- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03481621
Effect of Two Acupuncture Protocols on Vulvodynia (Acu/Vul-pain)
Pilot Clinical Trial of Two Acupuncture Protocols on Vulvodynia
Vulvodynia is a common condition in women (16%); however, at this time there is no known effective non-pharmacological therapy reported. Acupuncture is one complementary and alternative medicine therapy used by many patients with vulvodynia; some case reports show that acupuncture may be an effective intervention. In recent years, there were some studies registered took at like at actual trials of acupuncture on vulvodynia, but either they did not reach the trial aims, some studies did not get enough patients or the trial designs mimic drug studies and did not reflect acupuncture real characteristics.
This study evaluates acupuncture for the treatment of vulvodynia; specifically, if it reduces vulvar pain, pain duration and pain with intercourse. It also examines how long the effect of acupuncture lasts in women with vulvodynia. One third of the women will receive acupuncture focused on pudendal nerve distribution area; another one third of the women will receive acupuncture focused on traditional meridian points; the other one third of women will use standard care (without acupuncture). Women who get a reduction in pain (included in subjective and objective scores) will have their pain monitored once a week for up to 6 weeks to see if the acupuncture effect lasts.
Study Overview
Status
Intervention / Treatment
Detailed Description
Aims of this study:
- Get preliminary data for future larger, randomized- controlled trials.
- See whether acupuncture is better than no-acupuncture treatments (where participations are following standard care for this condition), or at least have probable better outcomes than no acupuncture treatment (there may not be significance in statistics, given the small sample in current proposed trial);
- See if acupuncture group 1a (with focus on the points in pudendal nerve distribution near the pain area) has better results(at least, a trend) than acupuncture group 1b (traditional acupuncture focus on meridian or distal points).
The basic design and interventions:
- Diagnosis: Vulvodynia/Vulval pain by gynecologist or pain specialist/doctor, who will adopt International diagnose criteria.
- Patient sample (estimated): 17 in each acupuncture group (34 total), and 17 patients in the no-acupuncture group or standard care waiting list . Total 51 patients;
Groups:
Group 1a (17 cases): acupuncture, using the local points in pudendal nerve distribution area (tender points, and up to two other set of acupuncture points); Group 1b (17 cases): traditional acupuncture, using common meridian or distal points; Group 2 (17 cases): standard care, waiting list. This group will receive no acupuncture treatment.
- Randomized method: If the patient feels comfortable with acupuncture, they will be randomly assigned to either Group 1a or Group1b using randomization numbers generated by computer; if the patients still are under the treatments of routine conventional treatments, such as using pain medications, local injections, and physical therapies, or other non-surgical procedure, they will serve as participants in the standard care group, the waiting list.
- Blind Method: Patients will be blind as to the purpose of the study as well as to the groups that they are assigned too. Each participant in either group 1a or 1b will receive actual, real acupuncture treatment but, depending on their group assignment, the strategy and points used will vary.
Treatments:
Group 1a: acupuncture: needling focus on Hui yang, pudendal nerve points and local point(s) near the pain location with needling manipulation (such as twisting 200/min for 2-5 minutes at pudendal nerve points); Group 1b: acupuncture: using meridian points, focus on Xue Hai (SP9), San Yin Jiao (SP6), Zu San Li (ST36); Both groups also use: Shen Ting (GV24), Tou Wei (ST 8), Yin Tang (EX2) for helping to release stress and create calm.
Both group 1(a/b) and group 2 patients are all allowed to use pain medications (in which the medications' name and how many pills used during 6 weeks' observation period will be carefully document); the standard care group actually is a waiting list, without acupuncture intervention. Follow up: 6 weeks.
Acupuncture time and frequency: 45 min per session, once or twice per week, for 6-12 sessions (in 6 weeks).
- Main observation:
(1) Objective pain score(tested using cotton swab); (2) Patient self reported pain score (subjective, before Cotton swab test); Others: Pain duration and pain score during intercourse.
8. Statistics: student t-test.
Sample calculation: The expected difference (ECSD) between two means is 3, and the common within group standard deviation is 3. Giving an 80 chance that an 0.05 level test of significance will find a statistically significant difference between two sample means are compared, the sample size is approximately 17 per group.
Comparisons:
- At the end point (end of 6 weeks), make comparisons between acupuncture (1a+1b) group and group 2, acupuncture 1a and group 2, acupuncture 1b and group 2; between acupuncture 1a and acupuncture 1b; respectively.
- At the end point (end of 6 weeks), make comparisons in each group self (before and after).
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Arthur Y Fan, MD(CHN),PhD
- Phone Number: 7034994428
- Email: ArthurFan@ChineseMedicineDoctor.us
Study Contact Backup
- Name: Sarah F Alemi, DAc,LAc
- Phone Number: 7035478197
- Email: ArthurFan@ChineseMedicineDoctor.us
Study Locations
-
-
Virginia
-
Vienna, Virginia, United States, 22182
- Recruiting
- McLean Center for Complementary and Alternative Medicine,PLC
-
Contact:
- Arthur Y Fan, MD(CHN),PhD
- Phone Number: 703-499-4428
- Email: ArthurFan@ChineseMedicineDoctor.us
-
Contact:
- Sarah F Alemi, DAc,LAc
- Phone Number: Alemi 7035478197
- Email: ArthurFan@ChineseMedicineDoctor.us
-
Principal Investigator:
- Arthur Y Fan, MD(CHN), PhD
-
Sub-Investigator:
- Sarah F Alemi, DAc, LAc
-
Sub-Investigator:
- Yingping H Zhu
-
Sub-Investigator:
- Sudaba Rahimi
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- diagnosis of generalized vulvodynia or provoked vestibulodynia by OB/GYN doctor(s) or pain specialist(s); 18 to 45 years old.
