Provoked Vestibulodynia Clinical Trial
Official title:
Is Low Level Laser Therapy (LLLT) Effective for Reducing Pain Experienced by Women With Provoked Vestibulodynia?
Verified date | March 2023 |
Source | University of Ottawa |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 28 |
Est. completion date | March 15, 2023 |
Est. primary completion date | January 15, 2023 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria - 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 Exclusion Criteria - 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 |
Country | Name | City | State |
---|---|---|---|
Canada | McLean Function Measurement Lab | Ottawa | Ontario |
Lead Sponsor | Collaborator |
---|---|
University of Ottawa | BioFlexTM Laser Therapy |
Canada,
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* Note: There are 27 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Tonic activation of the pelvic floor muscles (PFMs) | Mean smoothed, rectified activation amplitude of the PFMs recorded through electromyography while the muscles remain at rest. | Baseline | |
Other | Tonic activation of the pelvic floor muscles (PFMs) | Mean smoothed, rectified activation amplitude of the PFMs recorded through electromyography while the muscles remain at rest. | 12 weeks (after intervention) | |
Other | Tonic activation of the pelvic floor muscles (PFMs) | Mean smoothed, rectified activation amplitude of the PFMs recorded through electromyography while the muscles remain at rest. | 12 weeks later (if funding becomes available) | |
Other | Maximum voluntary activation of the pelvic floor muscles (PFMs) | Mean smoothed, rectified activation amplitude of the PFMs recorded through electromyography while participants attempt a maximum voluntary activation of their PFMs | Baseline | |
Other | Maximum voluntary activation of the pelvic floor muscles (PFMs) | Mean smoothed, rectified activation amplitude of the PFMs recorded through electromyography while participants attempt a maximum voluntary activation of their PFMs | 12 weeks (after intervention) | |
Other | Maximum voluntary activation of the pelvic floor muscles (PFMs) | Mean smoothed, rectified activation amplitude of the PFMs recorded through electromyography while participants attempt a maximum voluntary activation of their PFMs | 12 weeks later (if funding becomes available) | |
Other | Activation of the pelvic floor muscles (PFMs) during a bearing down maneuver | Mean smoothed, rectified activation amplitude of the PFMs recorded through electromyography while participants perform a bearing down maneuver | Baseline | |
Other | Activation of the pelvic floor muscles (PFMs) during a bearing down maneuver | Mean smoothed, rectified activation amplitude of the PFMs recorded through electromyography while participants perform a bearing down maneuver | 12 weeks (after intervention) | |
Other | Activation of the pelvic floor muscles (PFMs) during a bearing down maneuver | Mean smoothed, rectified activation amplitude of the PFMs recorded through electromyography while participants perform a bearing down maneuver | 12 weeks later (if funding becomes available) | |
Other | Anticipatory responses (ms) to pressure applied at the vulvar vestibule | The proportion of women in each group who demonstrate anticipatory responses of the PFMs to impeding pressure applied at the vulvar vestibule will be determined for each group. Participants will be deemed to have anticipatory responses if electromyiographic signals recorded from the PFMs precede the application of pressure. A vulvagesiometer will be employed using a response-dependent methodology. The vulvagesiometer will be used to apply low (25g) and moderate (232g) pressure to the posterior vaginal fourchette or to the posterior thigh. | Baseline | |
Other | Anticipatory responses (ms) to pressure applied at the vulvar vestibule | The proportion of women in each group who demonstrate anticipatory responses of the PFMs to impeding pressure applied at the vulvar vestibule will be determined for each group. Participants will be deemed to have anticipatory responses if electromyiographic signals recorded from the PFMs precede the application of pressure. A vulvagesiometer will be employed using a response-dependent methodology. The vulvagesiometer will be used to apply low (25g) and moderate (232g) pressure to the posterior vaginal fourchette or to the posterior thigh. | 12 weeks (after the intervention) | |
Other | Anticipatory responses (ms) to pressure applied at the vulvar vestibule | The proportion of women in each group who demonstrate anticipatory responses of the PFMs to impeding pressure applied at the vulvar vestibule will be determined for each group. Participants will be deemed to have anticipatory responses if electromyiographic signals recorded from the PFMs precede the application of pressure. A vulvagesiometer will be employed using a response-dependent methodology. The vulvagesiometer will be used to apply low (25g) and moderate (232g) pressure to the posterior vaginal fourchette or to the posterior thigh. | 12 weeks later (if funding becomes available) | |
Other | Behavioural responses (µV) to pressure applied at the vulvar vestibule | The proportion of women in each group who demonstrate behavioural responses of the PFMs to pressure applied at the vulvar vestibule will be determined for each group. Participants will be deemed to have behavioural responses if the activation of the PFMs (or other muscles) occurs after the pressure is applied. A vulvagesiometer will be employed using a response-dependent methodology. The vulvagesiometer will be used to apply low (25g) and moderate (232g) pressure to the posterior vaginal fourchette or to the posterior thigh. | Baseline | |
