Chronic Pain, Vulvodynia
Conditions
Keywords
Physical Therapy Modalities
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.
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.
Interventions
COMBINATION_PRODUCTMultidisciplinary treatment
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.
COMBINATION_PRODUCTTreatment 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)
Sponsors
St. Olavs Hospital
Norwegian University of Science and Technology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain intensity with Brief pain inventory (BPI) | 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
| Measure | Time frame | Description |
|---|---|---|
| Pain intensity with tampon test | 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) |
| Vulvar pressure pain threshold with vulvalgesiometer | Baseline and 6 months (change) | Vulvar pressure pain threshold in Newton measured with a cotton tipped vulvalgesiometer |
| Pain intensity with Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2) | 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. |
| Sexual distress with Female Sexual Distress Scale - revised (FSDS) | Baseline and 6 months (change) | Sexual distress measured with a 13-item Likert scale-based (0-4) questionnaire (FSDS). Mean score. |
| Pain intensity with Brief pain inventory (BPI) | 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) |
| Illness perception with Brief Illness Perception Questionnaire (BIPQ) | Baseline and 6 months (change) | Illness perception measured with a 8-Item NRS-based (0-10) questionnaire. Mean score of total scale. |
| Pain catastrophizing with Pain Catastrophizing Scale (PCS) | Baseline and 6 months (change) | Pain catastrophizing measured with a 13-Item Likert scale-based (0-4) questionnaire (PCS). Total score. |
| Levator hiatal area | Baseline and 6 months (change) | Ultrasound-measured difference in levator hiatal area (cm\^2) between rest and contraction and between rest and valsalva maneuver |
| Affective symptoms with Hospital Anxiety and Depression Scale (HADS) | 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. |
Countries
Norway
Outcome results
None listed