Provoked, Localized Vulvodynia Treatment With Acupuncture and Lidocaine Pilot Study
| Status: | Completed |
|---|---|
| Conditions: | Infectious Disease |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - 45 |
| Updated: | 10/8/2017 |
| Start Date: | November 2013 |
| End Date: | March 2016 |
Acupuncture Augmentation of Lidocaine for the Treatment of Provoked, Localized vulvodynia-a Feasibility and Acceptability Pilot Study
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.
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.
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.
Inclusion Criteria:
- Literate, English speaking, premenopausal, women meeting Friedrich's criteria for
Provoked, localized vulvodynia
- Reported introital dyspareunia longer than three months duration;
- Average pain score greater than 4 on Visual Analog Scale (VAS) at enrollment with
cotton swab test and Tampon Test;
- Able to insert an Original Regular Tampax™ tampon.
Exclusion Criteria:
- Co-existing conditions leading to dyspareunia including generalized unprovoked
vulvodynia, atrophic vaginitis, vulvovaginal dermatoses (e.g. lichen sclerosus), or
genital infection (e.g. herpes simplex virus or yeast infection).
- Pregnant or postpartum and breastfeeding;
- Use of neuromodulator medications (e.g. Serotonin Norepinephrine Reuptake Inhibitors
(SNRIs), Tricyclic Antidepressants, or anti-seizure medications) started in the last
six months. If taken for longer, must be on a stable dose for at least six months and
still report moderate to severe pain. Selective Serotonin Reuptake Inhibitors (SSRIs)
are allowed;
- Postmenopausal as defined by surgical or natural menopause (no menses for 12 months);
- Chronic pelvic pain defined as daily, non-menstrual pain in pelvis or lower abdomen
for longer than three months duration;
- Must be able to refrain from other treatments for PLV including non-traditional
options (e.g. other medications, physical therapy, sex therapy, acupuncture,
naturopathic remedies) during the course of the study (6 months).
- Use of SNRIs, lidocaine, or acupuncture within the last three months.
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