Clinical trial NCT03640624: Multidisciplinary Treatment of Chronic Vulvar Pain
Official title: Multidisciplinary Treatment of Chronic Vulvar Pain - a Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Vulvodynia
Chronic Pain
Keywords: Physical Therapy Modalities
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: St. Olavs Hospital
First posted: 2018-08-21
Enrollment: 106
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Pain intensity with Brief pain inventory (BPI)
timeFrame: Baseline, 3 months and 6 months (change)
Secondary outcomes:
measure: Pain intensity with Brief pain inventory (BPI)
timeFrame: Baseline, 3 months, 6 months and 12 months (change)
measure: Pain intensity with tampon test
timeFrame: Baseline and 6 months (change)
measure: Pain intensity with tampon test
timeFrame: Baseline, 6 months and 12 months (change)
measure: Vulvar pressure pain threshold with vulvalgesiometer
timeFrame: Baseline and 6 months (change)
measure: Vulvar pressure pain threshold with vulvalgesiometer
timeFrame: Baseline, 6 months and 12 months (change)
measure: Pain intensity with Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2)
timeFrame: Baseline and 6 months (change)
measure: Pain intensity with Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2)
timeFrame: Baseline, 6 months and 12 months (change)
measure: Sexual distress with Female Sexual Distress Scale - revised (FSDS)
timeFrame: Baseline and 6 months (change)
measure: Sexual distress with Female Sexual Distress Scale - revised (FSDS)
timeFrame: Baseline, 6 months and 12 months (change)
measure: Affective symptoms with Hospital Anxiety and Depression Scale (HADS)
timeFrame: Baseline and 6 months (change)
measure: Affective symptoms with Hospital Anxiety and Depression Scale (HADS)
timeFrame: Baseline, 6 months and 12 months (change)
measure: Illness perception with Brief Illness Perception Questionnaire (BIPQ)
timeFrame: Baseline and 6 months (change)
measure: Illness perception with Brief Illness Perception Questionnaire (BIPQ)
timeFrame: Baseline, 6 months and 12 months (change)
measure: Pain catastrophizing with Pain Catastrophizing Scale (PCS)
timeFrame: Baseline and 6 months (change)
measure: Pain catastrophizing with Pain Catastrophizing Scale (PCS)
timeFrame: Baseline, 6 months and 12 months (change)
measure: Levator hiatal area
timeFrame: Baseline and 6 months (change)
measure: Levator hiatal area
timeFrame: Baseline, 6 months and 12 months (change)
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: Cecilie Hagemann
Study officials:
affiliation: Norwegian University of Science and Technology
name: Berit Schei, prof
role: STUDY_CHAIR
References: