Acupuncture in a Multidisciplinary Approach for Vulvodynia and Chronic Pelvic Pain

NCT05324280 | Recruiting

• 1 other identifier: Amalia V2.4.
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief 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)

Conditions

Vulvodynia; Chronic Pelvic Pain

Keywords

acupuncture

Outcome Measures

Primary Outcomes (1)

• Change of Subjective Pain Perception

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

  evaluation at 3 and 6 months

Secondary Outcomes (6)

• Change of Health-related quality of life - DSF

  evaluation at 3 and 6 months

• Change of Health-related quality of life - PHQ-D

  evaluation at 3 and 6 months

• Change of Health-related quality of life - PSQ

  evaluation at 3 and 6 months

• Change of Health-related quality of life - EHP-30

  evaluation at 3 and 6 months

• Change of Subjective improvement

  evaluation at 3 and 6 months

Study Arms (2)

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.

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.

Interventions

Acupuncture PROCEDURE

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

Acupuncture Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women with vulvodynia and/or chronic pelvic pain of at least 6 months duration
• multidisciplinary treatment for at least 3 months

You may not qualify if:

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

Sponsors & Collaborators

• Medical University of Graz: lead

Study Sites (1)

Department of Gynecology/ Medical University of Graz

Graz, 8036, Austria

RECRUITING

MeSH Terms

Conditions

Vulvodynia

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Vulvar Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomised controlled clinical study with waiting list control group

Study Record Dates

• First Submitted: April 4, 2022
• First Posted: April 12, 2022
• Study Start: June 23, 2022
• Primary Completion: January 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: December 12, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)