Multidisciplinary Treatment of Chronic Vulvar Pain

Study Overview
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Brief Summary
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Vulvodynia (i.e. chronic vulvar pain without identifiable cause) is a heterogeneous clinical entity with a complex multifactorial causation. It is long lasting and difficult to treat, and the general consensus of current guidelines states that patients with vulvodynia benefit from a compound multidisciplinary intervention targeting mucosal hypersensitivity, pelvic muscle floor dysfunction and general pain management. However, there is little empiric evidence to support this recommendation. This will be a randomized controlled trial comparing multidisciplinary treatment with standard care for women with vulvodynia.

Detailed Description
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Patients with chronic vulvar pain constitute a heterogeneous group with regards to causes and moderators of pain. Multidisciplinary teams simultaneously assess contributing factors such as infections and dermatoses and treat known mediators of pain, namely mucosal hypersensitivity, pelvic muscle floor dysfunction and general pain management. Treatment as usual, on the other hand, is primarily based on a sequential model applying one type of treatment at a time. The investigator's aim is to compare multidisciplinary treatment including multimodal physiotherapy (intervention group) with standard treatment (control group) in reducing pain, sexual dysfunction and related symptoms in women with vulvodynia. The study sample will be allocated randomly 1:1 to multidisciplinary treatment by a vulva team or to standard treatment by a specialist in gynaecology. The intervention will include a joint consultation by a gynaecologist and a dermatologist, tailored multimodal physiotherapy by a physiotherapist and guided imagery (mindfulness and relaxation) by use of a sound track during home sessions. The controls will receive standard care by a gynaecologist, who is free to offer any kind of non-standardized treatment. Treatment effect will be measured at 3 months and at 6-12 months after inclusion.

Official Title
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Multidisciplinary Treatment of Chronic Vulvar Pain - a Randomized Controlled Study

Conditions
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Vulvodynia, Chronic Pain

Intervention / Treatment
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* Combination Product: Multidisciplinary treatment
* Combination Product: Treatment as usual


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women aged 18 years and older Chronic vulvar pain for ≥3 months of duration Exclusion Criteria: Insufficient Norwegian skills Intellectual disability or severe mental disorder Severe comorbidity making tailored care necessary (such as active cancer treatment)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Multidisciplinary treatment | Combination Product: Multidisciplinary treatment<br>* Assessment by gynaecologist and dermatologist, resulting in tailored vulvar care, including daily topical lidocaine 5% ointment. Other topical or oral medication, such as oestradiol cream or oral antidepressants will be prescribed on individual basis. Tailored physiotherapy targeting muscular dysfunction, utilizing: Patient education, pelvic floor muscle exercises (contraction and relaxation), EMG-biofeedback. Low frequent electrical stimulation, massage, stretching and myofascial release and trigger point treatment of the pelvic floor. Desensitization exercises (manually or vaginal dilator). Relaxation and body awareness. Minimum one visit per month. Guided imagery sessions, minimum twice a week using a sound track that is developed for vulvodynia patients.<br>|
| Active Comparator: Control<br>Treatment as usual | Combination Product: Treatment as usual<br>* Treatment as usual in accordance with local guidelines by specialist in gynaecology, including a minimum of two visits (when diagnosis is made and after 3 - 6 months)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain intensity with Brief pain inventory (BPI) | Intensity of pain measured with BPI using the mean of the 4 subscales (current, averaged, maximum and minimum pain during the last week) on a 0-10 numerical rating scale (0 minimum and 10 maximum pain) | Baseline, 3 months and 6 months (change) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain intensity with Brief pain inventory (BPI) | Intensity of pain measured with BPI using the mean of the 4 subscales (current, averaged, maximum and minimum pain during the last week) on a 0-10 numerical rating scale (0 minimum and 10 maximum pain) | Baseline, 3 months, 6 months and 12 months (change) | 
| Pain intensity with tampon test | Intensity of pain with tampon insertion and removal (tampon test) measured on a 0-10 numerical rating scale (0 minimum and 10 maximum pain) | Baseline and 6 months (change) | 
| Pain intensity with tampon test | Intensity of pain with tampon insertion and removal (tampon test) measured on a 0-10 numerical rating scale (0 minimum and 10 maximum pain) | Baseline, 6 months and 12 months (change) | 
| Vulvar pressure pain threshold with vulvalgesiometer | Vulvar pressure pain threshold in Newton measured with a cotton tipped vulvalgesiometer | Baseline and 6 months (change) | 
| Vulvar pressure pain threshold with vulvalgesiometer | Vulvar pressure pain threshold in Newton measured with a cotton tipped vulvalgesiometer | Baseline, 6 months and 12 months (change) | 
| Pain intensity with Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2) | Pain intensity measured by a 22-Item NRS-based (0-10) questionnaire (SF-MPQ-2). Both total and subscale (continuous, intermittent, neuropathic, and affective pain) mean scores. | Baseline and 6 months (change) | 
| Pain intensity with Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2) | Pain intensity measured by a 22-Item NRS-based (0-10) questionnaire (SF-MPQ-2). Both total and subscale (continuous, intermittent, neuropathic, and affective pain) mean scores. | Baseline, 6 months and 12 months (change) | 
| Sexual distress with Female Sexual Distress Scale - revised (FSDS) | Sexual distress measured with a 13-item Likert scale-based (0-4) questionnaire (FSDS). Mean score. | Baseline and 6 months (change) | 
| Sexual distress with Female Sexual Distress Scale - revised (FSDS) | Sexual distress measured with a 13-item Likert scale-based (0-4) questionnaire (FSDS). Mean score. | Baseline, 6 months and 12 months (change) | 
| Affective symptoms with Hospital Anxiety and Depression Scale (HADS) | Affective symptoms measured with a 14-item Likert scale-based (0-3) questionnaire (HADS). Both total and subscale (depression and anxiety) scores. | Baseline and 6 months (change) | 
| Affective symptoms with Hospital Anxiety and Depression Scale (HADS) | Affective symptoms measured with a 14-item Likert scale-based (0-3) questionnaire (HADS). Both total and subscale (depression and anxiety) scores. | Baseline, 6 months and 12 months (change) | 
| Illness perception with Brief Illness Perception Questionnaire (BIPQ) | Illness perception measured with a 8-Item NRS-based (0-10) questionnaire. Mean score of total scale. | Baseline and 6 months (change) | 
| Illness perception with Brief Illness Perception Questionnaire (BIPQ) | Illness perception measured with a 8-Item NRS-based (0-10) questionnaire. Mean score of total scale. | Baseline, 6 months and 12 months (change) | 
| Pain catastrophizing with Pain Catastrophizing Scale (PCS) | Pain catastrophizing measured with a 13-Item Likert scale-based (0-4) questionnaire (PCS). Total score. | Baseline and 6 months (change) | 
| Pain catastrophizing with Pain Catastrophizing Scale (PCS) | Pain catastrophizing measured with a 13-Item Likert scale-based (0-4) questionnaire (PCS). Total score. | Baseline, 6 months and 12 months (change) | 
| Levator hiatal area | Ultrasound-measured difference in levator hiatal area (cm^2) between rest and contraction and between rest and valsalva maneuver | Baseline and 6 months (change) | 
| Levator hiatal area | Ultrasound-measured difference in levator hiatal area (cm^2) between rest and contraction and between rest and valsalva maneuver | Baseline, 6 months and 12 months (change) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Physical Therapy Modalities