Low Level Laser Therapy Group for Provoked Vestibulodynia

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Provoked VestibulodyniaLow Level Laser Therapy - Other
Eligibility
18+
Female
What conditions do you have?
Select

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

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

6 Primary · 8 Secondary · Reporting Duration: 12 weeks (after the intervention)

Week 12
Adherence to the intervention protocol
12 weeks (following intervention)
Vulvodynia
Week 12
Female Sexual Function Index (FSFI)
Global Patient satisfaction with treatment
Global perception of improvement
Vagina
The Vulvar Pain Assessment Questionnaire (VPAQ) Inventory:COMPREHENSIVE (FULL) VERSION
The Vulvar Pain Assessment Questionnaire - Supplemental Domains
Week 12
Activation of the pelvic floor muscles (PFMs) during a bearing down maneuver
Anticipatory responses (ms) to pressure applied at the vulvar vestibule
Behavioural responses (µV) to pressure applied at the vulvar vestibule
Central sensitization index
Cortical silent period (ms)
Depression Anxiety Stress Scale (DASS)
Maximum voluntary activation of the pelvic floor muscles (PFMs)
Motor evoked potential (MEP) peak to peak amplitude (µV)
Pain
Pain
Temporal summation of pain
Tonic activation of the pelvic floor muscles (PFMs)

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

Low Level Laser Therapy Group
1 of 2
Sham Low Level Laser Therapy Group
1 of 2

Experimental Treatment

Non-Treatment Group

60 Total Participants · 2 Treatment Groups

Primary Treatment: Low Level Laser Therapy Group · Has Placebo Group · N/A

Low Level Laser Therapy Group
Other
Experimental Group · 1 Intervention: Low Level Laser Therapy · Intervention Types: Other
Sham Low Level Laser Therapy Group
Other
ShamComparator Group · 1 Intervention: Sham Low Level Laser Therapy · Intervention Types: Other

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 12 weeks (after the intervention)

Who is running the clinical trial?

University of OttawaLead Sponsor
178 Previous Clinical Trials
247,072 Total Patients Enrolled
BioFlexTM Laser TherapyUNKNOWN
Linda McLeanPrincipal InvestigatorUniversity of Ottawa
1 Previous Clinical Trials
120 Total Patients Enrolled

Eligibility Criteria

Age 18+ · Female Participants · 7 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are biologically born female older than 18 years.
You have no neurological condition such as stroke, multiple sclerosis, spinal cord injury, epilepsy or history of epilepsy in the family.
You have symptoms consistent with vestibulodynia alone or provoked vestibulodynia plus vaginismus.
References