Acupuncture in a Multidisciplinary Approach for Vulvodynia and Chronic Pelvic Pain

Vulvodynia Clinical Trial

— AMALIA  

Official title:

Acupuncture in a Multidisciplinary Approach for Vulvodynia and Chronic Pelvic Pain

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05324280
• Other study ID #: Amalia V2.4.
• Status: Recruiting
• Phase: N/A
• Start date: June 23, 2022
• Est. completion date: July 2025

Study information

• Verified date: June 2022
• Source: Medical University of Graz
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 68
• Est. completion date: July 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Chronic Pelvic Pain
• Pelvic Pain
• Vulvodynia

Intervention

Procedure:
• Acupuncture
Acupuncture treatment will be performed according to a defined protocol, and includes body and ear acupuncture.

Locations

Country	Name	City	State
Austria	Department of Gynecology/ Medical University of Graz	Graz

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Graz

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Patient treatment satisfaction	"Fragebogen zur Patientenzufriedenheit - ZUF8" is an 8-item tool for measuring global patient satisfaction	evaluation at 3 months