NCT Number: NCT05324280
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)
Interested in participating?
Request Info18 year–80 year
Female
Interventional
Not applicable
Graz, 8036, Austria
Location status: Recruiting
Daniela Gold, MD
CONTACT
+43 316 385 ext. 81437
Daniela Gold, MD
SUB_INVESTIGATOR
Gerda Trutnovsky, MD
CONTACT
+43 316 385 ext. 81081
Gerda Trutnovsky, MD
PRINCIPAL_INVESTIGATOR
Paul Ziller, MD
SUB_INVESTIGATOR
Thomas Ots, MD
SUB_INVESTIGATOR
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Acupuncture treatment will be performed according to a defined protocol, and includes body and ear acupuncture.
Time frame: evaluation at 3 and 6 months
Numeric Rating Scale (NRS) ranging from 0 (no pain) to 10 (worst pain)
Time frame: evaluation at 3 and 6 months
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 months
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 months
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 months
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 months
Patient Global Impression of Improvement (PGI-I) scale is a ), a single item instrument with a 7-step Likert type response scale to assess subjective improvement after treatment
Time frame: evaluation at 3 months
"Fragebogen zur Patientenzufriedenheit - ZUF8" is an 8-item tool for measuring global patient satisfaction
Medical University of Graz
Other
Acronym: AMALIA
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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