Acupuncture in a Multidisciplinary Approach for Vulvodynia and Chronic Pelvic Pain
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-80
SponsorMedical University of Graz
About this trial
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)
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Women with vulvodynia and/or chronic pelvic pain of at least 6 months duration
multidisciplinary treatment for at least 3 months
Disqualifiers
Pregnancy
Current malignancy
Major neurologic or psychiatric morbidity
Study participation in Lydia trial (Lasertherapy for vulvodynia)
Trial design
Design model
Parallel
Treatments tested in this trial
Acupuncture
Procedure/SurgeryAcupuncture treatment will be performed according to a defined protocol, and includes body and ear acupuncture.
Treatment groups
68 Participants
are divided into 2 treatment groupsGroup A: Acupuncture GroupExperimental treatment 1 intervention
Group B: Waiting list GroupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Change of Subjective Pain Perception
Numeric Rating Scale (NRS) ranging from 0 (no pain) to 10 (worst pain)
Time frame
evaluation at 3 and 6 monthsSecondary outcomes
1
Change of Health-related quality of life - DSF
Questionnaire,German Pain Assessment (Deutscher Schmerzfragebogen/DSF). The modules on pain assessment (e.g. pain characteristics, relieving and aggravating factors) and on demographic information will be used.
Time frame
evaluation at 3 and 6 months2
Change of Health-related quality of life - PHQ-D
Questionnaire Patient Health Questionnaire (PHQ-D) 9 is a sensitive screening tool for detecting depressive symptoms in a general patient population
Time frame
evaluation at 3 and 6 months3
Change of Health-related quality of life - PSQ
Questionnaire Pain sensitivity questionnaire (PSQ) is an instrument for the assessment of pain sensitivity based on pain intensity self ratings of daily life situations
Time frame
evaluation at 3 and 6 months4
Change of Health-related quality of life - EHP-30
Questionnaire Endometriosis Health Profile (EHP-30) contains a total of 30 items. The modular part consists of six scales (work, relationship with children, sexual intercourse, infertility, medical profession, and treatment) and contains a total of 23 items. Items within scales are summed to create a raw score, and then each scale is translated into a score ranging from 0 (best health status) to 100 (worst health status)
Time frame
evaluation at 3 and 6 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov