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Active, Not Recruiting

NCT Number: NCT03640624

Multidisciplinary Treatment of Chronic Vulvar Pain

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

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

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Cecilie Hagemann

Trondheim, 7006, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Multidisciplinary treatment

Combination Product
  • 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.
  • 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.
  • Guided imagery sessions, minimum twice a week using a sound track that is developed for vulvodynia patients.

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)

Primary outcomes

  1. Pain intensity with Brief pain inventory (BPI)

    Time frame: 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 outcomes

  1. Pain intensity with Brief pain inventory (BPI)

    Time frame: 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)

  2. Pain intensity with tampon test

    Time frame: Baseline and 6 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)

  3. Pain intensity with tampon test

    Time frame: 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)

  4. Vulvar pressure pain threshold with vulvalgesiometer

    Time frame: Baseline and 6 months (change)

    Vulvar pressure pain threshold in Newton measured with a cotton tipped vulvalgesiometer

  5. Vulvar pressure pain threshold with vulvalgesiometer

    Time frame: Baseline, 6 months and 12 months (change)

    Vulvar pressure pain threshold in Newton measured with a cotton tipped vulvalgesiometer

  6. Pain intensity with Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2)

    Time frame: Baseline and 6 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.

  7. Pain intensity with Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2)

    Time frame: 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.

  8. Sexual distress with Female Sexual Distress Scale - revised (FSDS)

    Time frame: Baseline and 6 months (change)

    Sexual distress measured with a 13-item Likert scale-based (0-4) questionnaire (FSDS). Mean score.

  9. Sexual distress with Female Sexual Distress Scale - revised (FSDS)

    Time frame: Baseline, 6 months and 12 months (change)

    Sexual distress measured with a 13-item Likert scale-based (0-4) questionnaire (FSDS). Mean score.

  10. Affective symptoms with Hospital Anxiety and Depression Scale (HADS)

    Time frame: Baseline and 6 months (change)

    Affective symptoms measured with a 14-item Likert scale-based (0-3) questionnaire (HADS). Both total and subscale (depression and anxiety) scores.

  11. Affective symptoms with Hospital Anxiety and Depression Scale (HADS)

    Time frame: 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.

  12. Illness perception with Brief Illness Perception Questionnaire (BIPQ)

    Time frame: Baseline and 6 months (change)

    Illness perception measured with a 8-Item NRS-based (0-10) questionnaire. Mean score of total scale.

  13. Illness perception with Brief Illness Perception Questionnaire (BIPQ)

    Time frame: Baseline, 6 months and 12 months (change)

    Illness perception measured with a 8-Item NRS-based (0-10) questionnaire. Mean score of total scale.

  14. Pain catastrophizing with Pain Catastrophizing Scale (PCS)

    Time frame: Baseline and 6 months (change)

    Pain catastrophizing measured with a 13-Item Likert scale-based (0-4) questionnaire (PCS). Total score.

  15. Pain catastrophizing with Pain Catastrophizing Scale (PCS)

    Time frame: Baseline, 6 months and 12 months (change)

    Pain catastrophizing measured with a 13-Item Likert scale-based (0-4) questionnaire (PCS). Total score.

  16. Levator hiatal area

    Time frame: Baseline and 6 months (change)

    Ultrasound-measured difference in levator hiatal area (cm^2) between rest and contraction and between rest and valsalva maneuver

  17. Levator hiatal area

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Norwegian University of Science and Technology

Other

Collaborators

  • St. Olavs Hospital

Registry information

Official study title

Multidisciplinary Treatment of Chronic Vulvar Pain - a Randomized Controlled Study

Important dates

Study start
2018
Primary completion
2024
Study completion
2027
First posted
Aug 21, 2018
Registry last updated
Dec 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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