- Current pain score 4 or higher with tampon insertion and removal performed, or cotton swab test, at the initial screening exam
- speak and read English or Chinese.
Exclusion Criteria:
- infectious conditions of the vulvar/vagina;
- inflammatory conditions of the vulvar/vagina;
- neoplastic disorders of the vulvar/vagina;
- neurologic disorders of the vulvar/vagina;
- acute trauma to the genitals;
- iatrogenic conditions of the genitals
- hormonal deficiencies
- co-morbid pelvic pain conditions (to avoid confounding pain outcomes) such as pelvic inflammatory disease and documented history of endometriosis
- menopause
- patients have active migraine headaches, temporomandibular joint disease (TMJ), irritable bowel syndrome (IBS), interstitial cystitis, painful bladder syndrome, or fibromyalgia, in past 6 month.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Group1a, Acupuncture on Vulvodynia
Focus on using the local points in pudendal nerve distribution area
|
Needle size: #32(0.22
mm), 1-1.5 inch(30-40 mm long); Acupuncture time and frequency: 45 min per session, once or twice per week, for 6-12 sessions total (in 6 weeks).
Other Names:
|
Active Comparator: Group1b, Acupuncture on Vulvodynia
Focus on traditional acupuncture using common meridian or distal points
|
Needle size: #32(0.22
mm), 1-1.5 inch(30-40 mm long); Acupuncture time and frequency: 45 min per session, once or twice per week, for 6-12 sessions total (in 6 weeks).
Other Names:
|
Active Comparator: Group2, Standard care or waiting lists
Standard care without acupuncture
|
PT, pain medications, nerve block, etc
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain Score (objective)
Time Frame: at the end of 6 weeks
|
Figure out the pain score using Visual Analog pain scale(VAS) using cotton swab , [score 0-no pain, 10-strongest (unbearable) pain].
Expected clinical significant difference (ECSD): 3.
|
at the end of 6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain Score (Subjective)
Time Frame: at the end of 6 weeks
|
Figure out the pain score using Visual Analog pain scale(VAS) before use of cotton swab to to test pain , [score 0-no pain, 10-strongest (unbearable) pain].
Expected clinical significant difference (ECSD): 3.
|
at the end of 6 weeks
|
Pain duration
Time Frame: at the end of 6 weeks
|
Monitor the hours of pain per day
|
at the end of 6 weeks
|
Intercourse pain
Time Frame: at the end of 6 weeks
|
Record how much pain during intercourse using Visual Analog pain scale(VAS) [score 0-no pain, 10-strongest]
|
at the end of 6 weeks
|
Collaborators and Investigators
Investigators
- Principal Investigator: Arthur Y Fan, MD(CHN),PhD, McLean Center for Complementary and Alternative Medicine, PLC
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- McLeanCCAM01
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Vulvodynia
-
University Hospital, GhentCompletedLocalized Provoked VulvodyniaBelgium
-
Oregon Health and Science UniversityMedical Research Foundation, OregonCompleted
-
Meir Medical CenterCompleted
-
Meir Medical CenterCompletedLocalized Provoked VulvodyniaIsrael
-
Uppsala UniversityCompletedVulvodynia, Generalized | Provoked VestibulodyniaSweden
-
Oregon College of Oriental MedicineOregon Health and Science University; National Vulvodynia Association; Council...CompletedVulvodynia | Vulvar Vestibulitis | Provoked Vestibulodynia | Provoked, Localized VulvodyniaUnited States
-
University of Illinois at ChicagoUniversity of FloridaCompletedVulvodynia | Vulvar Vestibulitis | Vulvodynia, GeneralizedUnited States
-
Colleen StockdaleTerminatedVulvar Pain Symptoms | Vulvodynia (Chronic Vulvar Pain)United States
-
University of TennesseeUniversity of Tennessee Health Science CenterCompleted
-
Western Galilee Hospital-NahariyaCompleted
Clinical Trials on Acupuncture
-
University of ZurichCharite University, Berlin, Germany; First Teaching Hospital of Tianjin University...CompletedExperimental Dental PainSwitzerland
-
Federal University of São PauloCompleted
-
Chang Gung Memorial HospitalRecruitingIntracranial HemorrhagesTaiwan
-
University of SkövdeCompleted
-
National Research Centre of Complementary and Alternative...Norwegian Acupuncture CollegeUnknown
-
Chengdu University of Traditional Chinese MedicineChongqing Medical University; Hunan University of Traditional Chinese MedicineCompletedFunctional Dyspepsia | Postprandial Distress SyndromeChina
-
University of MichiganMassachusetts General Hospital; National Center for Complementary and Integrative...Completed
-
Huazhong University of Science and TechnologyThe University of Hong Kong; Heilongjiang University of Chinese Medicine; Hubei...CompletedPolycystic Ovary SyndromeChina
-
China Medical University HospitalNot yet recruiting
-
Mike O'Callaghan Military HospitalCompleted