Multidisciplinary Treatment of Chronic Vulvar Pain

Multidisciplinary Treatment of Chronic Vulvar Pain - a Randomized Controlled Study

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Pain; Vulvodynia
• Intervention / Treatment: Combination product: Multidisciplinary treatment; Combination product: Treatment as usual

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.

• Study Type: Interventional
• Enrollment (Estimated): 110
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Cecilie Therese Hagemann; Phone Number: +47 97159869; Email: cecilie.hagemann@ntnu.no
• Study Contact Backup: Name: Ingrid Volløyhaug; Phone Number: 97549124; Email: ingrid.volloyhaug@ntnu.no

Study Locations

• Norway
  • Trondheim, Norway, 7006
    • Recruiting
    • Cecilie Hagemann
    • Contact: Cecilie Therese Hagemann; Phone Number: 95829490; Email: cecilie.hagemann@ntnu.no
    • Contact: Ragnhild Mork Andresen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; Multidisciplinary treatment	Combination product: Multidisciplinary treatment; 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.
Active Comparator: Control; Treatment as usual	Combination product: 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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, 6 months and 12 months (change)
Pain intensity with tampon test	Intensity of pain with tampon insertion and removal (tampon test) measured on a 0-10 numerical rating scale (0 minimum and 10 maximum pain)	Baseline and 6 months (change)
Pain intensity with tampon test	Intensity of pain with tampon insertion and removal (tampon test) measured on a 0-10 numerical rating scale (0 minimum and 10 maximum pain)	Baseline, 6 months and 12 months (change)
Vulvar pressure pain threshold with vulvalgesiometer	Vulvar pressure pain threshold in Newton measured with a cotton tipped vulvalgesiometer	Baseline and 6 months (change)
Vulvar pressure pain threshold with vulvalgesiometer	Vulvar pressure pain threshold in Newton measured with a cotton tipped vulvalgesiometer	Baseline, 6 months and 12 months (change)
Pain intensity with Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2)	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.	Baseline and 6 months (change)
Pain intensity with Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2)	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.	Baseline, 6 months and 12 months (change)
Sexual distress with Female Sexual Distress Scale - revised (FSDS)	Sexual distress measured with a 13-item Likert scale-based (0-4) questionnaire (FSDS). Mean score.	Baseline and 6 months (change)
Sexual distress with Female Sexual Distress Scale - revised (FSDS)	Sexual distress measured with a 13-item Likert scale-based (0-4) questionnaire (FSDS). Mean score.	Baseline, 6 months and 12 months (change)
Affective symptoms with Hospital Anxiety and Depression Scale (HADS)	Affective symptoms measured with a 14-item Likert scale-based (0-3) questionnaire (HADS). Both total and subscale (depression and anxiety) scores.	Baseline and 6 months (change)
Affective symptoms with Hospital Anxiety and Depression Scale (HADS)	Affective symptoms measured with a 14-item Likert scale-based (0-3) questionnaire (HADS). Both total and subscale (depression and anxiety) scores.	Baseline, 6 months and 12 months (change)
Illness perception with Brief Illness Perception Questionnaire (BIPQ)	Illness perception measured with a 8-Item NRS-based (0-10) questionnaire. Mean score of total scale.	Baseline and 6 months (change)
Illness perception with Brief Illness Perception Questionnaire (BIPQ)	Illness perception measured with a 8-Item NRS-based (0-10) questionnaire. Mean score of total scale.	Baseline, 6 months and 12 months (change)
Pain catastrophizing with Pain Catastrophizing Scale (PCS)	Pain catastrophizing measured with a 13-Item Likert scale-based (0-4) questionnaire (PCS). Total score.	Baseline and 6 months (change)
Pain catastrophizing with Pain Catastrophizing Scale (PCS)	Pain catastrophizing measured with a 13-Item Likert scale-based (0-4) questionnaire (PCS). Total score.	Baseline, 6 months and 12 months (change)
Levator hiatal area	Ultrasound-measured difference in levator hiatal area (cm^2) between rest and contraction and between rest and valsalva maneuver	Baseline and 6 months (change)
Levator hiatal area	Ultrasound-measured difference in levator hiatal area (cm^2) between rest and contraction and between rest and valsalva maneuver	Baseline, 6 months and 12 months (change)

Collaborators and Investigators

• Sponsor: Norwegian University of Science and Technology
• Collaborators: St. Olavs Hospital
• Investigators: Study Chair: Berit Schei, prof, Norwegian University of Science and Technology

Study record dates

Study Major Dates

• Study Start (Actual): September 18, 2018
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): June 1, 2024

Study Registration Dates

• First Submitted: July 5, 2018
• First Submitted That Met QC Criteria: August 17, 2018
• First Posted (Actual): August 21, 2018

Study Record Updates

• Last Update Posted (Actual): December 29, 2023
• Last Update Submitted That Met QC Criteria: December 28, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Physical Therapy Modalities
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Vulvar Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Chronic Pain; Vulvodynia
• Other Study ID Numbers: 2016/2150

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No