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Clinical trial

Multidisciplinary Treatment of Chronic Vulvar Pain - a Randomized Controlled Study

ID
Name
2016/2150
Description
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.
Trial arms
Trial start
2018-09-18
Estimated PCD
2024-06-01
Trial end
2024-06-01
Status
Recruiting
Treatment
Multidisciplinary treatment
1. 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. 2. 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. 3. Guided imagery sessions, minimum twice a week using a sound track that is developed for vulvodynia patients.
Arms:
Intervention
Treatment as usual
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)
Arms:
Control
Size
110
Primary endpoint
Pain intensity with Brief pain inventory (BPI)
Baseline, 3 months and 6 months (change)
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)
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 110, 'type': 'ESTIMATED'}}
Updated at
2023-12-29

1 organization

2 products

2 indications

Organization
Norwegian University of Science and Technology
Product
Multidisciplinary treatment
Indication
vulvodynia
Indication
Chronic Pain
Product
Treatment as usual