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Completed

NCT Number: NCT05324280

Acupuncture in a Multidisciplinary Approach for Vulvodynia and Chronic Pelvic Pain

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)

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Key information

Conditions

Vulvodynia Chronic Pelvic Pain Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Urogenital Diseases Vulvar Diseases

Age range

18 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Department of Gynecology/ Medical University of Graz

Graz, 8036, Austria

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Acupuncture

Procedure

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

Primary outcomes

  1. Change of Subjective Pain Perception

    Time frame: evaluation at 3 and 6 months

    Numeric Rating Scale (NRS) ranging from 0 (no pain) to 10 (worst pain)

Secondary outcomes

  1. Change of Health-related quality of life - DSF

    Time frame: 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.

  2. Change of Health-related quality of life - PHQ-D

    Time frame: 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

  3. Change of Health-related quality of life - PSQ

    Time frame: 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

  4. Change of Health-related quality of life - EHP-30

    Time frame: 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)

  5. Change of Subjective improvement

    Time frame: 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

  6. Patient treatment satisfaction

    Time frame: evaluation at 3 months

    "Fragebogen zur Patientenzufriedenheit - ZUF8" is an 8-item tool for measuring global patient satisfaction

Sponsors and collaborators

Lead sponsor

Medical University of Graz

Other

Registry information

Acronym: AMALIA

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Apr 12, 2022
Registry last updated
Aug 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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