Acupuncture in a Multidisciplinary Approach for Vulvodynia and Chronic Pelvic Pain

Study Overview
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Brief Summary
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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)

Official Title
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Acupuncture in a Multidisciplinary Approach for Vulvodynia and Chronic Pelvic Pain

Conditions
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Vulvodynia, Chronic Pelvic Pain

Intervention / Treatment
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* Procedure: Acupuncture


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomised controlled clinical study with waiting list control group
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Acupuncture Group<br>Acupuncture treatment will be performed according to a defined protocol, and includes body and ear acupuncture. The needles will be stimulated manually and will remain for 20 minutes. Body acupuncture needles (diameter 0.3mm, length 30 mm) will be placed on the following positions: On the lower abdomen and back within Th11 and L1 Kidney 13 and 14; alternately unilaterally Ren2 and 3 (midline) On classical acupuncture points on the extremities and the head Stomach 36, Spleen 6; bilaterally Large intestine 4, Liver 3; Bladder 60 bilaterally Du 20 (midline) Ear acupuncture: Ear acupuncture needles (diameter 0,2 mm, length 20mm) will be used: Veg. I (Sympathetic), lower pelvis, hypogastric plexus, Heart,Thalamus, genital system (combining Chinese and French ear acupuncture) For point detection an electric potentiometer will be used. Ear points are punctured according to their generally accepted positions. | Procedure: Acupuncture<br>* Acupuncture treatment will be performed according to a defined protocol, and includes body and ear acupuncture.<br>|
| No Intervention: Waiting list Group<br>Participants allocated to the waiting list control group may continue previously initiated standard therapy, but must not initiate any new treatment. They will be asked not to undergo acupuncture treatment for any condition within the next 3 months. After this period they are offered 10 acupuncture treatments over a period of 3 months. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Subjective Pain Perception | Numeric Rating Scale (NRS) ranging from 0 (no pain) to 10 (worst pain) | evaluation at 3 and 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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 | 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 | 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) | 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 | evaluation at 3 and 6 months | 
| Patient treatment satisfaction | Fragebogen zur Patientenzufriedenheit - ZUF8 is an 8-item tool for measuring global patient satisfaction | evaluation at 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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acupuncture