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

M

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.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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