Other | Behavioural responses (µV) to pressure applied at the vulvar vestibule | The proportion of women in each group who demonstrate behavioural responses of the PFMs to pressure applied at the vulvar vestibule will be determined for each group. Participants will be deemed to have behavioural responses if the activation of the PFMs (or other muscles) occurs after the pressure is applied. A vulvagesiometer will be employed using a response-dependent methodology. The vulvagesiometer will be used to apply low (25g) and moderate (232g) pressure to the posterior vaginal fourchette or to the posterior thigh. | 12 weeks (after the intervention) | |
Other | Behavioural responses (µV) to pressure applied at the vulvar vestibule | The proportion of women in each group who demonstrate behavioural responses of the PFMs to pressure applied at the vulvar vestibule will be determined for each group. Participants will be deemed to have behavioural responses if the activation of the PFMs (or other muscles) occurs after the pressure is applied. A vulvagesiometer will be employed using a response-dependent methodology. The vulvagesiometer will be used to apply low (25g) and moderate (232g) pressure to the posterior vaginal fourchette or to the posterior thigh. | 12 weeks later (if funding becomes available) | |
Other | Adherence to the intervention protocol | Attendance of laser treatment visits will be tracked. | 12 weeks (after the intervention) | |
Primary | 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) | |
Primary | 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) | |
Primary | 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) | |
Primary | 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: Pain severity Emotional response Cognitive response Life interference Sexual function interference 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 | |
Primary | 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: Pain severity Emotional response Cognitive response Life interference Sexual function interference 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) | |
Primary | 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: Pain severity Emotional response Cognitive response Life interference Sexual function interference 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) | |
Primary | 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: Pain severity Emotional response Cognitive response Life interference Sexual function interference 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) | |
Primary | 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 | |
Primary | 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) | |
Primary | 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) | |
Primary | 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) | |
Primary | 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 | |
Primary | 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) | |
Primary | 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) | |
Primary | 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) | |
Primary | 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 | |
Primary | 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) | |
Primary | 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) | |
Primary | 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 | Global Patient satisfaction with treatment | Global patient satisfaction with treatment is a single question through which participants provide a ordinal rating based on their satisfaction with the intervention.
Completely, Somewhat, Not at all. Higher ratings is associated with better outcomes. |
3 weeks (during intervention) | |
Secondary | Global Patient satisfaction with treatment | Global patient satisfaction with treatment is a single question through which participants provide a ordinal rating based on their satisfaction with the intervention.
Completely, Somewhat, Not at all. Higher ratings is associated with better outcomes. |
12 weeks (following intervention) | |
Secondary | Global Patient satisfaction with treatment | Global patient satisfaction with treatment is a single question through which participants provide a ordinal rating based on their satisfaction with the intervention.
Completely, Somewhat, Not at all. Higher ratings is associated with better outcomes. |
12 weeks after intervention (if funding becomes available) | |
Secondary | Female Sexual Function Index (FSFI) | This is a 19-item validated questionnaire for assessing the key dimension of sexual function in women, considered a gold standard for evaluation of sexual function. It assesses six domains: desire, arousal , lubrification, orgasm, satisfaction, and pain. All scores are totaled for a maximum of 36. Higher scores represents better sexual function. A score =26.55 has been set as a cutoff to identify those at risk for sexual dysfunction. | Baseline | |
Secondary | Female Sexual Function Index (FSFI) | This is a 19-item validated questionnaire for assessing the key dimension of sexual function in women, considered a gold standard for evaluation of sexual function. It assesses six domains: desire, arousal , lubrification, orgasm, satisfaction, and pain. All scores are totaled for a maximum of 36. Higher scores represents better sexual function. A score =26.55 has been set as a cutoff to identify those at risk for sexual dysfunction. | 12 weeks (following intervention) | |
Secondary | Female Sexual Function Index (FSFI) | This is a 19-item validated questionnaire for assessing the key dimension of sexual function in women, considered a gold standard for evaluation of sexual function. It assesses six domains: desire, arousal , lubrification, orgasm, satisfaction, and pain. All scores are totaled for a maximum of 36. Higher scores represents better sexual function. A score =26.55 has been set as a cutoff to identify those at risk for sexual dysfunction. | 12 weeks after intervention (if funding becomes available) | |
