Skip to main content
MedPathMedPath Home
Clinical Trials/NCT05324280
NCT05324280
Recruiting
Not Applicable

Acupuncture in a Multidisciplinary Approach for Vulvodynia and Chronic Pelvic Pain

Medical University of Graz1 site in 1 country68 target enrollmentStarted: June 23, 2022Last updated:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
ConditionsVulvodyniaChronic Pelvic Pain

Overview

Phase
Not Applicable
Status
Recruiting
Sponsor
Medical University of Graz
Enrollment
68
Locations
1
Primary Endpoint
Change of Subjective Pain Perception
OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

Brief Summary

Background: Vulvodynia and chronic pelvic pain (CPP) are common and challenging gynecologic pain syndromes. A multidisciplinary approach is recommended.

Study aim: To study the effectiveness of acupuncture as part of a multimodal treatment for women with vulvodynia and CPP.

Design: Randomised controlled clinical study

Study Population: Recruitment from a University outpatient clinic Study groups: Participants will be randomised (1:1)

  • Acupuncture group
  • Waiting list control group

Sample size: 68 patients

Study outcome

  • Subjective Pain Perception (VAS)
  • Health-related quality of life (questionnaires)

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 80 Years (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Women with vulvodynia and/or chronic pelvic pain of at least 6 months duration
  • •multidisciplinary treatment for at least 3 months

Exclusion Criteria

  • •Pregnancy
  • •Current malignancy
  • •Major neurologic or psychiatric morbidity
  • •Study participation in Lydia trial (Lasertherapy for vulvodynia)

Outcomes

Primary Outcomes

Change of Subjective Pain Perception

Time Frame: evaluation at 3 and 6 months

Numeric Rating Scale (NRS) ranging from 0 (no pain) to 10 (worst pain)

Secondary Outcomes

  • Change of Health-related quality of life - DSF(evaluation at 3 and 6 months)
  • Change of Health-related quality of life - PHQ-D(evaluation at 3 and 6 months)
  • Change of Subjective improvement(evaluation at 3 and 6 months)
  • Change of Health-related quality of life - PSQ(evaluation at 3 and 6 months)
  • Change of Health-related quality of life - EHP-30(evaluation at 3 and 6 months)
  • Patient treatment satisfaction(evaluation at 3 months)

Investigators

Sponsor
Medical University of Graz
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

Loading locations...

Similar Trials

Completed
Not Applicable
Acupuncture for Vulvodynia: A Pre-pilot StudyVulvodyniaVulvar VestibulitisDyspareuniaPain
NCT02704234University of Illinois at Chicago6
Active, not recruiting
Not Applicable
Multidisciplinary Treatment of Chronic Vulvar PainVulvodyniaChronic Pain
NCT03640624Norwegian University of Science and Technology106
Unknown
Not Applicable
Acupuncture for Female With Non-cyclic Chronic Pelvic PainChronic Pelvic Pain
NCT04553562Guang'anmen Hospital of China Academy of Chinese Medical Sciences150
Unknown
Not Applicable
Effect of Two Acupuncture Protocols on VulvodyniaVulvodyniaVulvodynia, GeneralizedVulvar VestibulitisVulvar Pain
NCT03481621McLean Center for Complementary and Alternative Medicine, PLC51
Completed
Not Applicable
Effect of Acupuncture on Patient Vulvodynia OutcomesVulvodyniaVulvodynia, GeneralizedVulvar Vestibulitis
NCT03364127University of Illinois at Chicago89