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Completed

NCT Number: NCT02197429

Acupuncture for the Treatment of Vulvodynia

A randomized controlled pilot study was conducted to evaluate the effect of an acupuncture protocol for the treatment of vulvodynia.

Hypotheses:

1. Acupuncture reduces vulvar pain and dyspareunia in women with vulvodynia. 2. Acupuncture increases sexual function in women with vulvodynia.

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Key information

Conditions

Vulvodynia Dyspareunia Female Sexual Dysfunction Due to Physical Condition Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Diseases, Male Male Urogenital Diseases Mental Disorders Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Sexual Dysfunction, Physiological Sexual Dysfunctions, Psychological Signs and Symptoms Urogenital Diseases Vulvar Diseases Vulvar Vestibulitis Vulvitis

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Glenview Healing Arts

Glenview, Illinois, 60025, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Previously diagnosed with either generalized vulvodynia, localized vestibulodynia, or both
  • Provoked vulvodynia
  • Unprovoked vulvodynia
  • Women between 18 years of age and menopause

Exclusion criteria

  • Pregnancy
  • Menopause
  • Interstitial cystitis
  • Irritable bowel syndrome
  • Untreated vaginitis
  • Cervicitis
  • Pelvic inflammatory disease
  • Diagnosed with other pelvic pathology causing pain
  • Concomitantly receiving physical therapy
  • Concomitantly receiving biofeedback,
  • Concomitantly receiving massage
  • Concomitantly receiving additional acupuncture.

Treatment and study plan

Acupuncture

Other

Primary outcomes

  1. vulvar pain

    Time frame: Baseline and 5 weeks

    Change from baseline in The Short Form McGill Pain Questionnaire at 5 weeks

Secondary outcomes

  1. Dyspareunia

    Time frame: Baseline and 5 weeks

    Change from baseline in the pain subscale of the Female Sexual Function Index at 5 weeks

Other outcomes

  1. Female sexual function

    Time frame: Baseline and 5 weeks

    Change from baseline in the total score of the Female Sexual Function Index at 5 weeks

Sponsors and collaborators

Lead sponsor

Schlaeger, Judith M., CNM, LAc, PhD

Indiv

Registry information

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Jul 22, 2014
Registry last updated
Jul 22, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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