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

NCT04234542 | Completed

• 1 other identifier: H-01-19-2367
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

Provoked vestibulodynia (PVD) is one major subtype of vulvar pain, affecting close to one in ten women and resulting in pain during attempts at vaginal intercourse and/or attempts to insert a digit, device or tampon into the vagina. Management involves a multidisciplinary approach, through physicians, psychologists, sex therapists and physiotherapists. Low Level Laser Therapy (LLLT) is a therapeutic modality involving irradiation of injured or diseased tissue with a combination of red and infrared light. This process is thought to initiate a series of physiological reactions within the cells exposed to light at these wavelengths, leading to the restoration of normal cell structure and function. The investigators hypothesize that LLLT will be effective at reducing pain and improving sexual function among women with PVD. The purpose of this double-blind randomized controlled trial is to assess the feasibility of using a LLLT intervention for the management of PVD in women. The aim is to determine whether there is evidence of a positive effect of LLLT, delivered using a BioFlexTM laser system (Health Canada Licence No. 7931) and a semi-standardized protocol, in terms of self-reported pain and sexual functioning, physiological responses to pressure applied at the vulvar vestibule, tonic and phasic activation of the PFM and/or corticomotor excitability to the PFMs in women with PVD with or without concurrent vaginismus (VAG) when compared to an identical treatment schedule where sham LLLT is delivered. Women will be recruited from among eighty women with confirmed PVD and PVD+VAG who participate in a cross sectional study investigating pelvic floor muscle involvement in PVD. If they are interested in participating in this intervention study, they will be asked to consent to having their data from the cross sectional study used for the purposes of this concurrent study. Women will be evaluated before the intervention using a battery of physical assessments and questionnaires, re-evaluated on primary outcome measures 3 weeks after initiating the intervention and then re-evaluated using the complete battery of physical assessment and questionnaires at the end of the intervention period. If we secure further funding, a medium term (12 weeks later) follow-up will be added. Physical assessment will include evaluation of pressure-pain threshold, temporal summation of pain, electromyographic (EMG) evaluation of PFM activity, responses of the PFMs to pressure applied at the vulvar vestibule using a custom electronic vulvalgesiometer, motor evoked potential threshold, amplitude, latency and the duration of cortically mediated silent period recorded from the PFMs following transcranial magnetic stimulation. The questionnaires will include the The Vulvar Pain Assessment Questionnaire (VPAQ), the Female Sexual Functioning Index, the Pain Catastrophizing Scale, the Depression Anxiety Stress Scales and the Central Sensitization Inventory. Three weeks and 12 weeks after the first start of treatment, the Global Perception of Improvement and Global patient satisfaction with treatment questionnaires will be administered. These will be repeated 12 weeks after completing treatment if funding becomes available.

Conditions

Provoked Vestibulodynia

Keywords

vulvar pain; pelvic floor; low level laser therapy; laser; transcranial magnetic stimulation; electromyography

Outcome Measures

Primary Outcomes (19)

• Global perception of improvement

  The Global perception of improvement is a single question through which participants provide a ordinal rating based on their overall perception of improvement attributed to the intervention. Much Better, Better, About the same, Worse, Much worse. Higher ratings is associated with better outcomes.

  3 weeks (during intervention)

• Global perception of improvement

  The Global perception of improvement is a single question through which participants provide a ordinal rating based on their overall perception of improvement attributed to the intervention. Much Better, Better, About the same, Worse, Much worse. Higher ratings is associated with better outcomes.

  12 weeks (following intervention)

• Global perception of improvement

  The Global perception of improvement is a single question through which participants provide a ordinal rating based on their overall perception of improvement attributed to the intervention. Much Better, Better, About the same, Worse, Much worse. Higher ratings is associated with better outcomes.

