Chronic Pelvic Pain, Vulvodynia
Conditions
Keywords
acupuncture
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)
Interventions
PROCEDUREAcupuncture
Acupuncture treatment will be performed according to a defined protocol, and includes body and ear acupuncture.
Sponsors
Medical University of Graz
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Randomised controlled clinical study with waiting list control group
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 80 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of Subjective Pain Perception | evaluation at 3 and 6 months | Numeric Rating Scale (NRS) ranging from 0 (no pain) to 10 (worst pain) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change of Health-related quality of life - DSF | 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. |
| Change of Health-related quality of life - PHQ-D | 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 |
| Change of Health-related quality of life - PSQ | 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 |
| Change of Health-related quality of life - EHP-30 | 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) |
| Change of Subjective improvement | 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 |
| Patient treatment satisfaction | evaluation at 3 months | "Fragebogen zur Patientenzufriedenheit - ZUF8" is an 8-item tool for measuring global patient satisfaction |
Countries
Austria
Outcome results
None listed