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CompletedNCT05324280AMALIAUpdated Aug 20, 2026

Acupuncture in a Multidisciplinary Approach for Vulvodynia and Chronic Pelvic Pain

An interventional study of Acupuncture in Vulvodynia and Chronic Pelvic Pain, sponsored by Medical University of Graz. Completed at 1 site in Austria. Open to female participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-08-20.

Sponsored by Medical University of Graz · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
45
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
Female
01

Study 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)
02

Conditions studied

  • Vulvodynia
  • Chronic Pelvic Pain

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Keywords

  • acupuncture
03

In context

Vulvodynia

106 studies on the registry are indexed under Vulvodynia; 21 are open to participants now.

This study's enrollment of 45 is close to the median of 44 across 79 interventional studies indexed under Vulvodynia.

Browse Vulvodynia studies →

Lead sponsor

Medical University of Graz is the lead sponsor of 459 studies on the registry; 98 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
Female
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Pregnancy
  • Current malignancy
  • Major neurologic or psychiatric morbidity
  • Study participation in Lydia trial (Lasertherapy for vulvodynia)
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
45 participants (actual)

Study arms

  • Experimental
    Acupuncture Group

    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

  • No intervention
    Waiting list Group

    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.

Interventions

  • ProcedureAcupuncture

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

06

What researchers measure

Primary outcomes

  1. Change of Subjective Pain Perception

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

    Time frame: evaluation at 3 and 6 months

Secondary outcomes

  1. 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.

    Time frame: evaluation at 3 and 6 months

  2. 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

    Time frame: evaluation at 3 and 6 months

  3. 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

    Time frame: evaluation at 3 and 6 months

  4. 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)

    Time frame: evaluation at 3 and 6 months

  5. 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

    Time frame: evaluation at 3 and 6 months

  6. Patient treatment satisfaction

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

    Time frame: evaluation at 3 months

07

Study locations

1 site
  • Department of Gynecology/ Medical University of Graz
    Graz, 8036, Austria
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 20, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05324280
Lead sponsor
Medical University of Graz
Responsible party
Sponsor
First posted
Apr 12, 2022
Start date
Jun 23, 2022
Primary completion
Jan 30, 2026
Completion
Jul 30, 2026
Last update
Aug 20, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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