VulvodyniaNCT03640624
Multidisciplinary Treatment of Chronic Vulvar Pain
A study testing Multidisciplinary treatment and Treatment as usual in people with Vulvodynia and Chronic Pain, run by Norwegian University of Science and Technology at 1 site in Norway.
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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Vulvodynia, Chronic Pain
- What is being tested?
- Multidisciplinary treatment and Treatment as usual
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 1 siteNorway
- Study dates
- 18 Sep 2018to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women aged 18 years and older
- Chronic vulvar pain for ≥3 months of duration
Who cannot join
- Insufficient Norwegian skills
- Intellectual disability or severe mental disorder
- Severe comorbidity making tailored care necessary (such as active cancer treatment)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Vulvodynia, Chronic Pain
- Being tested
- Multidisciplinary treatment, Treatment as usual
- Keywords
- Physical Therapy Modalities
- Medical subject headings
- Vulvodynia, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multidisciplinary treatmentCombination product
- 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 usualCombination product
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)
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Multidisciplinary treatment Receives: Combination Product: Multidisciplinary treatment |
| Control | Active comparator | Treatment as usual Receives: Combination Product: Treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Baseline, 3 months and 6 months (change)
Secondary outcomes (17)
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)
Measured: 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)
Measured: 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)
Measured: 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
Measured: Baseline and 6 months (change)
Vulvar pressure pain threshold with vulvalgesiometer
Vulvar pressure pain threshold in Newton measured with a cotton tipped vulvalgesiometer
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: Baseline, 6 months and 12 months (change)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2018
- Study start18 Sep 2018
- Primary completion10 Nov 2024
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VulvodyniaStudies of the same condition, open and under way.
- More trials run by Norwegian University of Science and TechnologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- St. Olavs Hospital
- Responsible party
- Sponsor
- Investigators
- Berit Schei, prof, Study chair, Norwegian University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03640624
- Sponsor's protocol ID
- 2016/2150
- Status last verified
- Dec 2025
- First submitted
- 5 Jul 2018
- Last updated
- 12 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multidisciplinary Treatment of Chronic Vulvar Pain - a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT03640624
- Acronym / sponsor ID
- 2016/2150
- Conditions
- Vulvodynia, Chronic Pain
- Keywords
- Physical Therapy Modalities
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Collaborators
- St. Olavs Hospital
- Study start
- 18 Sep 2018 (actual)
- Primary completion
- 10 Nov 2024 (actual)
- Study completion
- Jun 2027 (estimated)
- First posted
- 21 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Combination Product: Multidisciplinary treatmentMultidisciplinary treatment |
| Control | Active comparator | Combination Product: Treatment as usualTreatment as usual |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Women aged 18 years and older
- Chronic vulvar pain for ≥3 months of duration
Key exclusion criteria (3 listed)
- Insufficient Norwegian skills
- Intellectual disability or severe mental disorder
- Severe comorbidity making tailored care necessary (such as active cancer treatment)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multidisciplinary treatment1. 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 product | Intervention |
| Treatment as usualTreatment 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) | Combination product | Control |
Primary outcome
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)
17 secondary outcomes
Pain intensity with Brief pain inventory (BPI)
Time frame: Baseline, 3 months, 6 months and 12 months (change)
Pain intensity with tampon test
Time frame: Baseline and 6 months (change)
Pain intensity with tampon test
Time frame: Baseline, 6 months and 12 months (change)
Vulvar pressure pain threshold with vulvalgesiometer
Time frame: Baseline and 6 months (change)
Vulvar pressure pain threshold with vulvalgesiometer
Time frame: Baseline, 6 months and 12 months (change)
Pain intensity with Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2)
Time frame: Baseline and 6 months (change)
Pain intensity with Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2)
Time frame: Baseline, 6 months and 12 months (change)
Sexual distress with Female Sexual Distress Scale - revised (FSDS)
Time frame: Baseline and 6 months (change)
Sexual distress with Female Sexual Distress Scale - revised (FSDS)
Time frame: Baseline, 6 months and 12 months (change)
Affective symptoms with Hospital Anxiety and Depression Scale (HADS)
Time frame: Baseline and 6 months (change)
Affective symptoms with Hospital Anxiety and Depression Scale (HADS)
Time frame: Baseline, 6 months and 12 months (change)
Illness perception with Brief Illness Perception Questionnaire (BIPQ)
Time frame: Baseline and 6 months (change)
Illness perception with Brief Illness Perception Questionnaire (BIPQ)
Time frame: Baseline, 6 months and 12 months (change)
Pain catastrophizing with Pain Catastrophizing Scale (PCS)
Time frame: Baseline and 6 months (change)
Pain catastrophizing with Pain Catastrophizing Scale (PCS)
Time frame: Baseline, 6 months and 12 months (change)
Levator hiatal area
Time frame: Baseline and 6 months (change)
Levator hiatal area
Time frame: Baseline, 6 months and 12 months (change)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2025.
Related trials for Vulvodynia
Active, not recruitingPhase 2
A Phase 2 Study to Evaluate the Efficacy and Safety of Pudafensine in Vulvodynia (Provoked Vestibulodynia)
Vulvodynia
Not yet recruiting
Integrated Care Pathway for Hormonally Mediated Vestibulodynia: a Feasibility and Acceptability Pilot
Vestibulodynia, Vulvodynia
Active, not recruiting
Vestibulectomy Surgical Techniques Comparison Study
Vulvar Pain, Vulvodynia
Not yet recruiting
Transcutaneous Genital Nerves Stimulation for the Treatment of Refractory Chronic Pelvic and Genital Pain in Women.
Refractory Visceral Pelvic Pain, Refractory Genital Pain
Not yet recruitingPhase 2
A Pilot Study on the Efficacy of Oral Low Dose Naltrexone for Vulvodynia
Vulvodynia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Berit Schei, prof study chair
Norwegian University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multidisciplinary treatment and Treatment as usual in people with Vulvodynia and Chronic Pain, run by Norwegian University of Science and Technology at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 12 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity with Brief pain inventory (BPI) (time frame: Baseline, 3 months and 6 months (change)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2025.