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Acupuncture for Sexual Dysfunction

Primary Purpose

Hypoactive Sexual Desire Disorder (HSDD), Low Libido, Female Sexual Dysfunction (FSD)

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Acupuncture
Sponsored by
TriHealth Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypoactive Sexual Desire Disorder (HSDD) focused on measuring Female Sexual Dysfunction (FSD), Hypoactive Sexual Desire Disorder (HSDD), Low libido, Acupuncture

Eligibility Criteria

18 Years - 55 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • TriHealth

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Acupuncture

Arm Description

Acupuncture Therapy - twice weekly sessions for 5 weeks: 1st session 60 minutes with remaining 9 session approximately 45 minutes each. Physical exam at 1st session includes evaluation of peripheral pulses, head, neck, throat/tongue. No pelvic exam required.

Outcomes

Primary Outcome Measures

Female Sexual Function Index (FSFI)
Determined by a change in the desire domain of the Female Sexual Function Index (FSFI) from baseline at enrollment to study completion at 6 weeks after initiation of intervention.

Secondary Outcome Measures

Female Sexual Distress Scale (FSDS-R)
Determined by functional data points distributed at enrollment and 6 weeks: Female Sexual Distress scale - revised (FSDS-R)
Short Form-12 (SF-12)
Determined by functional data points distributed at enrollment and 6 weeks: Short Form-12 (SF-12)
Generalized Anxiety-Disorder-7 (GAD-7) and Prime Health Questionnaire-9 (PHQ-9)
Determined by functional data points distributed at enrollment and 6 weeks: Generalized Anxiety-Disorder-7 (GAD-7) and Prime Health Questionnaire-9 (PHQ-9)
World Health Organization Quality of Life- BREF (WHOQOL)
Determined by functional data points distributed at enrollment and 6 weeks: World Health Organization Quality of Life- BREF (WHOQOL)
Patient Global Impression of Improvement (PGI-I)
Determined by functional data points distributed at enrollment and 6 weeks: Patient Global Impression of Improvement (PGI-I)

Full Information

First Posted
January 26, 2014
Last Updated
October 15, 2014
Sponsor
TriHealth Inc.
Collaborators
TriHealth Medical Education Research Fund
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1. Study Identification

Unique Protocol Identification Number
NCT02070029
Brief Title
Acupuncture for Sexual Dysfunction
Official Title
Acupuncture in Premenopausal Women With Hypoactive Sexual Desire Disorder: A Prospective Cohort
Study Type
Interventional

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
TriHealth Inc.
Collaborators
TriHealth Medical Education Research Fund

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypoactive Sexual Desire Disorder (HSDD), Low Libido, Female Sexual Dysfunction (FSD)
Keywords
Female Sexual Dysfunction (FSD), Hypoactive Sexual Desire Disorder (HSDD), Low libido, Acupuncture

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Acupuncture
Arm Type
Experimental
Arm Description
Acupuncture Therapy - twice weekly sessions for 5 weeks: 1st session 60 minutes with remaining 9 session approximately 45 minutes each. Physical exam at 1st session includes evaluation of peripheral pulses, head, neck, throat/tongue. No pelvic exam required.
Intervention Type
Procedure
Intervention Name(s)
Acupuncture
Intervention Description
Acupuncture Therapy - Initial Evaluation 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 central and peripheral pulses. Chinese Diagnoses for Female Sexual Dysfunction: Kidney Yang Deficiency; Liver Qi Stagnation; Generalized Blood Deficiency; Spleen Yang Deficiency; Heart Fire - Subsequent Sessions 25 minute sessions, 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
Primary Outcome Measure Information:
Title
Female Sexual Function Index (FSFI)
Description
Determined by a change in the desire domain of the Female Sexual Function Index (FSFI) from baseline at enrollment to study completion at 6 weeks after initiation of intervention.
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Female Sexual Distress Scale (FSDS-R)
Description
Determined by functional data points distributed at enrollment and 6 weeks: Female Sexual Distress scale - revised (FSDS-R)
Time Frame
6 weeks
Title
Short Form-12 (SF-12)
Description
Determined by functional data points distributed at enrollment and 6 weeks: Short Form-12 (SF-12)
Time Frame
6 weeks
Title
Generalized Anxiety-Disorder-7 (GAD-7) and Prime Health Questionnaire-9 (PHQ-9)
Description
Determined by functional data points distributed at enrollment and 6 weeks: Generalized Anxiety-Disorder-7 (GAD-7) and Prime Health Questionnaire-9 (PHQ-9)
Time Frame
6 weeks
Title
World Health Organization Quality of Life- BREF (WHOQOL)
Description
Determined by functional data points distributed at enrollment and 6 weeks: World Health Organization Quality of Life- BREF (WHOQOL)
Time Frame
6 weeks
Title
Patient Global Impression of Improvement (PGI-I)
Description
Determined by functional data points distributed at enrollment and 6 weeks: Patient Global Impression of Improvement (PGI-I)
Time Frame
6 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
TriHealth
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45220
Country
United States

12. IPD Sharing Statement

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Acupuncture for Sexual Dysfunction

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