VulvodyniaAMALIANCT05324280
Acupuncture in a Multidisciplinary Approach for Vulvodynia and Chronic Pelvic Pain
A study testing Acupuncture in people with Vulvodynia and Chronic Pelvic Pain, run by Medical University of Graz at 1 site in Austria.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Vulvodynia, Chronic Pelvic Pain
- What is being tested?
- Acupuncture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteAustria
- Study dates
- 23 Jun 2022to 30 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women with vulvodynia and/or chronic pelvic pain of at least 6 months duration
- multidisciplinary treatment for at least 3 months
Who cannot join
- Pregnancy
- Current malignancy
- Major neurologic or psychiatric morbidity
- Study participation in Lydia trial (Lasertherapy for vulvodynia)
Trial locations and contacts
1 site in 1 country.
About this study
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)
- Conditions
- Vulvodynia, Chronic Pelvic Pain
- Being tested
- Acupuncture
- Keywords
- acupuncture
- Medical subject headings
- Vulvodynia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureProcedure or surgery
Acupuncture treatment will be performed according to a defined protocol, and includes body and ear acupuncture.
| Study group | Role | What they receive |
|---|---|---|
| Acupuncture Group | Experimental | 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. Receives: Procedure: Acupuncture |
| Waiting list Group | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Subjective Pain Perception
Numeric Rating Scale (NRS) ranging from 0 (no pain) to 10 (worst pain)
Measured: evaluation at 3 and 6 months
Secondary outcomes (6)
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.
Measured: evaluation at 3 and 6 months
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
Measured: evaluation at 3 and 6 months
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
Measured: evaluation at 3 and 6 months
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)
Measured: evaluation at 3 and 6 months
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
Measured: evaluation at 3 and 6 months
Patient treatment satisfaction
"Fragebogen zur Patientenzufriedenheit - ZUF8" is an 8-item tool for measuring global patient satisfaction
Measured: evaluation at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2022
- Study start23 Jun 2022
- Primary completion30 Jan 2026
- Study completion30 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VulvodyniaStudies of the same condition, open and under way.
- More trials run by Medical University of GrazThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised controlled clinical study with waiting list control group
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05324280
- Sponsor's protocol ID
- Amalia V2.4.
- Acronym
- AMALIA
- Status last verified
- Aug 2026
- First submitted
- 4 Apr 2022
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acupuncture in a Multidisciplinary Approach for Vulvodynia and Chronic Pelvic Pain
- ClinicalTrials.gov ID
- NCT05324280
- Acronym / sponsor ID
- AMALIA / Amalia V2.4.
- Conditions
- Vulvodynia, Chronic Pelvic Pain
- Keywords
- acupuncture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Study start
- 23 Jun 2022 (actual)
- Primary completion
- 30 Jan 2026 (actual)
- Study completion
- 30 Jul 2026 (actual)
- First posted
- 12 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomised controlled clinical study with waiting list control group
| Arm | Type | Receives |
|---|---|---|
| Acupuncture Group | Experimental | Procedure: AcupunctureAcupuncture 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. |
| Waiting list Group | No intervention | –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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Women with vulvodynia and/or chronic pelvic pain of at least 6 months duration
- multidisciplinary treatment for at least 3 months
Key exclusion criteria (4 listed)
- Pregnancy
- Current malignancy
- Major neurologic or psychiatric morbidity
- Study participation in Lydia trial (Lasertherapy for vulvodynia)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AcupunctureAcupuncture treatment will be performed according to a defined protocol, and includes body and ear acupuncture. | Procedure or surgery | Acupuncture Group |
Primary outcome
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)
6 secondary outcomes
Change of Health-related quality of life - DSF
Time frame: evaluation at 3 and 6 months
Change of Health-related quality of life - PHQ-D
Time frame: evaluation at 3 and 6 months
Change of Health-related quality of life - PSQ
Time frame: evaluation at 3 and 6 months
Change of Health-related quality of life - EHP-30
Time frame: evaluation at 3 and 6 months
Change of Subjective improvement
Time frame: evaluation at 3 and 6 months
Patient treatment satisfaction
Time frame: evaluation at 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture in people with Vulvodynia and Chronic Pelvic Pain, run by Medical University of Graz at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Subjective Pain Perception (time frame: evaluation at 3 and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2026.