Is Localized Provoked Vulvodynia Caused by Laxity of the Utero-Sacral Ligaments?
Condition: Vulvodynia; Referred Pain
MeSH terms: Vulvodynia; Pain, Referred
Study type: Interventional

Summary: 
      Small-scale experiments conducted by our group have led to the hypothesis that Localized
      Provoked Vulvodynia (LPV) may be due to laxity of the Utero-Sacral ligaments (USL). According
      to this hypothesis, the pain experienced by women with LPV is due to the USL's inability to
      provide appropriate support for the pudendal nerve.

      In order to test this hypothesis we will conduct a single-blind randomized control trial in
      which patients with LPV will undergo a pressure-test - pressure will be temporarily applied
      to the posterior fornix using a large-sized applicator, thus strengthening the USL and adding
      support to the pudendal nerve. While the pressure is being applied, the cotton-swab test will
      be performed (palpating vulvar and vestibular sites using a cotton-swab), and each patient
      will rate the elicited pain on a scale of 1 to 10 (1 - not painful, 10 - worst pain
      imaginable).

      The results for each patient will be compared to their baseline level of pain (which will be
      recorded in the beginning of the experiment) and to the level of pain they report while
      inserting a speculum but not applying any pressure.
    

Detailed description: 
      Patients with LPV who sign an informed consent form will first undergo the cotton-swab test
      during which they will rate the pain elicited on a scale of 1 to 10. This score will be used
      as the patient's baseline level of pain for data analysis later. Then, each patient will be
      randomized into one of two groups: One group which will first undergo the control
      manipulation and then the study manipulation, or the second group in which the study
      manipulation will precede the control manipulation. This is done to neutralize a possible
      effect of the order of the manipulations on the trial's results when the data will be
      analyzed.

      The control manipulation: Inserting a speculum into the vagina without applying pressure.

      The study manipulation: First inserting a speculum, then inserting through it a large-sized
      applicator reaching the posterior fornix, then retrieving the speculum while keeping the
      applicator in place, and then applying significant pressure to the posterior fornix.

      During each of the manipulations, the cotton-swab test will be performed again, and each
      patient will be asked to rate the level of pain elicited by the test. All data will be
      recorded, and we will later analyze if there was a significant difference between the pain
      elicited by the cotton-swab test during the study manipulation compared with the control
      manipulation, or compared with the baseline test.
    

Intervention name(s): Pressure-test
Intervention type(s): Procedure
Intervention description(s): Pressure will be applied to the posterior fornix using a speculum.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Diagnostic
Keywords: Vulvodynia; Localized Provoked Vulvodynia (LPV); Referred pain; Utero-Sacral ligaments laxity