Multidisciplinary Treatment of Chronic Vulvar Pain
- Conditions
- Chronic PainVulvodynia
- Interventions
- Combination Product: Treatment as usualCombination Product: Multidisciplinary treatment
- Registration Number
- NCT03640624
- Lead Sponsor
- Norwegian University of Science and Technology
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- Female
- Target Recruitment
- 106
- Women aged 18 years and older
- Chronic vulvar pain for ≥3 months of duration
- Insufficient Norwegian skills
- Intellectual disability or severe mental disorder
- Severe comorbidity making tailored care necessary (such as active cancer treatment)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control Treatment as usual Treatment as usual Intervention Multidisciplinary treatment Multidisciplinary treatment
- Primary Outcome Measures
Name Time Method Pain intensity with Brief pain inventory (BPI) Baseline, 3 months and 6 months (change) 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)
- Secondary Outcome Measures
Name Time Method Pain intensity with Brief pain inventory (BPI) Baseline, 3 months, 6 months and 12 months (change) 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)
Pain intensity with tampon test Baseline, 6 months and 12 months (change) Intensity of pain with tampon insertion and removal (tampon test) measured on a 0-10 numerical rating scale (0 minimum and 10 maximum pain)
Vulvar pressure pain threshold with vulvalgesiometer Baseline, 6 months and 12 months (change) Vulvar pressure pain threshold in Newton measured with a cotton tipped vulvalgesiometer
Pain intensity with Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2) Baseline, 6 months and 12 months (change) 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.
Sexual distress with Female Sexual Distress Scale - revised (FSDS) Baseline, 6 months and 12 months (change) Sexual distress measured with a 13-item Likert scale-based (0-4) questionnaire (FSDS). Mean score.
Affective symptoms with Hospital Anxiety and Depression Scale (HADS) Baseline, 6 months and 12 months (change) Affective symptoms measured with a 14-item Likert scale-based (0-3) questionnaire (HADS). Both total and subscale (depression and anxiety) scores.
Illness perception with Brief Illness Perception Questionnaire (BIPQ) Baseline, 6 months and 12 months (change) Illness perception measured with a 8-Item NRS-based (0-10) questionnaire. Mean score of total scale.
Pain catastrophizing with Pain Catastrophizing Scale (PCS) Baseline, 6 months and 12 months (change) Pain catastrophizing measured with a 13-Item Likert scale-based (0-4) questionnaire (PCS). Total score.
Levator hiatal area Baseline, 6 months and 12 months (change) Ultrasound-measured difference in levator hiatal area (cm\^2) between rest and contraction and between rest and valsalva maneuver
Trial Locations
- Locations (1)
Cecilie Hagemann
🇳🇴Trondheim, Norway