Acupuncture for the Treatment of Vulvodynia | NCT02197429

Studies
Acupuncture for the Treatment of Vulvodynia

NCT02197429

Sponsor

Schlaeger, Judith M., CNM, LAc, PhD

Status

Completed

Last Update Posted

Jul 22, 2014Estimated

Enrollment

36Actual

Phase

Not Applicable

Conditions

Vulvodynia
Vulvar Vestibulitis
Pain
Dyspareunia
Female Sexual Dysfunction Due to Physical Condition

Interventions

Acupuncture

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2012

Primary Completion Date

Dec 2012Actual

Completion Date

Dec 2012Actual

First Submitted Date

Jul 14, 2014

First Submission Date that Met QC Criteria

Jul 18, 2014

First Posted Date

Jul 22, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 18, 2014

Last Update Posted Date

Jul 22, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Hypotheses:

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

36Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Acupuncture	Experimental	Acupuncture	Other: Acupuncture
Wait-list Control	No Intervention	Wait-list Control

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Acupuncture	Other		Acupuncture

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
vulvar pain	Change from baseline in The Short Form McGill Pain Questionnaire at 5 weeks	Baseline and 5 weeks

Secondary Outcomes

Measure	Description	Time Frame
Dyspareunia	Change from baseline in the pain subscale of the Female Sexual Function Index at 5 weeks	Baseline and 5 weeks

Other Outcomes

Measure	Description	Time Frame
Female sexual function	Change from baseline in the total score of the Female Sexual Function Index at 5 weeks	Baseline and 5 weeks

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Judith M. Schlaeger, PhD		Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Glenview Healing Arts		Glenview	Illinois	60025	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
24633161	Background	Stockdale CK, Lawson HW. 2013 Vulvodynia Guideline update. J Low Genit Tract Dis. 2014 Apr;18(2):93-100. doi: 10.1097/LGT.0000000000000021.
19912491	Background	Curran S, Brotto LA, Fisher H, Knudson G, Cohen T. The ACTIV study: acupuncture treatment in provoked vestibulodynia. J Sex Med. 2010 Feb;7(2 Pt 2):981-95. doi: 10.1111/j.1743-6109.2009.01582.x. Epub 2009 Nov 12.

ID	Term
D014845	Vulvar Diseases
D005831	Genital Diseases, Female
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications

ID	Term
D000529	Complementary Therapies
D013812	Therapeutics

ID	Term
D056650	Vulvodynia
D054515	Vulvar Vestibulitis
D010146	Pain
D004414	Dyspareunia