Provoked, Localized Vulvodynia Treatment With Acupuncture and Lidocaine Pilot Study
Condition: Provoked, Localized Vulvodynia; Provoked Vestibulodynia; Vulvar Vestibulitis; Vulvodynia
MeSH terms: Vulvodynia; Vulvar Vestibulitis
Study type: Interventional
Phase: Phase 1

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Classical Acupuncture; Non-classical acupuncture; Lidocaine
Intervention type(s): Procedure; Procedure; Drug
Intervention description(s): 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.
Other intervention name(s): 5% Lidocaine cream
Intervention MeSH terms: Lidocaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Vulvodynia; Provoked, localized vulvodynia; vulvar vestibulitis; provoked vestibulodynia; vulvovaginal pain; vulvar pain; vaginal pain; chronic pain; lidocaine; numbing agent; anesthetic cream; acupuncture; electroacupuncture; electrical stimulated acupuncture; manual acupuncture; classical acupuncture; non-classical acupuncture; Traditional Chinese Medicine; TCM; Chinese medicine; Acupuncture and Oriental Medicine; AOM; treatment; feasibility; pilot study; Patient Reported Outcomes Measure Information System; Tampon Test; cotton swab test; pain diary; Research Electronic Data Capture; REDCap