The Use of Low Intensity Shock Wave Therapy for the Treatment of Provoked Vestibulodynia Disorder (PVD)
Primary Purpose
Provoked Vestibulodynia
Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Shockwave treatment
Sponsored by
About this trial
This is an interventional treatment trial for Provoked Vestibulodynia
Eligibility Criteria
Inclusion Criteria:
- Above age 18 years
- Diagnosis of provoked vestibulodynia by a gynecologist at least 3 month prior to study date
- Positive cotton swab test
- Pain during intercourse/ tampon insertion, gynecologic examination
- Cognitively and physically adapted for undergoing treatment
Exclusion Criteria:
- Pregnancy or lactating
- History of pelvic or external genitalia irradiation during the past year
- Any chronic neurological disorder causing local pain
- Any pelvic inflammatory process
- Any psychiatric disorders
- Investigators impression of patient being eligible for the study (non compliance etc..)
Sites / Locations
- Rambam Healthcare Campus
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
active
sham
Arm Description
A shockwave device with a probe that conveys shockwave energy
A shockwave device with specially designed probe which has the shockwave energy blocked
Outcomes
Primary Outcome Measures
Visual Analog Scale (VAS)
The primary outcome was a change in dyspareunia, as assessed by scores on the 10-point Visual Analogue Scale where 1 is the minimum score meaning painless and 10 is the maximum score meaning excruciating pain
Secondary Outcome Measures
Algometer testing
measures threshold of pain in mmHg, where any threshold below 100 mmHg is considered pathological
Wong-Baker pain FACES scale
from a scale of 1 to five showing sad face for score 1 and very happy face for score 5
Female Sexual Function Index (FSFI)
A validated questionnaire assessing female sexual dysfunction, any score above 22.5 is pathological
Patients' Global Impression of Change scale.
one question with a scale from -3 to+3 where 0 is not better nor worse, -3 is much worse and +3 is much better
Full Information
NCT ID
NCT04545255
First Posted
August 20, 2020
Last Updated
September 3, 2020
Sponsor
Rambam Health Care Campus
1. Study Identification
Unique Protocol Identification Number
NCT04545255
Brief Title
The Use of Low Intensity Shock Wave Therapy for the Treatment of Provoked Vestibulodynia Disorder (PVD)
Official Title
The Use of Low Intensity Shock Wave Therapy for the Treatment of Provoked Vestibulodynia Disorder (PVD)
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
June 21, 2018 (Actual)
Primary Completion Date
October 30, 2019 (Actual)
Study Completion Date
January 20, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rambam Health Care Campus
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Provoked Vestibulodynia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A double-blinded, randomized, sham-controlled, prospective study
Masking
ParticipantInvestigator
Masking Description
Shockwave probes were either active or sham (by blocking energy transfer from probe)
Allocation
Randomized
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
active
Arm Type
Active Comparator
Arm Description
A shockwave device with a probe that conveys shockwave energy
Arm Title
sham
Arm Type
Sham Comparator
Arm Description
A shockwave device with specially designed probe which has the shockwave energy blocked
Intervention Type
Device
Intervention Name(s)
Shockwave treatment
Intervention Description
ED 1000 shockwave generator
Primary Outcome Measure Information:
Title
Visual Analog Scale (VAS)
Description
The primary outcome was a change in dyspareunia, as assessed by scores on the 10-point Visual Analogue Scale where 1 is the minimum score meaning painless and 10 is the maximum score meaning excruciating pain
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Algometer testing
Description
measures threshold of pain in mmHg, where any threshold below 100 mmHg is considered pathological
Time Frame
1 year
Title
Wong-Baker pain FACES scale
Description
from a scale of 1 to five showing sad face for score 1 and very happy face for score 5
Time Frame
1 year
Title
Female Sexual Function Index (FSFI)
Description
A validated questionnaire assessing female sexual dysfunction, any score above 22.5 is pathological
Time Frame
1 year
Title
Patients' Global Impression of Change scale.
Description
one question with a scale from -3 to+3 where 0 is not better nor worse, -3 is much worse and +3 is much better
Time Frame
1 year
10. Eligibility
Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Above age 18 years
Diagnosis of provoked vestibulodynia by a gynecologist at least 3 month prior to study date
Positive cotton swab test
Pain during intercourse/ tampon insertion, gynecologic examination
Cognitively and physically adapted for undergoing treatment
Exclusion Criteria:
Pregnancy or lactating
History of pelvic or external genitalia irradiation during the past year
Any chronic neurological disorder causing local pain
Any pelvic inflammatory process
Any psychiatric disorders
Investigators impression of patient being eligible for the study (non compliance etc..)
Facility Information:
Facility Name
Rambam Healthcare Campus
City
Haifa
State/Province
Northern Region
ZIP/Postal Code
31096
Country
Israel
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
18209522
Citation
Landry T, Bergeron S, Dupuis MJ, Desrochers G. The treatment of provoked vestibulodynia: a critical review. Clin J Pain. 2008 Feb;24(2):155-71. doi: 10.1097/AJP.0b013e31815aac4d.
Results Reference
result
PubMed Identifier
19170850
Citation
Sutton KS, Pukall CF, Chamberlain S. Pain, psychosocial, sexual, and psychophysical characteristics of women with primary vs. secondary provoked vestibulodynia. J Sex Med. 2009 Jan;6(1):205-14. doi: 10.1111/j.1743-6109.2008.01038.x.
Results Reference
result
Learn more about this trial
The Use of Low Intensity Shock Wave Therapy for the Treatment of Provoked Vestibulodynia Disorder (PVD)
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