Actively Recruiting
Acupuncture in a Multidisciplinary Approach for Vulvodynia and Chronic Pelvic Pain
Led by Medical University of Graz · Updated on 2024-12-12
68
Participants Needed
1
Research Sites
25 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness of acupuncture as part of a combined treatment approach for women experiencing vulvodynia and chronic pelvic pain (CPP), which are common and difficult gynecologic pain conditions. This randomized controlled clinical study aims to compare acupuncture with a waiting list control group to better understand its impact on pain and quality of life. Participants will be randomly assigned to either receive acupuncture treatment or be placed on a waiting list. The acupuncture involves a defined protocol of body and ear acupuncture, using needles stimulated manually and left in place for 20 minutes. Body acupuncture targets specific points on the lower abdomen, back, extremities, and head, while ear acupuncture includes points related to the sympathetic system and genital area. Those in the waiting list group may continue their current standard therapy but cannot start new treatments or acupuncture during the first three months. After this period, they are offered a course of acupuncture treatments over three months. During the study, participants will be assessed at 3 and 6 months for changes in subjective pain perception and health-related quality of life using various questionnaires. Additional measures include subjective improvement and treatment satisfaction evaluated at 3 months. The study monitors outcomes related to pain and quality of life, with total participation lasting at least 6 months. Safety and patient well-being are maintained throughout the trial period.
CONDITIONS
Brief Title
Acupuncture in a Multidisciplinary Approach for Vulvodynia and Chronic Pelvic Pain
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women with vulvodynia and/or chronic pelvic pain lasting at least 6 months
- Received multidisciplinary treatment for at least 3 months
- Aged between 18 and 80 years
You will not qualify if you...
- Pregnancy
- Current malignancy
- Major neurological or psychiatric illness
- Participation in the Lydia trial (Lasertherapy for vulvodynia)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 3 months
Participants receive acupuncture treatment according to a defined protocol, including body and ear acupuncture with manual needle stimulation for 20 minutes per session.
10 acupuncture treatment visits over 3 months
Duration - 3 months
Participants are evaluated for changes in pain perception, quality of life, subjective improvement, and treatment satisfaction after treatment completion.
Visits for evaluations at 3 and 6 months
Trial Site Locations
Total: 1 location
1
Department of Gynecology/ Medical University of Graz
Graz, Austria, 8036
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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