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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

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 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
210 Previous Clinical Trials
268,161 Total Patients Enrolled
Linda McLeanPrincipal InvestigatorUniversity of Ottawa
2 Previous Clinical Trials
175 Total Patients Enrolled
~6 spots leftby Jul 2025