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Multidisciplinary Treatment of Chronic Vulvar Pain

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ClinicalTrials.gov Identifier: NCT03640624
Recruitment Status : Recruiting
First Posted : August 21, 2018
Last Update Posted : September 19, 2018
Sponsor:
Collaborator:
St. Olavs Hospital
Information provided by (Responsible Party):
Norwegian University of Science and Technology

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.

Condition or disease Intervention/treatment Phase
Vulvodynia Chronic Pain Combination Product: Multidisciplinary treatment Combination Product: Treatment as usual Not Applicable

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, 6 months and 12 months after inclusion.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Multidisciplinary Treatment of Chronic Vulvar Pain - a Randomized Controlled Study
Actual Study Start Date : September 18, 2018
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : February 2021

Arm Intervention/treatment
Experimental: Intervention
Multidisciplinary treatment
Combination Product: Multidisciplinary 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.

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 months)




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03640624


Contacts
Contact: Per Kristen Teigen +47 97159869 per.k.teigen@ntnu.no

Locations
Norway
St Olavs Hospital Kvinneklinikk Recruiting
Trondheim, Norway
Contact: Per Kristen Teigen       per.k.teigen@ntnu.no   
Sponsors and Collaborators
Norwegian University of Science and Technology
St. Olavs Hospital
Investigators
Study Director: Siri Forsmo, prof Norwegian University of Science and Technology

Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT03640624     History of Changes
Other Study ID Numbers: 2016/2150
First Posted: August 21, 2018    Key Record Dates
Last Update Posted: September 19, 2018
Last Verified: September 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Norwegian University of Science and Technology:
Physical Therapy Modalities

Additional relevant MeSH terms:
Chronic Pain
Vulvodynia
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Vulvar Diseases
Genital Diseases, Female