Acupuncture for Vulvodynia: A Pre-pilot Study

NCT ID: NCT02704234

Last Updated: 2024-02-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-23
• Study Completion Date: 2022-11-07

Brief Summary

Vulvodynia is a women's pain condition. Women have pain in their vulva, the area in their genitals between the vagina and labia (lips of the vagina). They also have pain when they have sexual intercourse or insert anything in the vagina. Sometimes they have so much pain, that they cannot have sex.

This research is being done for two reasons. The first reason is to test a set of special needles called double-blinded acupuncture needles to give acupuncture treatments (one is a real needle and the other is a fake needle). The second reason is to develop a protocol (checklist) that will be used in this and future studies, and to identify and resolve any procedural problems. The protocol will be first tested by the principal investigator who is also an acupuncturist. The investigator will perform acupuncture using the protocol, if necessary change the protocol, and then teach a second acupuncturist using the modified protocol how to use the double-blinded acupuncture needles.

The real needle called the penetrating needle penetrates the skin. The fake needle called the non-penetrating placebo touch needle does not penetrate the skin but it touches the skin so it feels like a needle is being inserted. It has a blunt tip.

Participants can't see which needle they are getting acupuncture with because the needles are housed in a double-blinded needle device which has two tubes (an inner and an outer) that neither the acupuncturists nor the participants can see through.

If a fake acupuncture needle can be used in acupuncture research like a sugar pill is used for drug studies to see how well the real medicine works, the investigators can see how effective acupuncture is. The investigators will be testing these needles to treat participants with vulvodynia.

Conditions

Vulvodynia; Vulvar Vestibulitis; Dyspareunia; Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: QUADRUPLE

Study Groups

Active Acupuncture

Active Acupuncture 2 times per week for 5 weeks

Group Type: EXPERIMENTAL

Active Acupuncture

Intervention Type: OTHER

Active Acupuncture two times per week for 5 weeks

Placebo

Placebo Acupuncture 2 times per week for 5 weeks

Group Type: PLACEBO_COMPARATOR

Placebo Acupuncture

Intervention Type: OTHER

Placebo Acupuncture two times per week for 5 weeks

Interventions

Active Acupuncture

Active Acupuncture two times per week for 5 weeks

Intervention Type: OTHER

Placebo Acupuncture

Placebo Acupuncture two times per week for 5 weeks

Intervention Type: OTHER

Other Intervention Names

Penetrating Acupuncture Needle

Eligibility Criteria

Inclusion Criteria

• women previously diagnosed with generalized vulvodynia
• women previously diagnosed with localized vestibulodynia,

Exclusion Criteria

• pregnancy
• menopause
• interstitial cystitis
• irritable bowel syndrome
• untreated vaginitis
• cervicitis
• pelvic inflammatory disease
• any other pelvic pathology causing pain
• concomitant physical therapy
• concomitant biofeedback
• concomitant massage
• additional acupuncture

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Illinois at Chicago

OTHER

Sponsor Role: lead

Responsible Party

Judith Schlaeger

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

judith schlaeger, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Illinois at Chicago

Locations

A Center for Oriental Medicine

Wilmette, Illinois, United States

Countries

United States

References

Schlaeger JM, Takakura N, Yajima H, Takayama M, Steffen AD, Gabzdyl EM, Nisi RA, McGowan Gruber K, Bussell JM, Wilkie DJ. Double-blind acupuncture needles: a multi-needle, multi-session randomized feasibility study. Pilot Feasibility Stud. 2018 Apr 13;4:72. doi: 10.1186/s40814-018-0265-9. eCollection 2018.

Reference Type: DERIVED

PMID: 29686883 (View on PubMed)

Other Identifiers

2015-0692

Identifier Type: -

Identifier Source: org_study_id