Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05324280
Other study ID # Amalia V2.4.
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date June 23, 2022
Est. completion date July 2025

Study information

Verified date June 2022
Source Medical University of Graz
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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)


Recruitment information / eligibility

Status Recruiting
Enrollment 68
Est. completion date July 2025
Est. primary completion date January 2025
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 80 Years
Eligibility 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)

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Austria Department of Gynecology/ Medical University of Graz Graz

Sponsors (1)

Lead Sponsor Collaborator
Medical University of Graz

Country where clinical trial is conducted

Austria, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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. evaluation at 3 and 6 months
Secondary 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 evaluation at 3 and 6 months
Secondary 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 evaluation at 3 and 6 months
Secondary 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) evaluation at 3 and 6 months
Secondary 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 evaluation at 3 and 6 months
Secondary Patient treatment satisfaction "Fragebogen zur Patientenzufriedenheit - ZUF8" is an 8-item tool for measuring global patient satisfaction evaluation at 3 months
See also
  Status Clinical Trial Phase
Completed NCT05478746 - Effects of Flourish HEC on Localized Provoked Vulvodynia N/A
Completed NCT02404961 - Women's Health Study: Immunological Factors and Risk of Vulvodynia
Completed NCT00751010 - Relationship: Interstitial Cystitis & Vulvodynia-Part 2 N/A
Completed NCT00607490 - A Randomized Clinical Trial for Women With Vulvodynia N/A
Recruiting NCT03640624 - Multidisciplinary Treatment of Chronic Vulvar Pain N/A
Recruiting NCT05343182 - Vestibulectomy Surgical Techniques Comparison Study N/A
Recruiting NCT05518630 - An Investigation of Nomothetic Versus Idiographic Assessment in Chronic Pain
Recruiting NCT05597358 - Efficacy of High Intensity Laser for Provoked Vestibulodynia N/A
Completed NCT01304589 - Savella in Treatment for Provoked Vestibulodynia Phase 3
Completed NCT00590590 - Safety and Efficacy of Two Vaginal Products Versus Placebo in Patients With Vaginal Discomfort Phase 2
Recruiting NCT06138171 - Personality, Defences, Central Sensitization, and Trauma in Women With Chronic Migraine, Fibromyalgia, and Vulvodynia
Completed NCT01996384 - Provoked, Localized Vulvodynia Treatment With Acupuncture and Lidocaine Pilot Study Phase 1
Completed NCT01664962 - Search for Genetic Basis of Vulvodynia N/A
Recruiting NCT05955313 - Effectiveness of Low-dose Naltrexone in Patients With Different Types of Vulvodynia Phase 2
Completed NCT02773641 - Placebo-controlled RCT of Botulinum Toxin A as a Treatment for Provoked Vestibulodynia Phase 3
Completed NCT00501774 - A Search for Helicobacter Pylori in Localized Vulvodynia N/A
Completed NCT04057755 - Botulinum Toxin A as a Treatment for Provoked Vestibulodynia Phase 3
Terminated NCT04016467 - Effect of Spinal Manipulation on Vulvar Pain N/A
Completed NCT01935063 - Study to Compare the Efficacy of Cognitive-behavioral Couple Therapy and Lidocaine for Provoked Vestibulodynia N/A
Completed NCT02809612 - An Internet-based Information Platform for Vulvodynia Patients N/A