Multidisciplinary Treatment of Chronic Vulvar Pain

Chronic Pain Clinical Trial

Official title:

Multidisciplinary Treatment of Chronic Vulvar Pain - a Randomized Controlled Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03640624
• Other study ID #: 2016/2150
• Status: Recruiting
• Phase: N/A
• Start date: September 18, 2018
• Est. completion date: June 2024

Study information

• Verified date: December 2023
• Source: Norwegian University of Science and Technology
• Contact: Cecilie Therese Hagemann
• Phone: +47 97159869
• Email: cecilie.hagemann[@]ntnu.no
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 110
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Chronic Pain
• Vulvodynia

Intervention

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.
• 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)

Locations

Country	Name	City	State
Norway	Cecilie Hagemann	Trondheim

Sponsors (2)

Lead Sponsor	Collaborator
Norwegian University of Science and Technology	St. Olavs Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	Vulvar pressure pain threshold with vulvalgesiometer	Vulvar pressure pain threshold in Newton measured with a cotton tipped vulvalgesiometer	Baseline and 6 months (change)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)