Secondary | Motor evoked potential (MEP) peak to peak amplitude (µV) | Transcranial magnetic stimulation outcome will be determined for all participants and compared among groups. A Magstim® 200 system coupled with a double coil (96 mm loops, P/N 9902) will be used to probe the corticospinal projections to PFMs. MEPs will be ensemble averaged to generate estimates of MEP peak to peak amplitude (µV). | Baseline | |
Secondary | Motor evoked potential (MEP) peak to peak amplitude (µV) | Transcranial magnetic stimulation outcome will be determined for all participants and compared among groups. A Magstim® 200 system coupled with a double coil (96 mm loops, P/N 9902) will be used to probe the corticospinal projections to PFMs. MEPs will be ensemble averaged to generate estimates of MEP peak to peak amplitude (µV). | 12 weeks (immediately after the intervention) | |
Secondary | Motor evoked potential (MEP) peak to peak amplitude (µV) | Transcranial magnetic stimulation outcome will be determined for all participants and compared among groups. A Magstim® 200 system coupled with a double coil (96 mm loops, P/N 9902) will be used to probe the corticospinal projections to PFMs. MEPs will be ensemble averaged to generate estimates of MEP peak to peak amplitude (µV). | 12 weeks later (if funding becomes available) | |
Secondary | Cortical silent period (ms) | Transcranial magnetic stimulation outcome will be determined for all participants and compared among groups. A Magstim® 200 system coupled with a double coil (96 mm loops, P/N 9902) will be used to probe the corticospinal projections to PFMs. MEP cortical silent period (cSP) will be measured from individual trials and then averaged. | Baseline | |
Secondary | Cortical silent period (ms) | Transcranial magnetic stimulation outcome will be determined for all participants and compared among groups. A Magstim® 200 system coupled with a double coil (96 mm loops, P/N 9902) will be used to probe the corticospinal projections to PFMs. MEP cortical silent period (cSP) will be measured from individual trials and then averaged. | 12 weeks (immediately after the intervention) | |
Secondary | Cortical silent period (ms) | Transcranial magnetic stimulation outcome will be determined for all participants and compared among groups. A Magstim® 200 system coupled with a double coil (96 mm loops, P/N 9902) will be used to probe the corticospinal projections to PFMs. MEP cortical silent period (cSP) will be measured from individual trials and then averaged. | 12 weeks later (if funding becomes available) | |
Secondary | Pain Catastrophizing Scale | This is a reliable and valid scale to measure of catastrophizing. The scores from this questionnaire is predictors of intensity of physical and emotional distress. It is a self-report measure, consisting of 13 items scored from 0 to 4, resulting in a total possible score of 52. The higher the score, the more catastrophizing thoughts are present. | Baseline | |
Secondary | Pain Catastrophizing Scale | This is a reliable and valid scale to measure of catastrophizing. The scores from this questionnaire is predictors of intensity of physical and emotional distress. It is a self-report measure, consisting of 13 items scored from 0 to 4, resulting in a total possible score of 52. The higher the score, the more catastrophizing thoughts are present. | 12 weeks (after the intervention) | |
Secondary | Pain Catastrophizing Scale | This is a reliable and valid scale to measure of catastrophizing. The scores from this questionnaire is predictors of intensity of physical and emotional distress. It is a self-report measure, consisting of 13 items scored from 0 to 4, resulting in a total possible score of 52. The higher the score, the more catastrophizing thoughts are present. | 12 weeks later (if funding becomes available) | |
Secondary | Depression Anxiety Stress Scale (DASS) | This is a 42-item self report instrument designed to measure the three related negative emotional states of depression, anxiety and tension/stress. Each one contains 14 items, divided into subscales of 2-5 items with similar content. The DASS have been shown to have high internal consistency and to yield meaningful discriminations in a variety of settings.
A higher score on the DASS indicates greater severity or frequency of these negative emotional symptoms. The maximum score is 126. |
Baseline | |
Secondary | Depression Anxiety Stress Scale (DASS) | This is a 42-item self report instrument designed to measure the three related negative emotional states of depression, anxiety and tension/stress. Each one contains 14 items, divided into subscales of 2-5 items with similar content. The DASS have been shown to have high internal consistency and to yield meaningful discriminations in a variety of settings.
A higher score on the DASS indicates greater severity or frequency of these negative emotional symptoms. The maximum score is 126. |
3 weeks (during the intervention) | |
Secondary | Depression Anxiety Stress Scale (DASS) | This is a 42-item self report instrument designed to measure the three related negative emotional states of depression, anxiety and tension/stress. Each one contains 14 items, divided into subscales of 2-5 items with similar content. The DASS have been shown to have high internal consistency and to yield meaningful discriminations in a variety of settings.
A higher score on the DASS indicates greater severity or frequency of these negative emotional symptoms. The maximum score is 126. |
12 weeks (after the intervention) | |
Secondary | Depression Anxiety Stress Scale (DASS) | This is a 42-item self report instrument designed to measure the three related negative emotional states of depression, anxiety and tension/stress. Each one contains 14 items, divided into subscales of 2-5 items with similar content. The DASS have been shown to have high internal consistency and to yield meaningful discriminations in a variety of settings.
