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Effect of Acupuncture on Patient Vulvodynia Outcomes

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ClinicalTrials.gov Identifier: NCT03364127
Recruitment Status : Recruiting
First Posted : December 6, 2017
Last Update Posted : April 17, 2019
Sponsor:
Collaborator:
University of Florida
Information provided by (Responsible Party):
University of Illinois at Chicago

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

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 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 : April 15, 2018
Estimated Primary Completion Date : September 2022
Estimated Study Completion Date : September 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acupuncture

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




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.



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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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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03364127


Contacts
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Contact: Marie Suarez, PhD (312) 413-5449 msuarez@uic.edu
Contact: Judith M Schlaeger, PhD 3124134669 jschlaeg@uic.edu

Locations
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United States, Illinois
University of Illinois at Chicago College of Nursing Recruiting
Chicago, Illinois, United States, 60612
Contact: Marie Suarez, PhD    312-413-5449    msuarez@uic.edu   
Contact: Judith Schlaeger    7083341097 ext schlaeger    judithschlaeger@gmail.com   
Principal Investigator: Judith M Schlaeger, PhD         
Sponsors and Collaborators
University of Illinois at Chicago
University of Florida
Investigators
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Principal Investigator: Judith M. Schlaeger, PhD University of Illinois at Chicago

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Responsible Party: University of Illinois at Chicago
ClinicalTrials.gov Identifier: NCT03364127     History of Changes
Other Study ID Numbers: 2017-0885
First Posted: December 6, 2017    Key Record Dates
Last Update Posted: April 17, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Illinois at Chicago:
Vulvar Pain, Dyspareunia
Additional relevant MeSH terms:
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Vulvodynia
Vulvar Vestibulitis
Vulvar Diseases
Genital Diseases, Female
Vulvitis