the vulva and dyspareunia that renders sexual intercourse virtually impossible and leaves these women desperate for relief. Not only are women in pain, but they often lose their partners or have relationship difficulties due to their inability to have sexual intercourse. No therapies have been proven efficacious and rapid pain relief is unpredictable and rarely possible. After exhausting Western Medicine options, these women often turn to acupuncture. But in contrast to other pain conditions, there have been no acupuncture sham control studies of vulvodynia.
Only four studies, including one of the investigators', provide some evidence of the effect of acupuncture on vulvodynia. In three, single-group acupuncture studies, women had less pain, better quality of life, improved sexual health, and improved mental health. The investigators' randomized wait-list controlled pilot study of 36 women with vulvodynia showed great promise. The investigators found a statistically significant and clinically meaningful reduction in vulvar pain and dyspareunia, and an increase in overall sexual function after a 5-week, 13-needle, 10 session acupuncture protocol. This newly developed, standardized acupuncture treatment protocol is the first breakthrough in the treatment of this puzzling disorder. It includes acupuncture points that relieve pain in the genitals. The results of the investigators' initial pilot study provided the first evidence from a two-group design that the acupuncture protocol could reduce pain intensity, pain during intercourse, and increase overall sexual function. These findings, however, warrant stronger evidence to support the inference that the effect is indeed due to the acupuncture since ours or no other study included a sham control or provided follow-up data beyond immediate posttest, which means that the duration of the acupuncture effect is unknown. The investigators' recent feasibility study paves the way to overcome this gap by use of double-blind acupuncture needles. Findings from these two studies support the investigators' proposal for the world's first double-blind randomized controlled trial (RCT) of acupuncture for vulvodynia while exploring its duration of effect.
The investigators propose a phase 2 double-blind, pretest/posttest RCT to compare effects of penetrating needles or the skin touch placebo needles on vulvar pain in our 13-needle, 10-session acupuncture treatment protocol. A sample of 130 women, with a diagnosis of vulvodynia, either generalized or provoked vestibulodynia, 18 to 45 years of age will be recruited from clinical and community settings and 80 subjects are expected to complete the study. Stratified by type of vulvodynia, participants will be randomized 1:1 either to the penetrating needle group or the skin touch placebo needle group. These double-blind needles will provide a strong sham procedure to mask both the acupuncturist and subject to the type of needle used for the 10-treatment protocol.
Specific aims are to:
Aim 1. Compare the penetrating needle group and the skin touch placebo needle group for effects on the: (a) primary outcome: vulvar pain (PAINReportIt® average pain intensity, 0-10), and (b) secondary outcomes: dyspareunia (FSFI dyspareunia) and sexual function (FSFI total). The investigators hypothesize that controlling for baseline values, at posttest there will be statistically significant less vulvar pain (primary) and dyspareunia and better sexual function in the penetrating needle group compared to the skin touch placebo group.
Aim 2. In participants with a clinically meaningful reduction in pain intensity (at least 1.5 points) at posttest compared to pretest, describe the duration of the acupuncture treatment and placebo effects weekly until pain returns to pretest or up to 12 weeks after posttest. The investigators will describe the variability over time in vulvar pain intensity (0-10) after a tampon insertion-removal stimulus and thereby explore the duration of the effect by intervention group, vulvodynia subgroups, and demographic subgroups (e.g., age, race, occupation). These findings will provide insights to guide future research on initial and maintenance acupuncture for vulvodynia.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Marie Suarez, PhD
- Phone Number: (312) 413-5449
- Email: msuarez@uic.edu
Study Contact Backup
- Name: Judith M Schlaeger, PhD
- Phone Number: 3124134669
- Email: jschlaeg@uic.edu
Study Locations
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Illinois
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Chicago, Illinois, United States, 60612
- University of Illinois at Chicago College of Nursing
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- a previous diagnosis of generalized vulvodynia or provoked vestibulodynia
- 18 to 45 years old
- a pain now score 4 or higher with tampon insertion and removal performed at the initial screening exam
- speak and read English
Exclusionary Criteria:
- infectious conditions of the vulva/vagina
- inflammatory conditions of the vulva/vagina
- neoplastic disorders of the vulva/vagina
- neurologic disorders of the vulva/vagina
- trauma to the genitals
- iatrogenic conditions of the genitals
- hormonal deficiencies
- co-morbid pelvic pain conditions (to avoid confounding pain outcomes) such as pelvic inflammatory disease and documented history of endometriosis
- menopause
Patients may have a history of but not have active in the last 6 months migraine headaches, temporomandibular joint disease (TMJ), irritable bowel syndrome (IBS), interstitial cystitis, painful bladder syndrome, or fibromyalgia.
