Acupuncture in a Multidisciplinary Approach for Vulvodynia and Chronic Pelvic Pain

Not Applicable

Recruiting

• Conditions: Vulvodynia; Chronic Pelvic Pain

• 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

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