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

Sponsor

Medical University of Graz (Other)

Overall Status

Recruiting

CT.gov ID

NCT05324280

Collaborator

(none)

Enrollment

Location

Arms

36.3

Anticipated Duration (Months)

1.9

Patients Per Site Per Month

Study Details

Study Description

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)

Condition or Disease	Intervention/Treatment	Phase
Vulvodynia Chronic Pelvic Pain	Procedure: Acupuncture	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

68 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Randomised controlled clinical study with waiting list control groupRandomised controlled clinical study with waiting list control group

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Acupuncture in a Multidisciplinary Approach for Vulvodynia and Chronic Pelvic Pain

Actual Study Start Date :

Jun 23, 2022

Anticipated Primary Completion Date :

Jan 1, 2025

Anticipated Study Completion Date :

Jul 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
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 Acupuncture treatment will be performed according to a defined protocol, and includes body and ear 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.

Arm

Intervention/Treatment

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

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

Outcome Measures

Primary Outcome Measures

Change of Subjective Pain Perception [evaluation at 3 and 6 months]
Numeric Rating Scale (NRS) ranging from 0 (no pain) to 10 (worst pain)

Secondary Outcome Measures

Change of Health-related quality of life - DSF [evaluation at 3 and 6 months]
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.
Change of Health-related quality of life - PHQ-D [evaluation at 3 and 6 months]
Questionnaire Patient Health Questionnaire (PHQ-D) 9 is a sensitive screening tool for detecting depressive symptoms in a general patient population
Change of Health-related quality of life - PSQ [evaluation at 3 and 6 months]
Questionnaire Pain sensitivity questionnaire (PSQ) is an instrument for the assessment of pain sensitivity based on pain intensity self ratings of daily life situations
Change of Health-related quality of life - EHP-30 [evaluation at 3 and 6 months]
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)
Change of Subjective improvement [evaluation at 3 and 6 months]
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
Patient treatment satisfaction [evaluation at 3 months]
"Fragebogen zur Patientenzufriedenheit - ZUF8" is an 8-item tool for measuring global patient satisfaction

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

Female

Accepts 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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Gynecology/ Medical University of Graz	Graz		Austria	8036

Sponsors and Collaborators

Medical University of Graz

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Medical University of Graz

ClinicalTrials.gov Identifier:

NCT05324280

Other Study ID Numbers:

Amalia V2.4.

First Posted:

Apr 12, 2022

Last Update Posted:

Jun 30, 2022

Last Verified:

Jun 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Medical University of Graz

acupuncture

Additional relevant MeSH terms:

Vulvodynia

Pelvic Pain

Study Results

No Results Posted as of Jun 30, 2022