Multidisciplinary Treatment of Chronic Vulvar Pain
Primary Purpose
Vulvodynia, Chronic Pain
Status
Recruiting
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Multidisciplinary treatment
Treatment as usual
Sponsored by
About this trial
This is an interventional treatment trial for Vulvodynia focused on measuring Physical Therapy Modalities
Eligibility 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)
Sites / Locations
- Cecilie HagemannRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Intervention
Control
Arm Description
Multidisciplinary treatment
Treatment as usual
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
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)
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)
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)
Vulvar pressure pain threshold with vulvalgesiometer
Vulvar pressure pain threshold in Newton measured with a cotton tipped vulvalgesiometer
Vulvar pressure pain threshold with vulvalgesiometer
Vulvar pressure pain threshold in Newton measured with a cotton tipped vulvalgesiometer
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.
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.
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.
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.
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.
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.
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.
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.
Pain catastrophizing with Pain Catastrophizing Scale (PCS)
Pain catastrophizing measured with a 13-Item Likert scale-based (0-4) questionnaire (PCS). Total score.
Pain catastrophizing with Pain Catastrophizing Scale (PCS)
Pain catastrophizing measured with a 13-Item Likert scale-based (0-4) questionnaire (PCS). Total score.
Levator hiatal area
Ultrasound-measured difference in levator hiatal area (cm^2) between rest and contraction and between rest and valsalva maneuver
Levator hiatal area
Ultrasound-measured difference in levator hiatal area (cm^2) between rest and contraction and between rest and valsalva maneuver
Full Information
NCT ID
NCT03640624
First Posted
July 5, 2018
Last Updated
December 5, 2022
Sponsor
Norwegian University of Science and Technology
Collaborators
St. Olavs Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03640624
Brief Title
Multidisciplinary Treatment of Chronic Vulvar Pain
Official Title
Multidisciplinary Treatment of Chronic Vulvar Pain - a Randomized Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 18, 2018 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
June 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Norwegian University of Science and Technology
Collaborators
St. Olavs Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vulvodynia, Chronic Pain
Keywords
Physical Therapy Modalities
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
110 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Multidisciplinary treatment
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Treatment as usual
Intervention Type
Combination Product
Intervention Name(s)
Multidisciplinary treatment
Intervention Description
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.
Intervention Type
Combination Product
Intervention Name(s)
Treatment as usual
Intervention Description
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 Outcome Measure Information:
Title
Pain intensity with Brief pain inventory (BPI)
Description
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)
Time Frame
Baseline, 3 months and 6 months (change)
Secondary Outcome Measure Information:
Title
Pain intensity with Brief pain inventory (BPI)
Description
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)
Time Frame
Baseline, 3 months, 6 months and 12 months (change)
Title
Pain intensity with tampon test
Description
Intensity of pain with tampon insertion and removal (tampon test) measured on a 0-10 numerical rating scale (0 minimum and 10 maximum pain)
Time Frame
Baseline and 6 months (change)
Title
Pain intensity with tampon test
Description
Intensity of pain with tampon insertion and removal (tampon test) measured on a 0-10 numerical rating scale (0 minimum and 10 maximum pain)
Time Frame
Baseline, 6 months and 12 months (change)
Title
Vulvar pressure pain threshold with vulvalgesiometer
Description
Vulvar pressure pain threshold in Newton measured with a cotton tipped vulvalgesiometer
Time Frame
Baseline and 6 months (change)
Title
Vulvar pressure pain threshold with vulvalgesiometer
Description
Vulvar pressure pain threshold in Newton measured with a cotton tipped vulvalgesiometer
Time Frame
Baseline, 6 months and 12 months (change)
Title
Pain intensity with Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2)
Description
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.
Time Frame
Baseline and 6 months (change)
Title
Pain intensity with Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2)
Description
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.
Time Frame
Baseline, 6 months and 12 months (change)
Title
Sexual distress with Female Sexual Distress Scale - revised (FSDS)
Description
Sexual distress measured with a 13-item Likert scale-based (0-4) questionnaire (FSDS). Mean score.
Time Frame
Baseline and 6 months (change)
Title
Sexual distress with Female Sexual Distress Scale - revised (FSDS)
Description
Sexual distress measured with a 13-item Likert scale-based (0-4) questionnaire (FSDS). Mean score.
Time Frame
Baseline, 6 months and 12 months (change)
Title
Affective symptoms with Hospital Anxiety and Depression Scale (HADS)
Description
Affective symptoms measured with a 14-item Likert scale-based (0-3) questionnaire (HADS). Both total and subscale (depression and anxiety) scores.
Time Frame
Baseline and 6 months (change)
Title
Affective symptoms with Hospital Anxiety and Depression Scale (HADS)
Description
Affective symptoms measured with a 14-item Likert scale-based (0-3) questionnaire (HADS). Both total and subscale (depression and anxiety) scores.
Time Frame
Baseline, 6 months and 12 months (change)
Title
Illness perception with Brief Illness Perception Questionnaire (BIPQ)
Description
Illness perception measured with a 8-Item NRS-based (0-10) questionnaire. Mean score of total scale.
Time Frame
Baseline and 6 months (change)
Title
Illness perception with Brief Illness Perception Questionnaire (BIPQ)
Description
Illness perception measured with a 8-Item NRS-based (0-10) questionnaire. Mean score of total scale.
Time Frame
Baseline, 6 months and 12 months (change)
Title
Pain catastrophizing with Pain Catastrophizing Scale (PCS)
Description
Pain catastrophizing measured with a 13-Item Likert scale-based (0-4) questionnaire (PCS). Total score.
Time Frame
Baseline and 6 months (change)
Title
Pain catastrophizing with Pain Catastrophizing Scale (PCS)
Description
Pain catastrophizing measured with a 13-Item Likert scale-based (0-4) questionnaire (PCS). Total score.
Time Frame
Baseline, 6 months and 12 months (change)
Title
Levator hiatal area
Description
Ultrasound-measured difference in levator hiatal area (cm^2) between rest and contraction and between rest and valsalva maneuver
Time Frame
Baseline and 6 months (change)
Title
Levator hiatal area
Description
Ultrasound-measured difference in levator hiatal area (cm^2) between rest and contraction and between rest and valsalva maneuver
Time Frame
Baseline, 6 months and 12 months (change)
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cecilie Therese Hagemann
Phone
+47 97159869
Email
cecilie.hagemann@ntnu.no
First Name & Middle Initial & Last Name or Official Title & Degree
Ingrid Volløyhaug
Phone
97549124
Email
ingrid.volloyhaug@ntnu.no
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Berit Schei, prof
Organizational Affiliation
Norwegian University of Science and Technology
Official's Role
Study Chair
Facility Information:
Facility Name
Cecilie Hagemann
City
Trondheim
ZIP/Postal Code
7006
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cecilie Therese Hagemann
Phone
95829490
Email
cecilie.hagemann@ntnu.no
First Name & Middle Initial & Last Name & Degree
Ragnhild Mork Andresen
12. IPD Sharing Statement
Learn more about this trial
Multidisciplinary Treatment of Chronic Vulvar Pain
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