Multidisciplinary Treatment of Chronic Vulvar Pain

Norwegian University of Science and Technology

Status: Active, not recruiting

Conditions: Chronic Pain; Vulvodynia

Treatments: Combination Product: Multidisciplinary treatment; Combination Product: Treatment as usual

Study type: Interventional

Funder types: Other

Identifiers

NCT03640624

2016/2150

Details and patient eligibility

About

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.

Full 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.

Enrollment: 106 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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106 participants in 2 patient groups

Intervention

Experimental group

Description:

Multidisciplinary treatment

Treatment:

Combination Product: Multidisciplinary treatment

Control

Active Comparator group

Description:

Treatment as usual

Treatment:

Combination Product: Treatment as usual