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

Primary Purpose

Vulvodynia, Chronic Pelvic Pain

Status
Recruiting
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
Acupuncture
Sponsored by
Medical University of Graz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vulvodynia focused on measuring acupuncture

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)FemaleDoes not accept 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)

Sites / Locations

  • Department of Gynecology/ Medical University of GrazRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Acupuncture Group

Waiting list Group

Arm 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.

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.

Outcomes

Primary Outcome Measures

Change of Subjective Pain Perception
Numeric Rating Scale (NRS) ranging from 0 (no pain) to 10 (worst pain)

Secondary Outcome Measures

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.
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
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
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)
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
Patient treatment satisfaction
"Fragebogen zur Patientenzufriedenheit - ZUF8" is an 8-item tool for measuring global patient satisfaction

Full Information

First Posted
April 4, 2022
Last Updated
June 24, 2022
Sponsor
Medical University of Graz
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1. Study Identification

Unique Protocol Identification Number
NCT05324280
Brief Title
Acupuncture in a Multidisciplinary Approach for Vulvodynia and Chronic Pelvic Pain
Acronym
AMALIA
Official Title
Acupuncture in a Multidisciplinary Approach for Vulvodynia and Chronic Pelvic Pain
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 23, 2022 (Actual)
Primary Completion Date
January 2025 (Anticipated)
Study Completion Date
July 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical University of Graz

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vulvodynia, Chronic Pelvic Pain
Keywords
acupuncture

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomised controlled clinical study with waiting list control group
Masking
None (Open Label)
Allocation
Randomized
Enrollment
68 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Acupuncture Group
Arm Type
Experimental
Arm 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.
Arm Title
Waiting list Group
Arm Type
No Intervention
Arm 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.
Intervention Type
Procedure
Intervention Name(s)
Acupuncture
Intervention Description
Acupuncture treatment will be performed according to a defined protocol, and includes body and ear acupuncture.
Primary Outcome Measure Information:
Title
Change of Subjective Pain Perception
Description
Numeric Rating Scale (NRS) ranging from 0 (no pain) to 10 (worst pain)
Time Frame
evaluation at 3 and 6 months
Secondary Outcome Measure Information:
Title
Change of Health-related quality of life - DSF
Description
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.
Time Frame
evaluation at 3 and 6 months
Title
Change of Health-related quality of life - PHQ-D
Description
Questionnaire Patient Health Questionnaire (PHQ-D) 9 is a sensitive screening tool for detecting depressive symptoms in a general patient population
Time Frame
evaluation at 3 and 6 months
Title
Change of Health-related quality of life - PSQ
Description
Questionnaire Pain sensitivity questionnaire (PSQ) is an instrument for the assessment of pain sensitivity based on pain intensity self ratings of daily life situations
Time Frame
evaluation at 3 and 6 months
Title
Change of Health-related quality of life - EHP-30
Description
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)
Time Frame
evaluation at 3 and 6 months
Title
Change of Subjective improvement
Description
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
Time Frame
evaluation at 3 and 6 months
Title
Patient treatment satisfaction
Description
"Fragebogen zur Patientenzufriedenheit - ZUF8" is an 8-item tool for measuring global patient satisfaction
Time Frame
evaluation at 3 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Facility Information:
Facility Name
Department of Gynecology/ Medical University of Graz
City
Graz
ZIP/Postal Code
8036
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gerda Trutnovsky, MD
Phone
+43 316 385
Ext
81081
Email
gerda.trutnovsky@medunigraz.at
First Name & Middle Initial & Last Name & Degree
Daniela Gold, MD
Phone
+43 316 385
Ext
81437
Email
daniela.gold@medunigraz.at
First Name & Middle Initial & Last Name & Degree
Gerda Trutnovsky, MD
First Name & Middle Initial & Last Name & Degree
Paul Ziller, MD
First Name & Middle Initial & Last Name & Degree
Thomas Ots, MD
First Name & Middle Initial & Last Name & Degree
Daniela Gold, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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Acupuncture in a Multidisciplinary Approach for Vulvodynia and Chronic Pelvic Pain

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