Back to resultsAcupuncture for the Treatment of Vulvodynia
Primary Purpose
Vulvodynia, Vulvar Vestibulitis, Pain
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Acupuncture
Sponsored by
About this trial
This is an interventional treatment trial for Vulvodynia focused on measuring Vulvodynia, Acupuncture, Provoked Vestibulodynia, Vulvar Vestibulitis, Vulvar Pain, Dyspareunia, Female Sexual Function
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.
Sites / Locations
- Glenview Healing Arts
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Acupuncture
Wait-list Control
Arm Description
Acupuncture
Wait-list Control
Outcomes
Primary Outcome Measures
vulvar pain
Change from baseline in The Short Form McGill Pain Questionnaire at 5 weeks
Secondary Outcome Measures
Dyspareunia
Change from baseline in the pain subscale of the Female Sexual Function Index at 5 weeks
Full Information
NCT ID
NCT02197429
First Posted
July 14, 2014
Last Updated
July 18, 2014
Sponsor
Schlaeger, Judith M., CNM, LAc, PhD
1. Study Identification
Unique Protocol Identification Number
NCT02197429
Brief Title
Acupuncture for the Treatment of Vulvodynia
Official Title
Acupuncture for the Treatment of Vulvodynia
Study Type
Interventional
2. Study Status
Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
February 2012 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Schlaeger, Judith M., CNM, LAc, PhD
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vulvodynia, Vulvar Vestibulitis, Pain, Dyspareunia, Female Sexual Dysfunction Due to Physical Condition
Keywords
Vulvodynia, Acupuncture, Provoked Vestibulodynia, Vulvar Vestibulitis, Vulvar Pain, Dyspareunia, Female Sexual Function
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Acupuncture
Arm Type
Experimental
Arm Description
Acupuncture
Arm Title
Wait-list Control
Arm Type
No Intervention
Arm Description
Wait-list Control
Intervention Type
Other
Intervention Name(s)
Acupuncture
Primary Outcome Measure Information:
Title
vulvar pain
Description
Change from baseline in The Short Form McGill Pain Questionnaire at 5 weeks
Time Frame
Baseline and 5 weeks
Secondary Outcome Measure Information:
Title
Dyspareunia
Description
Change from baseline in the pain subscale of the Female Sexual Function Index at 5 weeks
Time Frame
Baseline and 5 weeks
Other Pre-specified Outcome Measures:
Title
Female sexual function
Description
Change from baseline in the total score of the Female Sexual Function Index at 5 weeks
Time Frame
Baseline and 5 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Judith M. Schlaeger, PhD
Official's Role
Principal Investigator
Facility Information:
Facility Name
Glenview Healing Arts
City
Glenview
State/Province
Illinois
ZIP/Postal Code
60025
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
24633161
Citation
Stockdale CK, Lawson HW. 2013 Vulvodynia Guideline update. J Low Genit Tract Dis. 2014 Apr;18(2):93-100. doi: 10.1097/LGT.0000000000000021.
Results Reference
background
PubMed Identifier
19912491
Citation
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.
Results Reference
background
PubMed Identifier
11328221
Citation
Danielsson I, Sjoberg I, Ostman C. Acupuncture for the treatment of vulvar vestibulitis: a pilot study. Acta Obstet Gynecol Scand. 2001 May;80(5):437-41.
Results Reference
background
PubMed Identifier
22965186
Citation
Vickers AJ, Cronin AM, Maschino AC, Lewith G, MacPherson H, Foster NE, Sherman KJ, Witt CM, Linde K; Acupuncture Trialists' Collaboration. Acupuncture for chronic pain: individual patient data meta-analysis. Arch Intern Med. 2012 Oct 22;172(19):1444-53. doi: 10.1001/archinternmed.2012.3654.
Results Reference
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Learn more about this trial
Acupuncture for the Treatment of Vulvodynia
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