Clinical trial NCT02070029: Acupuncture for Sexual Dysfunction
Official title: Acupuncture in Premenopausal Women With Hypoactive Sexual Desire Disorder: A Prospective Cohort
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypoactive Sexual Desire Disorder (HSDD)
Low Libido
Female Sexual Dysfunction (FSD)
Keywords: Female Sexual Dysfunction (FSD)
Hypoactive Sexual Desire Disorder (HSDD)
Low libido
Acupuncture
Lead sponsor: TriHealth Inc.
Sponsor class: OTHER
Collaborators: name: TriHealth Medical Education Research Fund
First posted: 2014-02-24
Enrollment: 15
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Female Sexual Dysfunction (FSD) affects up to 43% of women in the United States and Hypoactive Sexual Desire Disorder (HSDD) is the most common form. There is no standardized treatment for this condition. We know that alternative therapies such as acupuncture have been beneficial to women suffering from urinary incontinence, chronic lower back pain, and migraines. We hypothesize that the quality of life for premenopausal women with hypoactive sexual desire disorder (HSDD) will improve with initiation of acupuncture therapy for a duration of 5-weeks. Validated questionnaires are administered at the time of enrollment and 1 week after the final acupuncture session as the method of analyzing our primary outcome.

Detailed description: Each woman will receive experimental therapy with acupuncture twice a week for five weeks and complete a packet of validated questionnaires/surveys at the 1st visit in person and at week 6 by mail.

The acupuncture sessions include:

* An Initial Evaluation in which the certified acupuncturist will take a
* History including: chief complaint, diet, level of diaphoresis, water intake, digestive function, menstrual cycling, sleep habits, overall mood
* Physical Exam: inspection of tongue and palpation of pulse
* 25 minutes of resting quietly with acupuncture needles in place
* Needle usage: from8 to 20 needles are typically used, with an average of 14 per session
* Needles are typically placed on the scalp, lower abdomen, elbows and knees

Subsequent Sessions (9 more) with the certified acupuncturist

* 25 minute each, twice weekly, for 5 weeks = total 10 sessions
* Needle usage = 8-20, average 14 per session
* Typically placed on the scalp, lower abdomen, elbows and knees

The questionnaires/surveys include questions about:

* Sexual desire, arousal, lubrication, orgasm, satisfaction and pain
* General physical health
* General emotional and psychological health
* Social relationships

Eligibility criteria: Inclusion Criteria:

* Women aged 18-55 years
* Sexually Active
* Premenopausal
* Documented diagnosis of HSDD as primary cause of FSD (defined as a non adjusted score of ≤ 6 in the desire domain of the FSFI questionnaire)

Exclusion Criteria:

* Postmenopausal, defined as absence of menstruation in the prior 12 months
* Pain or dyspareunia as the primary cause of FSD (defined as a non adjusted score of ≤ 6 in the pain domain of the FSFI)
* History of hysterectomy and/or oophorectomy
* History of chemotherapy, or pelvic irradiation
* Use of hormonal contraception or oral hormone replacement therapy
* Active skin infection or disease
* Blood dyscrasia
* Allergy to acupuncture needles

Primary outcomes:
measure: Female Sexual Function Index (FSFI)
timeFrame: 6 weeks
Secondary outcomes:
measure: Female Sexual Distress Scale (FSDS-R)
timeFrame: 6 weeks
measure: Short Form-12 (SF-12)
timeFrame: 6 weeks
measure: Generalized Anxiety-Disorder-7 (GAD-7) and Prime Health Questionnaire-9 (PHQ-9)
timeFrame: 6 weeks
measure: World Health Organization Quality of Life- BREF (WHOQOL)
timeFrame: 6 weeks
measure: Patient Global Impression of Improvement (PGI-I)
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: TriHealth
state: Ohio
Study officials:
References: