Multidisciplinary Treatment of Chronic Vulvar Pain

NCT03640624 | Active Not Recruiting

• 1 other identifier: 2016/2150
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

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.

Conditions

Vulvodynia; Chronic Pain

Keywords

Physical Therapy Modalities

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (17)

• Pain intensity with Brief pain inventory (BPI)

  Baseline, 3 months, 6 months and 12 months (change)

• Pain intensity with tampon test

  Baseline and 6 months (change)

• Pain intensity with tampon test

  Baseline, 6 months and 12 months (change)

• Vulvar pressure pain threshold with vulvalgesiometer

  Baseline and 6 months (change)

• Vulvar pressure pain threshold with vulvalgesiometer

  Baseline, 6 months and 12 months (change)

Study Arms (2)

Intervention

EXPERIMENTAL

Multidisciplinary treatment

Combination Product: Multidisciplinary treatment

Control

ACTIVE COMPARATOR

Treatment as usual

Combination Product: Treatment as usual

Interventions

Multidisciplinary treatment COMBINATION_PRODUCT

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.

Intervention

Treatment as usual COMBINATION_PRODUCT

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)

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women aged 18 years and older
• Chronic vulvar pain for ≥3 months of duration

You may not qualify if:

• Insufficient Norwegian skills
• Intellectual disability or severe mental disorder
• Severe comorbidity making tailored care necessary (such as active cancer treatment)

Sponsors & Collaborators

• Norwegian University of Science and Technology: lead
• St. Olavs Hospital: collaborator

Study Sites (1)

Cecilie Hagemann

Trondheim, 7006, Norway

Location

MeSH Terms

Conditions

Vulvodynia; Chronic Pain

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Vulvar Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Berit Schei, prof

  Norwegian University of Science and Technology

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2018
• First Posted: August 21, 2018
• Study Start: September 18, 2018
• Primary Completion: November 10, 2024
• Study Completion (Estimated): June 1, 2027
• Last Updated: December 12, 2025

Record last verified: 2025-12

Locations

NO (1)