Provoked, Localized Vulvodynia Treatment With Acupuncture and Lidocaine Pilot Study

• Tampon Test [ Time Frame: Weeks 1 and 12 study period ] [ Designated as safety issue: No ]

  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).

  
  

• Cotton Swab test [ Time Frame: Weeks -4, -3, -2, -1, 0, 1, 12 or 13 and 24. ] [ Designated as safety issue: No ]

  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).

  
  
• Patient Reported Outcomes Measurement Information System (PROMIS) Scales [ Time Frame: At baseline visit, 6 weeks, 12 weeks, and 24 weeks ] [ Designated as safety issue: No ]
  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.
  
  
• Satisfaction [ Time Frame: Weeks 12 and 24 ] [ Designated as safety issue: No ]
  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.
  
  
• Expectation [ Time Frame: Week 1 ] [ Designated as safety issue: No ]
  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.
  
  
• Feasibility [ Time Frame: Weeks 12 and 24 ] [ Designated as safety issue: No ]
  Assess feasibility by the number of study participants enrolled.
  
  
• Acceptability [ Time Frame: Weeks 12 and 24 ] [ Designated as safety issue: No ]
  Assess acceptability by the number of study visits attended by participants enrolled.
  
  
• Tampon Test [ Time Frame: Weeks 1 and 6; Weeks 1 and 24 ] [ Designated as safety issue: No ]

  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).

  
  

• Traditional Chinese Medicine (TCM) Diagnosis Category [ Time Frame: Week 1 ] [ Designated as safety issue: No ]
  TCM Diagnosis Category will be recorded and tracked by the primary investigator to determine if it may be a potential predictor of treatment response.
  
  
• 24-hour mean pain score [ Time Frame: Baseline, Weeks 6, 12, and 24 ] [ Designated as safety issue: No ]
  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).
  
  
• Frequency of intercourse [ Time Frame: Baseline, Weeks 6, 12, and 24 ] [ Designated as safety issue: No ]
  In a daily pain diary, study participants will be asked to record if they engaged in intercourse within the last 24 hours.
  
  
• Intensity of Intercourse pain [ Time Frame: Baseline, Weeks 6, 12, and 24 ] [ Designated as safety issue: No ]
  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).
  
  

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.