Effect of Acupuncture on Patient Vulvodynia Outcomes

NCT03364127 | Completed Results DMC

• 1 other identifier: 2017-0885
• Study Type: interventional
• Target: 89
• Locations: 1 country
• Sites: 1

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.

Conditions

Vulvodynia; Vulvodynia, Generalized; Vulvar Vestibulitis

Keywords

Vulvar Pain, Dyspareunia

Outcome Measures

Primary Outcomes (1)

• Average Pain Intensity Will be Measured With the Pain Intensity Numbers Scale (PINS).

  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 and after the 10th acupuncture treatment week 5

Secondary Outcomes (3)

• Dyspareunia Subscale of the Female Sexual Function Index (FSFI)

  baseline and after the 10th acupuncture treatment week 5

• Total Score of the Female Sexual Function Index (FSFI)

  baseline and after the 10th acupuncture treatment week 5

• Vulvar Pain Intensity Will be Measured With the Pain Intensity Numbers Scale (PINS).

  after the 10th acupuncture treatment weekly up to 12 weeks post last acupuncture treatment.

Study Arms (2)

Experimental: Active Acupuncture

ACTIVE COMPARATOR

Active Acupuncture two times per week for 5 weeks

Other: Active Acupuncture

Placebo Acupuncture

PLACEBO COMPARATOR

Placebo Acupuncture two times per week for 5 weeks

Other: Placebo Acupuncture

Interventions

Active Acupuncture OTHER

Active Acupuncture two times per week for 5 weeks

Also known as: Penetrating Acupuncture Needle

Experimental: Active Acupuncture

Placebo Acupuncture OTHER

Placebo Acupuncture two times per week for 5 weeks

Also known as: Skin-touch Placebo Needle

Placebo Acupuncture

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• a previous diagnosis of generalized vulvodynia or provoked vestibulodynia
• 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
• 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.

Sponsors & Collaborators

• University of Illinois at Chicago: lead
• University of Florida: collaborator

Study Sites (1)

University of Illinois at Chicago College of Nursing

Chicago, Illinois, 60612, United States

Location

Related Publications (2)

• 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.

  PMID: 36387991 DERIVED

• 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.

  PMID: 36130137 DERIVED

MeSH Terms

Conditions

Vulvodynia; Vulvar Vestibulitis; Dyspareunia

Condition Hierarchy (Ancestors)

Vulvar Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Vulvitis; Genital Diseases, Male; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Limitations and Caveats

No limitations or caveats.

Results Point of Contact

• Title: Judith M. Schlaeger, PhD, CNM, LAc, FAAN
• Organization: University of Illinois Chicago

jschlaeg@uic.edu

(312) 413-4469

Study Officials

• Judith M. Schlaeger, PhD

  University of Illinois at Chicago

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 30, 2017
• First Posted: December 6, 2017
• Study Start: February 23, 2018
• Primary Completion: October 26, 2022
• Study Completion: November 7, 2022
• Last Updated: May 30, 2025
• Results First Posted: May 30, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: The data will be available immediately upon release of this ClinicalTrials.gov website for 5 years.
• Access Criteria: Please email the Principal Investigator: Judith Schlaeger, jschlaeg@uic.edu

Locations

US (1)