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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 enrollmentJune 23, 2022
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ConditionsVulvodyniaChronic Pelvic Pain

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Vulvodynia
Sponsor
Medical University of Graz
Enrollment
68
Locations
1
Primary Endpoint
Change of Subjective Pain Perception
Status
Recruiting
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar 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)
Registry
clinicaltrials.gov
Start Date
June 23, 2022
End Date
July 2026
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
Medical University of Graz
Responsible Party
Sponsor

Eligibility Criteria

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)

Study Sites (1)

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