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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
68
Acupuncture treatment will be performed according to a defined protocol, and includes body and ear acupuncture.
Department of Gynecology/ Medical University of Graz
Graz, Austria
RECRUITINGChange of Subjective Pain Perception
Numeric Rating Scale (NRS) ranging from 0 (no pain) to 10 (worst pain)
Time frame: evaluation at 3 and 6 months
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 months
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 months
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 months
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 months
Change of Subjective improvement
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 and 6 months
Patient treatment satisfaction
"Fragebogen zur Patientenzufriedenheit - ZUF8" is an 8-item tool for measuring global patient satisfaction
Time frame: evaluation at 3 months
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