Effect of Acupuncture on Patient Vulvodynia Outcomes

• ClinicalTrials.gov Identifier: NCT03364127
• Recruitment Status: Completed
• First Posted: December 6, 2017
• Last Update Posted: January 30, 2023
• Sponsor: University of Illinois at Chicago
• Collaborator: University of Florida
• Information provided by (Responsible Party): Judith Schlaeger, University of Illinois at Chicago

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Vulvodynia; Vulvodynia, Generalized; Vulvar Vestibulitis	Other: Active Acupuncture; Other: Placebo Acupuncture	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 90 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Double-blind Phase 2 RCT: Effect of Acupuncture on Patient Vulvodynia Outcomes
• Actual Study Start Date: February 23, 2018
• Actual Primary Completion Date: October 26, 2022
• Actual Study Completion Date: November 7, 2022

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Experimental: Active Acupuncture; Active Acupuncture two times per week for 5 weeks	Other: Active Acupuncture; Active Acupuncture two times per week for 5 weeks; Other Name: Penetrating Acupuncture Needle
Placebo Comparator: Placebo Acupuncture; Placebo Acupuncture two times per week for 5 weeks	Other: Placebo Acupuncture; Placebo Acupuncture two times per week for 5 weeks; Other Name: Skin-touch Placebo Needle

Outcome Measures

Primary Outcome Measures :

1. Average Pain Intensity will be measured with the Pain Intensity Numbers Scale (PINS). [ Time Frame: baseline and after the 10th acupuncture treatment week 5 ]
   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.

Secondary Outcome Measures :

1. Dyspareunia Subscale 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.
2. 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.
3. 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. ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 45 Years (Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

1. a previous diagnosis of generalized vulvodynia or provoked vestibulodynia
2. 18 to 45 years old
3. a pain now score 4 or higher with tampon insertion and removal performed at the initial screening exam
4. speak and read English

Exclusionary Criteria:

1. infectious conditions of the vulva/vagina
2. inflammatory conditions of the vulva/vagina
3. neoplastic disorders of the vulva/vagina
4. neurologic disorders of the vulva/vagina
5. trauma to the genitals
6. iatrogenic conditions of the genitals
7. hormonal deficiencies
8. co-morbid pelvic pain conditions (to avoid confounding pain outcomes) such as pelvic inflammatory disease and documented history of endometriosis
9. 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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Contacts and Locations

Locations

United States, Illinois

University of Illinois at Chicago College of Nursing

Chicago, Illinois, United States, 60612

Sponsors and Collaborators

University of Illinois at Chicago

University of Florida

Investigators

• Principal Investigator: Judith M. Schlaeger, PhD; University of Illinois at Chicago

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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. 2023 Jan;29(1):50-54. doi: 10.1089/jicm.2022.0647. Epub 2022 Sep 21.

• Responsible Party: Judith Schlaeger, Associate Professor, University of Illinois at Chicago
• ClinicalTrials.gov Identifier: NCT03364127
• Other Study ID Numbers: 2017-0885
• First Posted: December 6, 2017
• Last Update Posted: January 30, 2023
• Last Verified: January 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Judith Schlaeger, University of Illinois at Chicago:

Vulvar Pain, Dyspareunia

Additional relevant MeSH terms:

Vulvodynia; Vulvar Vestibulitis; Vulvar Diseases; Vulvitis