Acupuncture in a Multidisciplinary Approach for Vulvodynia and Chronic Pelvic Pain (AMALIA)

Medical University of Graz

Status: Enrolling

Conditions: Chronic Pelvic Pain; Vulvodynia

Treatments: Procedure: Acupuncture

Study type: Interventional

Funder types: Other

Identifiers

NCT05324280

Amalia V2.4.

Details and patient eligibility

About

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)

Enrollment: 68 estimated patients

Sex: Female

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

68 participants in 2 patient groups

Acupuncture Group

Experimental group

Description:

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.

Treatment:

Procedure: Acupuncture

Waiting list Group

No Intervention group

Description:

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.