A Phase 1 interventional study of Classical Acupuncture and Non-classical acupuncture in Provoked, Localized Vulvodynia, Provoked Vestibulodynia and Vulvar Vestibulitis, sponsored by Oregon College of Oriental Medicine. Completed at 1 site in United States. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2017-10-06.
Sponsored by Oregon College of Oriental Medicine · Phase 1, Interventional, and Treatment
The investigators research project is a randomized, controlled, single-blinded, feasibility pilot study. The investigators will study the feasibility of a novel treatment for women with Provoked Localized Vulvodynia (PLV) with acupuncture and 5% lidocaine cream. Lidocaine is a numbing agent and common first treatment for this disorder. Acupuncture is a treatment commonly used for other pain disorders. The investigators will compare two types of acupuncture (classical and non-classical) as a treatment for PLV, in addition to 5% lidocaine cream. Researchers want to determine if acupuncture is acceptable and convenient to women with PLV. The investigators hypothesize that classical acupuncture and 5% lidocaine cream will be better than non-classical acupuncture and 5% lidocaine cream to decrease PLV pain.
This is a randomized, controlled, single-blinded, pilot trial to study the feasibility and acceptability of acupuncture and 5% lidocaine. Patients will be recruited from the patient population of the Oregon Health \& Science University Vulvar Health Clinic. Thirty (30) patients with PLV will be enrolled as study participants into the study. Fifteen (15) will be allocated in the treatment (classical) acupuncture + 5% lidocaine group and fifteen (15) will be allocated in the control (non-classical) acupuncture + 5% lidocaine group via a computer generated randomization program to balance allocation based on four variables: pain intensity, smoking status, body mass index, and pain duration.
The acupuncturist will interview each patient and perform an exam of the pulse and tongue. A standardized acupuncture treatment will be assigned, and both groups will receive 18 acupuncture treatments that follow a standardized protocol on classical or non-classical acupuncture points, with or without mild electrical stimulation. All study participants will self-apply lidocaine cream to their genital region four times daily during the study.
106 studies on the registry are indexed under Vulvodynia; 21 are open to participants now.
This study's enrollment of 19 is below the median of 44 across 79 interventional studies indexed under Vulvodynia.
Browse Vulvodynia studies →This is the only study on the registry with Oregon College of Oriental Medicine as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Study participants will attend 18 classical acupuncture sessions, twice a week for Weeks 1-6, and once a week for Weeks 7-12. A standardized acupuncture treatment will be assigned with classical acupuncture points and may or may not be stimulated with electroacupuncture. Very thin needles (0.18mm) will be inserted into locations either on the front or the back of the body and may be placed near or far from the affected area based on up to three Traditional Chinese Medicine Diagnosis categories. Study participants will also be asked to gently apply 5% lidocaine cream four times daily (breakfast, lunch, dinner, and before bed).
Procedure: Classical Acupuncture · Drug: Lidocaine
Study participants will attend 18 non-classical acupuncture sessions, twice a week for Weeks 1-6, and once a week for Weeks 7-12. A standardized acupuncture treatment will be assigned with non-classical acupuncture points and may or may not be stimulated with electroacupuncture. Very thin needles (0.18mm) will be inserted into locations either on the front or the back of the body and may be placed near or far from the affected area. Study participants will also be asked to gently apply 5% lidocaine cream four times daily (breakfast, lunch, dinner, and before bed).
Procedure: Non-classical acupuncture · Drug: Lidocaine
Very thin needles (0.18mm) will be inserted into locations either on the front or the back of the body and may be placed near or far from the affected area. No needles will be inserted into the genital region. Locations needled will be in classical acupuncture points. On even-numbered visits, the needles may be electrically stimulated via an electro-acupuncture machine. Needles will be retained for 30 minutes per study visit. Acupuncture needles used are 0.18x30-40mm, manufactured by Dong Bae Corporation (DBC), Korea. The electrical acupuncture device is Pantheon Research Electrical Stimulator 8c, United States.
Very thin needles (0.18mm) will be inserted into locations either on the front or the back of the body and may be placed near or far from the affected area. No needles will be inserted into the genital region. Locations needled will be in non-classical acupuncture points. On even-numbered visits, the needles may be electrically stimulated via an electro-acupuncture machine. Needles will be retained for 30 minutes per study visit. Acupuncture needles used are DBC Brand, Korea, 0.18x30-40mm. The electrical acupuncture device is Pantheon Research Electrical Stimulator 8c, United States.