  12 weeks after intervention (if funding becomes available)

• The Vulvar Pain Assessment Questionnaire (VPAQ)Inventory:COMPREHENSIVE (FULL) VERSION

  Designed to assess: pain quality, the temporal nature of the pain, associated symptoms, pain intensity, emotional/cognitive functioning, physical functioning, coping strategies, and interpersonal functioning. Core Domains: Consists of 63 items:8 questions assessing the onset, location, temporal pattern, degree of burning pain, and associated symptoms of vulvar pain, along with six subscales. Subscales are composed of 55 items rated on 5-point scales with anchors tailored to the nature of the questions being asked: 1. Pain severity 2. Emotional response 3. Cognitive response 4. Life interference 5. Sexual function interference 6. Self-stimulation/penetration interference Each subscale is scored separately and is the average of the items. The lowest possible score is 0 (Not at all) and the highest is 4 (very much). Higher score means worse symptoms

  Baseline

• The Vulvar Pain Assessment Questionnaire (VPAQ)Inventory:COMPREHENSIVE (FULL) VERSION

  Designed to assess: pain quality, the temporal nature of the pain, associated symptoms, pain intensity, emotional/cognitive functioning, physical functioning, coping strategies, and interpersonal functioning. Core Domains: Consists of 63 items:8 questions assessing the onset, location, temporal pattern, degree of burning pain, and associated symptoms of vulvar pain, along with six subscales. Subscales are composed of 55 items rated on 5-point scales with anchors tailored to the nature of the questions being asked: 1. Pain severity 2. Emotional response 3. Cognitive response 4. Life interference 5. Sexual function interference 6. Self-stimulation/penetration interference Each subscale is scored separately and is the average of the items. The lowest possible score is 0 (Not at all) and the highest is 4 (very much). Higher score means worse symptoms

  3 weeks (during intervention)

• The Vulvar Pain Assessment Questionnaire (VPAQ)Inventory:COMPREHENSIVE (FULL) VERSION

  Designed to assess: pain quality, the temporal nature of the pain, associated symptoms, pain intensity, emotional/cognitive functioning, physical functioning, coping strategies, and interpersonal functioning. Core Domains: Consists of 63 items:8 questions assessing the onset, location, temporal pattern, degree of burning pain, and associated symptoms of vulvar pain, along with six subscales. Subscales are composed of 55 items rated on 5-point scales with anchors tailored to the nature of the questions being asked: 1. Pain severity 2. Emotional response 3. Cognitive response 4. Life interference 5. Sexual function interference 6. Self-stimulation/penetration interference Each subscale is scored separately and is the average of the items. The lowest possible score is 0 (Not at all) and the highest is 4 (very much). Higher score means worse symptoms

  12 weeks (following intervention)

• The Vulvar Pain Assessment Questionnaire (VPAQ) Inventory:COMPREHENSIVE (FULL) VERSION

  Designed to assess: pain quality, the temporal nature of the pain, associated symptoms, pain intensity, emotional/cognitive functioning, physical functioning, coping strategies, and interpersonal functioning. Core Domains: Consists of 63 items:8 questions assessing the onset, location, temporal pattern, degree of burning pain, and associated symptoms of vulvar pain, along with six subscales. Subscales are composed of 55 items rated on 5-point scales with anchors tailored to the nature of the questions being asked: 1. Pain severity 2. Emotional response 3. Cognitive response 4. Life interference 5. Sexual function interference 6. Self-stimulation/penetration interference Each subscale is scored separately and is the average of the items. The lowest possible score is 0 (Not at all) and the highest is 4 (very much). Higher score means worse symptoms

  12 weeks after intervention (if funding becomes available)

• Pain rating during the tampon test

  The participants will be provided with Original Regular Tampax Tampon and will be instructed to insert and then remove it. After, they will be asked to record the degree of pain during the entire insertion/removal experience in a 11-point numerical rating scale (NRS) with anchors of 0 (no pain at all) to 10 (worst pain imaginable).

  Baseline

• Pain rating during the tampon test

  The participants will be provided with Original Regular Tampax Tampon and will be instructed to insert and then remove it. After, they will be asked to record the degree of pain during the entire insertion/removal experience in a 11-point numerical rating scale (NRS) with anchors of 0 (no pain at all) to 10 (worst pain imaginable).

