The Use of Low Intensity Shock Wave Therapy for the Treatment of Provoked Vestibulodynia Disorder (PVD)
Condition: Provoked Vestibulodynia
MeSH terms: Vulvodynia; Vulvar Vestibulitis
Study type: Interventional

Summary: 
      Provoked vestibulodynia (PVD) is an exhausting pain syndrome that immensely affects quality
      of sexual life, and consequently negatively affects quality of life. Low intensity shock wave
      therapy produces physical forces that lead to pain relief.

      Aim: To evaluate the feasibility, safety and efficacy of low-intensity shockwave therapy in
      patients with provoked vestibulodynia.

      Methods: A double-blinded, randomized, sham-controlled, prospective study of 32 women. The
      treatment protocol included a series of treatments, performed twice a week for 6 weeks. Each
      treatment consisted of 500 pulses of low intensity shockwaves (0.09 mJ/〖mm〗^2 ) using the
      "Medispec ED-1000®" shock wave generator or sham.
    

Detailed description: 
      The study was a single center, double-blinded, randomized, sham-controlled, prospective
      study. Study eligibility criteria were treatment at the Neuro-urology Unit in Rambam Medical
      Center, during January 2018 - January 2020 and a diagnosis of PVD. PVD diagnosis was based on
      description of the pain and on a positive cotton swab test15.

      Women were randomized at a 2:1 ratio to treatment or sham groups. The treatment protocol
      included a series of treatments, performed twice a week for 6 weeks, for a total of 12
      sessions. Each treatment consisted of 500 pulses of low intensity shockwaves (0.09
      millijoul/〖mm〗^2 ) using the "Medispec ED-1000®" shock wave generator. The sham protocol
      included the same treatment protocol without shock wave generator activation. The patients
      were evaluated three times throughout the trial by an investigator blinded to the group
      allocation: before the first treatment, and one and three months after the twelfth treatment.
      Pain was assessed by both subjective and objective measures. The primary outcome measure was
      a change in dyspareunia, as assessed by scores on the 10-point visual analogue scale (VAS)
      (range 0-10 ).

      Secondary outcome measures for evaluating pain were increases in pain threshold and
      tolerance, assessed by a quantitative validated algometer test16, 17, the Wong-Baker pain
      FACES scale (range 0-10)18, the Female Sexual Function Index (FSFI) (range 2-38)19 and the
      Patients' Global Impression of Change scale (PGIC) (first component range 0-7; 0=no change,
      7=a great deal better; second component range 0-10; 0=much better and 10=much worse)20. The
      PGIC assessed the self-reported impression of a general change due to the intervention.

      The algometer applied was a very basic and simple device that was assembled and used at our
      unit after validating its safety, accuracy, and adequacy in evaluating introitus pain vs
      control (doctorate dissertation). For assessing the pain threshold with the algometer, radial
      pressure (mmHg) was applied by progressively inflating a cylindrical balloon inserted in the
      introitus. The participant was required to report the first painful sensation, and this
      pressure, defined as the threshold pressure, was registered. The measurement was performed
      sequentially 4 times and the average of the measured pressures was considered the first pain
      threshold). Finally, for pain tolerance measurement, the participant was again asked to
      report when she had reached her pain limit (1-10 on the verbal scale ) upon continuous
      pressure
    

Intervention name(s): Shockwave treatment
Intervention type(s): Device
Intervention description(s): ED 1000 shockwave generator
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A double-blinded, randomized, sham-controlled, prospective study
Masking: Double (Participant, Investigator)
Primary purpose: Treatment