Study participants will gently apply 5% lidocaine cream four times daily to vulvar area.
Also known as: 5% Lidocaine cream
Tampon Test
Primary outcome variable will be to measure the change in the reported pain of the "Tampon Test" (mean at Week 1) to the reported pain of "Tampon Test" (mean of Week 12); Every week, study participants will be asked to fully insert and remove a tampon and rate the level of pain with insertion on a 10-point Visual Analog Scale (0 indicating no pain, 10 indication worst possible pain).
Time frame: Weeks 1 and 12 study period
Cotton Swab test
Secondary outcome variable will compare the "Cotton Swab Test" with a blinded assessor reported pain at three timepoints. 1) change in reported pain at (mean at Weeks -2, -1, 0, and 1) to the reported pain (mean at Weeks 12 and 13; 2) change in reported pain (means Weeks -2, -1, 0, and 1) to the reported pain (mean at Week 24); 3) change in reported pain (mean at Week 12) to (mean at Week 24). Vestibular tenderness will be assessed by light touch with a cotton swab by a blinded assessor to the study participant's: 1) vestibule (cotton swab test) at four defined points (1:00, 5:00, 7:00, and 11:00); 2) the perineum; 3) labia majora (2:00 and 8:00), and 4) labia minora (4:00 and 10:00). Tenderness at each location will be rated by the Study Participant on a 10-point scale (0 indicating no pain, 10 indicating worst possible pain).
Time frame: Weeks -4, -3, -2, -1, 0, 1, 12 or 13 and 24.
Patient Reported Outcomes Measurement Information System (PROMIS) Scales
Assess changes in scores quality of life, vaginal discomfort, pain intensity, pain interference and behavior, anxiety, and depression at 6 weeks, 12 weeks, and 24 weeks compared to baseline.
Time frame: At baseline visit, 6 weeks, 12 weeks, and 24 weeks
Satisfaction
Using 5-point scales (Very satisfied, satisfied, neither satisfied nor dissatisfied, dissatisfied, Very dissatisfied), Study participants will be asked how satisfied they are with the study interventions and how satisfied they are with their pain relief.
Time frame: Weeks 12 and 24
Expectation
Study participants will be asked about how much they 'expect' the study interventions will or will not help, how much they 'think' the intervention will or will not help, and how much they 'feel' about the intervention will or will not help via 10-point scales.
Time frame: Week 1
Feasibility
Assess feasibility by the number of study participants enrolled.
Time frame: Weeks 12 and 24
Acceptability
Assess acceptability by the number of study visits attended by participants enrolled.
Time frame: Weeks 12 and 24
Tampon Test
Secondary outcome variables will be to: 1. measure the change in reported pain of the "Tampon Test" (mean at Week 1) to the reported pain of "Tampon Test" (mean of Week 6); 2. measure the change in reported pain of the "Tampon Test" (mean at Week 1) to the reported pain of "Tampon Test" (mean of Week 24); 3. measure the change in reported pain of the "Tampon Test" (mean at Week 12) to the reported pain of "Tampon Test" (mean of Week 24). Every week, study participants will be asked to fully insert and remove a tampon and rate the level of pain with insertion on a 10-point Visual Analog Scale (0 indicating no pain, 10 indication worst possible pain).
Time frame: Weeks 1 and 6; Weeks 1 and 24
Traditional Chinese Medicine (TCM) Diagnosis Category
TCM Diagnosis Category will be recorded and tracked by the primary investigator to determine if it may be a potential predictor of treatment response.
Time frame: Week 1
24-hour mean pain score
In a daily pain diary, study participants will be asked to record the level of pain they are experiencing based via the 10-point VAS scale (0 indicates no pain, 10 indicates worst possible pain).
Time frame: Baseline, Weeks 6, 12, and 24
Frequency of intercourse
In a daily pain diary, study participants will be asked to record if they engaged in intercourse within the last 24 hours.
Time frame: Baseline, Weeks 6, 12, and 24
Intensity of Intercourse pain
In a daily pain diary, study participants will be asked to record the level of pain they are experienced with intercourse based via the 10-point VAS scale (0 indicates no pain, 10 indicates worst possible pain).
Time frame: Baseline, Weeks 6, 12, and 24
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