  3 weeks (during the intervention)

• Pain rating during the tampon test

  The participants will be provided with Original Regular Tampax Tampon and will be instructed to insert and then remove it. After, they will be asked to record the degree of pain during the entire insertion/removal experience in a 11-point numerical rating scale (NRS) with anchors of 0 (no pain at all) to 10 (worst pain imaginable).

  12 weeks (immediately after the intervention)

• Pain rating during the tampon test

  The participants will be provided with Original Regular Tampax Tampon and will be instructed to insert and then remove it. After, they will be asked to record the degree of pain during the entire insertion/removal experience in a 11-point numerical rating scale (NRS) with anchors of 0 (no pain at all) to 10 (worst pain imaginable)..

  12 weeks later (if funding becomes available)

• Pressure pain threshold (PPT) at the posterior vaginal fourchette

  PPT will be determined using a custom vulvalgesiometer and will be defined as the average pressure at which women first report pain when the cotton swab tip is applied at 6 o' clock position of the vaginal introitus. The vulvalgesiometer will also be used to evaluate TS of pain when the pressure measured before will be applied ten times at a rate of approximately one per second at the same location on the vestibule. Participants will rate their pain level on the initial and final application of this pressure using the same numeric rating scale (0-10).

  Baseline

• Pressure pain threshold (PPT) at the posterior vaginal fourchette

  PPT will be determined using a custom vulvalgesiometer and will be defined as the average pressure at which women first report pain when the cotton swab tip is applied at 6 o' clock position of the vaginal introitus. The vulvalgesiometer will also be used to evaluate TS of pain when the pressure measured before will be applied ten times at a rate of approximately one per second at the same location on the vestibule. Participants will rate their pain level on the initial and final application of this pressure using the same numeric rating scale (0-10).

  3 weeks (during the intervention)

• Pressure pain threshold (PPT) at the posterior vaginal fourchette

  PPT will be determined using a custom vulvalgesiometer and will be defined as the average pressure at which women first report pain when the cotton swab tip is applied at 6 o' clock position of the vaginal introitus. The vulvalgesiometer will also be used to evaluate TS of pain when the pressure measured before will be applied ten times at a rate of approximately one per second at the same location on the vestibule. Participants will rate their pain level on the initial and final application of this pressure using the same numeric rating scale (0-10).

  12 weeks (following intervention)

• Pressure pain threshold (PPT) at the posterior vaginal fourchette

  PPT will be determined using a custom vulvalgesiometer and will be defined as the average pressure at which women first report pain when the cotton swab tip is applied at 6 o' clock position of the vaginal introitus. The vulvalgesiometer will also be used to evaluate TS of pain when the pressure measured before will be applied ten times at a rate of approximately one per second at the same location on the vestibule. Participants will rate their pain level on the initial and final application of this pressure using the same numeric rating scale (0-10).

  12 weeks after intervention (if funding becomes available)

• Temporal summation of pain

  Difference between pain reported on first application of pressure at the vulvar vestibule, delivered through a vulvalgesiometer, and the pain reported after the tenth application of that same pressure

  Baseline

• Temporal summation of pain

  Difference between pain reported on first application of pressure at the vulvar vestibule, delivered through a vulvalgesiometer, and the pain reported after the tenth application of that same pressure

  3 weeks (during the intervention)

• Temporal summation of pain

  Difference between pain reported on first application of pressure at the vulvar vestibule, delivered through a vulvalgesiometer, and the pain reported after the tenth application of that same pressure

  12 weeks (after the intervention)

• Temporal summation of pain

  Difference between pain reported on first application of pressure at the vulvar vestibule, delivered through a vulvalgesiometer, and the pain reported after the tenth application of that same pressure

  12 weeks later (if funding becomes available)

Secondary Outcomes (26)

• Global Patient satisfaction with treatment

  3 weeks (during intervention)

• Global Patient satisfaction with treatment

  12 weeks (following intervention)

• Global Patient satisfaction with treatment

  12 weeks after intervention (if funding becomes available)

• Female Sexual Function Index (FSFI)

  Baseline

• Female Sexual Function Index (FSFI)

  12 weeks (following intervention)

Other Outcomes (16)

• Tonic activation of the pelvic floor muscles (PFMs)

  Baseline

• Tonic activation of the pelvic floor muscles (PFMs)

  12 weeks (after intervention)

• Tonic activation of the pelvic floor muscles (PFMs)

  12 weeks later (if funding becomes available)

Study Arms (2)

Low Level Laser Therapy Group

EXPERIMENTAL

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.

