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Is Low Level Laser Therapy (LLLT) Effective for Reducing Pain Experienced by Women With 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 intervention)

Summary

This trial tests if Low Level Laser Therapy (LLLT) can reduce pain and improve sexual function in women with provoked vestibulodynia (PVD) or PVD with vaginismus. LLLT uses red and infrared light to help repair cells. Low-level laser therapy (LLLT) has been used for various conditions requiring pain relief, inflammation reduction, and tissue repair.

Eligible Conditions

Vulvodynia

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 weeks (after intervention)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 weeks (after intervention)

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

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Global perception of improvement

Pain

Vagina

+3 more

Secondary study objectives

Central sensitization index

Cortical silent period (ms)

Depression Anxiety Stress Scale (DASS)

+5 more

Other study objectives

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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