Acupuncture in a Multidisciplinary Approach for Vulvodynia and Chronic Pelvic Pain

Not Applicable

Recruiting

• Conditions: Vulvodynia; Chronic Pelvic Pain
• Interventions: Procedure: Acupuncture

• Registration Number: NCT05324280
• Lead Sponsor: Medical University of Graz

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)

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-04-04
• Study First Submitted QC: 2022-04-04
• Study First Posted: 2022-04-12
• Study Start: 2022-06-23
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-09
• Last Update Posted: 2024-12-12
• Primary Completion: 2026-01
• Study Completion: 2026-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 68

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Acupuncture Group	Acupuncture	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 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
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)
Patient treatment satisfaction	evaluation at 3 months	"Fragebogen zur Patientenzufriedenheit - ZUF8" is an 8-item tool for measuring global patient satisfaction

Trial Locations

Locations (1)

Department of Gynecology/ Medical University of Graz; 🇦🇹 Graz, Austria