Other: Low Level Laser Therapy

Sham Low Level Laser Therapy Group

SHAM COMPARATOR

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.

Other: Sham Low Level Laser Therapy

Interventions

Low Level Laser Therapy OTHER

Each stage will follow this sequence of applications: (1) spine application (DUO-240 red and infrared array in a horizontal placement and 2 oblique placements bilaterally + LDR-100 laser probe + LDI-200 laser probe), (2) perineum application (DUO-240 red and infrared array in the surface of the perineum + LDR-100 probe) and (3) overlying branches of the pudendal nerve at the lateral perineum (LDI-200 probe). Parameters of frequency and duty cycle will be increased along with intensity as the stages progress.

Also known as: photobiomodulation

Low Level Laser Therapy Group

Sham Low Level Laser Therapy OTHER

Each stage will follow this sequence of applications: (1) spine application (DUO-240 red and infrared array in a horizontal placement and 2 oblique placements bilaterally + LDR-100 laser probe + LDI-200 laser probe), (2) perineum application (DUO-240 red and infrared array in the surface of the perineum + LDR-100 probe) and (3) overlying branches of the pudendal nerve at the lateral perineum (LDI-200 probe). Parameters of frequency and duty cycle will be progressed, but power will always be set to 1%..

Sham Low Level Laser Therapy Group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Biologically born female older than eighteen years
• Premenopausal
• Not currently pregnant or pregnancy in the past six months
• No metal or electronic implants near neck or head
• No neurological condition such as stroke, multiple sclerosis, spinal cord injury, epilepsy or history of epilepsy in the family
• No tendency to faint
• Signs and symptoms consistent with provoked vestibulodynia alone or provoked vestibulodynia plus vaginismus

You may not qualify if:

• gynaecologist cannot insert a single digit intravaginally and thus the participant would be unlikely able to tolerate the assessment procedures
• other evidence of conditions that may cause vulvar pain such as active lichen sclerosis, fissures, or infection

Sponsors & Collaborators

• University of Ottawa: lead
• BioFlexTM Laser Therapy: collaborator

Study Sites (1)

McLean Function Measurement Lab

Ottawa, Ontario, K1S 1S2, Canada

Location

Related Publications (28)

• Harlow BL, Stewart EG. A population-based assessment of chronic unexplained vulvar pain: have we underestimated the prevalence of vulvodynia? J Am Med Womens Assoc (1972). 2003 Spring;58(2):82-8.

  PMID: 12744420 BACKGROUND

• Spoelstra SK, Dijkstra JR, van Driel MF, Weijmar Schultz WC. Long-term results of an individualized, multifaceted, and multidisciplinary therapeutic approach to provoked vestibulodynia. J Sex Med. 2011 Feb;8(2):489-96. doi: 10.1111/j.1743-6109.2010.01941.x.

  PMID: 20646179 BACKGROUND

• Vallinga MS, Spoelstra SK, Hemel IL, van de Wiel HB, Weijmar Schultz WC. Transcutaneous electrical nerve stimulation as an additional treatment for women suffering from therapy-resistant provoked vestibulodynia: a feasibility study. J Sex Med. 2015 Jan;12(1):228-37. doi: 10.1111/jsm.12740. Epub 2014 Nov 12.

  PMID: 25388372 BACKGROUND

• Goldstein AT, Pukall CF, Brown C, Bergeron S, Stein A, Kellogg-Spadt S. Vulvodynia: Assessment and Treatment. J Sex Med. 2016 Apr;13(4):572-90. doi: 10.1016/j.jsxm.2016.01.020. Epub 2016 Mar 25.