A higher score on the DASS indicates greater severity or frequency of these negative emotional symptoms. The maximum score is 126. |
12 weeks later (if funding becomes available) | |
Secondary | Central sensitization index | The Central Sensitisation Inventory (CSI) is a self-report outcome measure designed to identify patients who have symptoms that may be related to central sensitisation (CS) or central sensitivity syndromes (CSS). Part A includes 25 questions related to common CSS symptoms.
Part B determines if the patient has been diagnosed with certain CSS disorders or related disorders, such as anxiety and depression. CSI severity levels have been established for part A: subclinical = 0 to 29; mild = 30 to 39; moderate = 40 to 49; severe = 50 to 59; and extreme = 60 to 100. |
Baseline | |
Secondary | Central sensitization index | The Central Sensitisation Inventory (CSI) is a self-report outcome measure designed to identify patients who have symptoms that may be related to central sensitisation (CS) or central sensitivity syndromes (CSS). Part A includes 25 questions related to common CSS symptoms.
Part B determines if the patient has been diagnosed with certain CSS disorders or related disorders, such as anxiety and depression. CSI severity levels have been established for part A: subclinical = 0 to 29; mild = 30 to 39; moderate = 40 to 49; severe = 50 to 59; and extreme = 60 to 100. |
12 weeks (after the intervention) | |
Secondary | Central sensitization index | The Central Sensitisation Inventory (CSI) is a self-report outcome measure designed to identify patients who have symptoms that may be related to central sensitisation (CS) or central sensitivity syndromes (CSS). Part A includes 25 questions related to common CSS symptoms.
Part B determines if the patient has been diagnosed with certain CSS disorders or related disorders, such as anxiety and depression. CSI severity levels have been established for part A: subclinical = 0 to 29; mild = 30 to 39; moderate = 40 to 49; severe = 50 to 59; and extreme = 60 to 100. |
12 weeks later (if funding becomes available) | |
Secondary | The Vulvar Pain Assessment Questionnaire - Supplemental Domains | Supplemental Domains Pain Descriptors (VPAQdesc). This pain descriptor scale contains the most common words used to describe chronic vulvar pain.
Burning/stinging pain Incisive pain Sensitivity Coping Strategies (VPAQcope). This scale addresses some common coping strategies that are utilized by women with vulvar pain. Distraction/relaxation strategies Problem-solving strategies Partner Factors (VPAQpartner). This 24-item scale encompasses how romantic partners/spouses may be impacted by/respond to vulvar pain experienced by one partner. Negative response Support seeking Impact on relationship Sexual communication 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 | |
Secondary | The Vulvar Pain Assessment Questionnaire - Supplemental Domains | Supplemental Domains Pain Descriptors (VPAQdesc). This pain descriptor scale contains the most common words used to describe chronic vulvar pain.
Burning/stinging pain Incisive pain Sensitivity Coping Strategies (VPAQcope). This scale addresses some common coping strategies that are utilized by women with vulvar pain. Distraction/relaxation strategies Problem-solving strategies Partner Factors (VPAQpartner). This 24-item scale encompasses how romantic partners/spouses may be impacted by/respond to vulvar pain experienced by one partner. Negative response Support seeking Impact on relationship Sexual communication 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) | |
Secondary | The Vulvar Pain Assessment Questionnaire - Supplemental Domains | Supplemental Domains Pain Descriptors (VPAQdesc). This pain descriptor scale contains the most common words used to describe chronic vulvar pain.
Burning/stinging pain Incisive pain Sensitivity Coping Strategies (VPAQcope). This scale addresses some common coping strategies that are utilized by women with vulvar pain. Distraction/relaxation strategies Problem-solving strategies Partner Factors (VPAQpartner). This 24-item scale encompasses how romantic partners/spouses may be impacted by/respond to vulvar pain experienced by one partner. Negative response Support seeking Impact on relationship Sexual communication 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) | |
Secondary | The Vulvar Pain Assessment Questionnaire - Supplemental Domains | Supplemental Domains Pain Descriptors (VPAQdesc). This pain descriptor scale contains the most common words used to describe chronic vulvar pain.
Burning/stinging pain Incisive pain Sensitivity Coping Strategies (VPAQcope). This scale addresses some common coping strategies that are utilized by women with vulvar pain. Distraction/relaxation strategies Problem-solving strategies Partner Factors (VPAQpartner). This 24-item scale encompasses how romantic partners/spouses may be impacted by/respond to vulvar pain experienced by one partner. Negative response Support seeking Impact on relationship Sexual communication 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) |
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