Provoked Vestibulodynia Clinical Trial
Official title:
The Use of Low Intensity Shock Wave Therapy for the Treatment of Provoked Vestibulodynia Disorder (PVD)
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.
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
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT01704456 -
Integrated Mindfulness-based Cognitive Behaviour Therapy Versus Cognitive Behaviour Therapy for Provoked Vestibulodynia
|
N/A | |
Completed |
NCT02543593 -
Efficacy of Transcranial Direct-Current Stimulation (tDCS) for Provoked Vestibulodynia : a Triple Blind Randomized Controlled Trial
|
N/A | |
Completed |
NCT01996384 -
Provoked, Localized Vulvodynia Treatment With Acupuncture and Lidocaine Pilot Study
|
Phase 1 | |
Completed |
NCT01731288 -
Pregnancy, Childbirth Intentions and Outcomes Under Sexual Pain
|
N/A | |
Terminated |
NCT01149031 -
Low Level Laser Therapy for the Treatment of Provoked Vestibulodynia
|
N/A | |
Completed |
NCT01753258 -
Outcomes of Delivery in Patients With Dyspareunia
|
N/A | |
Completed |
NCT04045041 -
Internet-based Treatment for Provoked Vestibulodynia
|
N/A | |
Recruiting |
NCT05797480 -
Dry Needling for Provoked Vestibulodynia
|
N/A | |
Recruiting |
NCT05909514 -
Investigating the Effectiveness of PelvicSense(R) on Pain and Sexual Outcomes in Provoked Vestibulodynia
|
N/A | |
Completed |
NCT04234542 -
Is Low Level Laser Therapy (LLLT) Effective for Reducing Pain Experienced by Women With Provoked Vestibulodynia?
|
N/A | |
Completed |
NCT04208204 -
Somatocognitive Therapy in Treatment of Provoked Vestibulodynia - a Feasibility Study
|
N/A | |
Completed |
NCT01704443 -
Integrated Mindfulness for Provoked Vestibulodynia
|
N/A |