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Low Level Laser Therapy Group for Provoked Vestibulodynia

N/A

Waitlist Available

Led By Linda McLean

Research Sponsored by University of Ottawa

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 weeks (after the intervention)

Awards & highlights

Study Summary

This trial is being done to see if low level laser therapy is an effective treatment for provoked vestibulodynia, a type of vulvar pain that affects around 1 in 10 women and causes pain during sex or attempts to insert something into the vagina. The trial will involve 80 women who will be given either the therapy or a sham therapy, and will be evaluated before and after the intervention period.

Eligible Conditions

Provoked Vestibulodynia

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 weeks (following intervention)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 weeks (following intervention)

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks (following intervention) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Global perception of improvement

Pain

Vagina

+3 more

Secondary outcome measures

Central sensitization index

Cortical silent period (ms)

Depression Anxiety Stress Scale (DASS)

+5 more

Other outcome measures

Activation of the pelvic floor muscles (PFMs) during a bearing down maneuver

Adherence to the intervention protocol

Anticipatory responses (ms) to pressure applied at the vulvar vestibule

+3 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Low Level Laser Therapy GroupExperimental Treatment1 Intervention

15 treatments will be provided over a 12 week period using a protocol developed in collaboration with BioFlexTM Laser. Each treatment will last approximately 45 minutes and will include the laser array first being applied to the skin overlying the sacral spine in a horizontal placement then in oblique placement bilaterally (red and infrared light) while a laser probe is applied over the base of the spine (red and infrared light). Next, the array will be applied to the surface of the perineum (red and infrared light) and the focal probe will be applied to painful sites on the perineum. Finally, the infrared light probe will be applied to the skin overlying branches of the pudendal nerve. All the stages will involve use of the same array and probe placement, but at each stage the dosage will be increased according to the BioFlex protocol. During teach treatment session, women will listen to an audio recording of a mindfulness-based meditation on CD through noise cancelling headphones.

Group II: Sham Low Level Laser Therapy GroupPlacebo Group1 Intervention

15 treatments will be provided over a 12 week period using the same protocol developed in collaboration with BioFlexTM Laser, but at an intensity of 1% output for all sites and at all stages. Each treatment will last approximately 45 minutes. At each visit, the laser array will first be applied to the skin overlying the sacral spine in a horizontal then oblique placement bilaterally (red and infrared light) concurrently with a laser probe applied over the base of the spine (red and infrared light). Next, the array will be applied to the surface of the perineum (red and infrared light), followed by treatment at specific painful sites using the red light probe. Finally, the infrared light probe will be applied to the skin overlying branches of the pudendal nerve. Participants randomized to this group will listen to an audio recording of a mindfulness-based meditation on CD through noise cancelling headphones while receiving the sham laser treatment.

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Who is running the clinical trial?

BioFlexTM Laser TherapyUNKNOWN

University of OttawaLead Sponsor

205 Previous Clinical Trials

266,063 Total Patients Enrolled

Linda McLeanPrincipal InvestigatorUniversity of Ottawa

2 Previous Clinical Trials

175 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current enrolment capacity of this clinical research?

"Affirmative. According to the information collected on clinicaltrials.gov, this medical examination is currently searching for participants - it was initially published in February 18th 2021 and last altered on September 27th 2021. There are 60 patients required from 1 particular research centre."

Answered by AI

What is the ultimate aim of this clinical experiment?

"The primary aim of this medical trial, should funding become available to support it for a 12-week period post intervention, is the evaluation of Vulvar Pain Assessment Questionnaire (VPAQ) Inventory by means of its Comprehensive Version. Secondary objectives comprise assessing participants' levels of pain catastrophizing using the Pain Catastrophizing Scale -a self-report measure with 13 items scored from 0 to 4 and resulting in a maximum score of 52; ascertaining global patient satisfaction regarding treatment through an ordinal rating scale; and gauging female sexual function via Female Sexual Function Index (FSFI), which consists on 19 questions compiled into six domains"

Answered by AI

Are new participants being admitted to this trial currently?

"This clinical trial, which was first made available to potential participants on February 18th 2021, is presently recruiting patients. The most recent update of the study's information can be found on clinicaltrials.gov and dates back to September 27th 2021."

Answered by AI

Recent research and studies

The Journal of Sexual MedicineJournal

Pelvic Floor Muscle Assessment Outcomes in Women with and Without Provoked Vestibulodynia and the Impact of a Physical Therapy Program

Gentilcore-Saulnier, Evelyne, Linda McLean, Corrie Goldfinger, Caroline F. Pukall, and Susan Chamberlain. 2010. “Pelvic Floor Muscle Assessment Outcomes in Women with and Without Provoked Vestibulodynia and the Impact of a Physical Therapy Program”. The Journal of Sexual Medicine. Elsevier BV. doi:10.1111/j.1743-6109.2009.01642.x.

Sexual Medicine ReviewsJournal

What Does Electromyography Tell Us About Dyspareunia?

McLean, Linda, and Kaylee Brooks. 2017. “What Does Electromyography Tell Us About Dyspareunia?”. Sexual Medicine Reviews. Elsevier BV. doi:10.1016/j.sxmr.2017.02.001.

Journal of Sex & Marital TherapyJournal

The Female Sexual Function Index (FSFI): A Multidimensional Self-report Instrument for the Assessment of Female Sexual Function

Rosen, C. Brown, J. Heiman, S. Leib, R.. 2000. “The Female Sexual Function Index (FSFI): A Multidimensional Self-report Instrument for the Assessment of Female Sexual Function”. Journal of Sex & Marital Therapy. Informa UK Limited. doi:10.1080/009262300278597.

Behaviour Research and TherapyJournal