  PMID: 27045258 BACKGROUND

• Migliario M, Sabbatini M, Mortellaro C, Reno F. Near infrared low-level laser therapy and cell proliferation: The emerging role of redox sensitive signal transduction pathways. J Biophotonics. 2018 Nov;11(11):e201800025. doi: 10.1002/jbio.201800025. Epub 2018 Aug 16.

  PMID: 29722183 BACKGROUND

• Passarella S. He-Ne laser irradiation of isolated mitochondria. J Photochem Photobiol B. 1989 Aug;3(4):642-3. doi: 10.1016/1011-1344(89)80090-9. No abstract available.

  PMID: 2507765 BACKGROUND

• Ailioaie C, Lupusoru-Ailioaie LM. Beneficial effects of laser therapy in the early stages of rheumatoid arthritis onset. Laser Ther 11(2):79-87, 1999.

  BACKGROUND

• Foster DC, Beth Kotok M, Huang LS, Watts A, Oakes D, Howard FM, Stodgell CJ, Dworkin RH. The tampon test for vulvodynia treatment outcomes research: reliability, construct validity, and responsiveness. Obstet Gynecol. 2009 Apr;113(4):825-832. doi: 10.1097/AOG.0b013e31819bda7c.

  PMID: 19305326 BACKGROUND

• Pukall CF, Young RA, Roberts MJ, Sutton KS, Smith KB. The vulvalgesiometer as a device to measure genital pressure-pain threshold. Physiol Meas. 2007 Dec;28(12):1543-50. doi: 10.1088/0967-3334/28/12/008. Epub 2007 Dec 3.

  PMID: 18057518 BACKGROUND

• McLean L, Brooks K. What Does Electromyography Tell Us About Dyspareunia? Sex Med Rev. 2017 Jul;5(3):282-294. doi: 10.1016/j.sxmr.2017.02.001. Epub 2017 Mar 18.

  PMID: 28330675 BACKGROUND

• Brostrom S. Motor evoked potentials from the pelvic floor. Neurourol Urodyn. 2003;22(7):620-37. doi: 10.1002/nau.10151.

  PMID: 14595605 BACKGROUND

• Melzack R. The McGill Pain Questionnaire: major properties and scoring methods. Pain. 1975 Sep;1(3):277-299. doi: 10.1016/0304-3959(75)90044-5.

  PMID: 1235985 BACKGROUND

• Rosen R, Brown C, Heiman J, Leiblum S, Meston C, Shabsigh R, Ferguson D, D'Agostino R Jr. The Female Sexual Function Index (FSFI): a multidimensional self-report instrument for the assessment of female sexual function. J Sex Marital Ther. 2000 Apr-Jun;26(2):191-208. doi: 10.1080/009262300278597.

  PMID: 10782451 BACKGROUND

• Meyer-Bahlburg HF, Dolezal C. The female sexual function index: a methodological critique and suggestions for improvement. J Sex Marital Ther. 2007 May-Jun;33(3):217-24. doi: 10.1080/00926230701267852.

  PMID: 17454519 BACKGROUND

• Sullivan MJL, et al. The Pain Catastrophizing Scale: Development and validation. Psychological Assessment 7, 524-532, 1995.

  BACKGROUND

• Lovibond PF, Lovibond SH. The structure of negative emotional states: comparison of the Depression Anxiety Stress Scales (DASS) with the Beck Depression and Anxiety Inventories. Behav Res Ther. 1995 Mar;33(3):335-43. doi: 10.1016/0005-7967(94)00075-u.

  PMID: 7726811 BACKGROUND

• Antony, Martin & Bieling, Peter & Cox, Brian & Enns, Murray & Swinson, Richard. (1998). Psychometric properties of the 42-item and 21-item versions of the Depression Anxiety Stress Scales in clinical groups and a community sample. Psychological Assessment. 10. 176-181. 10.1037/1040-3590.10.2.176.

  BACKGROUND

• Mayer TG, Neblett R, Cohen H, Howard KJ, Choi YH, Williams MJ, Perez Y, Gatchel RJ. The development and psychometric validation of the central sensitization inventory. Pain Pract. 2012 Apr;12(4):276-85. doi: 10.1111/j.1533-2500.2011.00493.x. Epub 2011 Sep 27.