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Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Experimental: Active Acupuncture
Active Acupuncture two times per week for 5 weeks
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Active Acupuncture two times per week for 5 weeks
Other Names:
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Placebo Comparator: Placebo Acupuncture
Placebo Acupuncture two times per week for 5 weeks
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Placebo Acupuncture two times per week for 5 weeks
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Average Pain Intensity will be measured with the Pain Intensity Numbers Scale (PINS).
Time Frame: baseline and after the 10th acupuncture treatment week 5
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The subject calls the pain intensity a number between 0 and 10, where 0 is "no pain" and 10 is "pain as bad as it could be."
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.
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baseline and after the 10th acupuncture treatment week 5
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Dyspareunia Subscale of the Female Sexual Function Index (FSFI)
Time Frame: baseline and after the 10th acupuncture treatment week 5
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The FSFI is a 19-item, multi-dimensional, self-report measure that examines six areas of sexual response: desire, arousal, lubrication, orgasm, satisfaction, and dyspareunia.
In addition to the six subscale scores, there is a total combined score (FSFIt) that is a measure of overall sexual function.
Possible scores range from zero to five for each item and higher scores indicate improved function.
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baseline and after the 10th acupuncture treatment week 5
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Total score of the Female Sexual Function Index (FSFI)
Time Frame: baseline and after the 10th acupuncture treatment week 5
|
The FSFI is a 19-item, multi-dimensional, self-report measure that examines six areas of sexual response: desire, arousal, lubrication, orgasm, satisfaction, and dyspareunia.
In addition to the six subscale scores, there is a total combined score (FSFIt) that is a measure of overall sexual function.
Possible scores range from zero to five for each item and higher scores indicate improved function.
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baseline and after the 10th acupuncture treatment week 5
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Average Pain Intensity will be measured with the Pain Intensity Numbers Scale (PINS).
Time Frame: after the 10th acupuncture treatment weekly up to 12 weeks post last acupuncture treatment.
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The subject calls the pain intensity a number between 0 and 10, where 0 is "no pain" and 10 is "pain as bad as it could be."
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.
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after the 10th acupuncture treatment weekly up to 12 weeks post last acupuncture treatment.
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Judith M. Schlaeger, PhD, University of Illinois at Chicago
Publications and helpful links
General Publications
- Schlaeger JM, Suarez ML, Glayzer JE, Kobak WH, Meinel M, Steffen AD, Burke LA, Pauls HA, Yao Y, Takayama M, Yajima H, Kaptchuk TJ, Takakura N, Foster D, Wilkie DJ. Protocol for double-blind RCT of acupuncture for vulvodynia. Contemp Clin Trials Commun. 2022 Nov 2;30:101029. doi: 10.1016/j.conctc.2022.101029. eCollection 2022 Dec.
- Desloge AA, Patil CL, Glayzer JE, Suarez ML, Kobak WH, Meinel M, Steffen AD, Burke LA, Yao Y, Takayama M, Yajima H, Kaptchuk TJ, Takakura N, Foster DC, Wilkie DJ, Schlaeger JM. Women's Experience of Living with Vulvodynia Pain: Why They Participated in a Randomized Controlled Trial of Acupuncture. J Integr Complement Med. 2022 Sep 21. doi: 10.1089/jicm.2022.0647. Online ahead of print.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2017-0885
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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