  PMID: 21951710 BACKGROUND

• Burgio KL, Goode PS, Richter HE, Locher JL, Roth DL. Global ratings of patient satisfaction and perceptions of improvement with treatment for urinary incontinence: validation of three global patient ratings. Neurourol Urodyn. 2006;25(5):411-7. doi: 10.1002/nau.20243.

  PMID: 16652380 BACKGROUND

• Pukall, C.F., Cahill, C.M. New Developments in the Pathophysiology of Genital Pain: Role of Central Sensitization. Curr Sex Health Rep 6, 11-19 (2014) doi:10.1007/s11930-013-0007-1.

  BACKGROUND

• Reissing ED, Brown C, Lord MJ, Binik YM, Khalife S. Pelvic floor muscle functioning in women with vulvar vestibulitis syndrome. J Psychosom Obstet Gynaecol. 2005 Jun;26(2):107-13. doi: 10.1080/01443610400023106.

  PMID: 16050536 BACKGROUND

• Gentilcore-Saulnier E, McLean L, Goldfinger C, Pukall CF, Chamberlain S. Pelvic floor muscle assessment outcomes in women with and without provoked vestibulodynia and the impact of a physical therapy program. J Sex Med. 2010 Feb;7(2 Pt 2):1003-22. doi: 10.1111/j.1743-6109.2009.01642.x. Epub 2010 Jan 6.

  PMID: 20059663 BACKGROUND

• Morin M, et al. Dynamometric assessment of the pelvic floor muscle function in women with and without provoked vestibulodynia. Int Urogynecol J 2010: 21: S336-S37

  BACKGROUND

• Morin M, Bergeron S, Khalife S, Mayrand MH, Binik YM. Morphometry of the pelvic floor muscles in women with and without provoked vestibulodynia using 4D ultrasound. J Sex Med. 2014 Mar;11(3):776-85. doi: 10.1111/jsm.12367. Epub 2013 Nov 6.

  PMID: 24344835 BACKGROUND

• McLean L, Thibault-Gagnon S, Brooks K, Goldfinger C, Pukall C, Chamberlain S. Differences in Pelvic Morphology Between Women With and Without Provoked Vestibulodynia. J Sex Med. 2016 Jun;13(6):963-71. doi: 10.1016/j.jsxm.2016.04.066.

  PMID: 27215690 BACKGROUND

• Dargie EE, Chamberlain SM, Pukall CF. Provoked Vestibulodynia: Diagnosis, Self-Reported Pain, and Presentation During Gynaecological Examinations. J Obstet Gynaecol Can. 2017 Mar;39(3):145-151. doi: 10.1016/j.jogc.2017.01.001.

  PMID: 28343555 BACKGROUND

• Lev-Sagie A, Kopitman A, Brzezinski A. Low-Level Laser Therapy for the Treatment of Provoked Vestibulodynia-A Randomized, Placebo-Controlled Pilot Trial. J Sex Med. 2017 Nov;14(11):1403-1411. doi: 10.1016/j.jsxm.2017.09.004. Epub 2017 Sep 29.

  PMID: 28970071 BACKGROUND

• I Antonio F, Pukall C, McLean L. Photobiomodulation therapy for the treatment of vulvar pain among those with provoked vestibulodynia: a randomized controlled trial. J Sex Med. 2025 Apr 15;22(4):579-587. doi: 10.1093/jsxmed/qdaf011.

  PMID: 39940084 DERIVED

MeSH Terms

Conditions

Vulvodynia

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Vulvar Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Study Officials

• Linda McLean

  University of Ottawa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor in the School of Rehabilitation Sciences at the University of Ottawa.

Study Record Dates

• First Submitted: January 9, 2020
• First Posted: January 21, 2020
• Study Start: February 18, 2021
• Primary Completion: January 15, 2023
• Study Completion: March 15, 2023
• Last Updated: April 4, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will be available for 10 years after the publication of the study results.
• Access Criteria: Planned use of data for systematic review or meta-analysis.

Locations

CA (1)