VulvodyniaProLoVeNCT04613713
Somatocognitive Therapy in Treatment of Provoked (Localized) Vestibulodynia - Randomized Clinical Trial (ProLoVe Study)
A study testing Somatocognitive physiotherapy and Treatment as usual in people with Vulvodynia and Vestibulodynia, run by Oslo Metropolitan University at 1 site in Norway.
Trial summary
This is a two-arm randomized clinical trial assessing effectiveness of somatocognitive therapy versus treatment as usual for provoked vestibulodynia (PVD). PVD is a common, but under-treated persistent pain condition, mostly affecting young women in their late teens and early 20s. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Vulvodynia, Vestibulodynia
- What is being tested?
- Somatocognitive physiotherapy and Treatment as usual
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteNorway
- Study dates
- 1 Jan 2021to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Clinical diagnosis of provoked vestibulodynia
- Age: 18 to 35
- Must understand Norwegian well enough to be able to complete questionnaires
- Must be able to attend treatment in Oslo, Norway
Who cannot join
- Active infection in the vulvar region
- Dermatologic lesion in the vulvar region
- Presence of diagnostically confirmed psychiatric condition that necessitate treatment by a medical specialist in psychiatry of clinical psychology
Trial locations and contacts
1 site in 1 country.
Norway1 site, 1 recruiting
- Recruiting
Oslo Metropolitan University
Oslo, 0130
Slawomir Wojniusz, PhD, +4741926564, slawomir@oslomet.no
About this study
Official title: Effectiveness and Cost-utility of Somatocognitive Therapy Versus Treatment as Usual for Provoked (Localized) Vestibulodynia - a Randomized Clinical Trial (ProLoVe Study)
This is a two-arm randomized clinical trial assessing effectiveness of somatocognitive therapy versus treatment as usual for provoked vestibulodynia (PVD). PVD is a common, but under-treated persistent pain condition, mostly affecting young women in their late teens and early 20s. It is the most frequent cause of pain during sexual intercourse affecting around 10% of women in the general population. There are no generally accepted evidence-based guidelines for the medical management of PVD. The most commonly used treatments are topical (85%), physiotherapy (52%), and oral medications (45%). High quality randomized clinical trials testing effectiveness of various therapy approaches are urgently needed.
Somatocognitive therapy SCT is a multi-modal physiotherapy approach developed for alleviating musculoskeletal persistent pain conditions. SCT has been previously evaluated in the treatment of women with chronic pelvic pain.
Read more
In the current study, 128 women with PVD will be randomized into SCT and treatment as usual (TAU) group. Participants will be assessed at baseline, after 6 months and after 12 months. The main outcome will be changes in female sexual function index scored at 12 months follow up. Secondary outcomes include pain intensity as assessed by a tampon test as well as a number of questionnaires recording different aspects of emotional and cognitive functioning. In addition cost-effectiveness analysis of SCT versus TAU will be performed.
Participants in the SCT group will receive up to 15 therapy sessions and will additionally be offered one booster session at 6 months after treatment ending. TAU group will follow treatment options of their own choice based on recommendations from the Vulva clinic at Oslo University Hospital, a center that is specialized in treating women with vulvar pain conditions.
Read the detailed description
Objectives:
The main objectives of the ProLoVe study are:
- To assess clinical effectiveness of somatocognitive therapy (SCT) versus treatment as usual (TAU) in provoked vestibulodynia (PVD).
- To identify prognostic factors associated with treatment outcome
- To assess cost-effectiveness and cost-utility of SCT vs TAU.
Study design:
The study is a two-arm, single center randomized clinical trial with a 1:1 allocation ratio, recruiting patients with PVD diagnosis. The participants will be randomized to either somatocognitive therapy (SCT) or treatment as usual (TAU) group after baseline assessment. Randomization will be stratified by type of PVD (primary or secondary), since primary PVD is considered to be more treatment resistant.
Recruitment procedure:
Participants' eligibility will be evaluated by the medical specialist in gynecology or dermatology. During medical consultation an eligible patient will be verbally informed about the study and receive an information leaflet about the project. Number of eligible patients informed about the study, will be registered. Interested women will contact the primary investigator who will set up a meeting. Detailed information about the trial, the assessment instruments and existing treatment options will be provided. Women willing to pursue study participation will sign an informed consent.
Randomization and blinding:
An administrative coordinator, not directly involved in the study, will be responsible for randomization of the participants using a computer random number generator, and will be responsible for the secure storage of randomization results. The participants will be randomized to either somatocognitive physiotherapy (SCT) or treatment as usual group (TAU) at 1:1 allocation rate. Randomization will be stratified by severity (primary/secondary PVD). Blinding of the participants regarding group belonging is not possible.
Data collection:
All quantitative instruments will be distributed as electronic forms (nettskjema.no) and directly transferred to the Service for Sensitive Data (TSD). Choice and implementation of assessment instruments is based on the Recommendations for the study of the vulvar pain in women, part I: review of assessment tools (Rosen et al. 2020), feedback from participants from the feasibility study and discussions with user representative (former PVD patient). Three assessment time points are planned: baseline, 6 months follow up, and 12 months follow up.
Sample size assessment:
Power analysis suggests that 128 participants split equally between two study arms will be enough to reveal the between group difference in total FSFI score changes, from baseline to 12 months follow-up, of at least 3 points (SD = 6.0) as statistically significant, using α = 0.05 and 1-β = 0.8. In a feasibility study (n=10) an average of 6 points improvement on FSFI in course of 8 months in patients treated with SCT was observed.
Data analysis:
Objective 1: To assess clinical effectiveness of somatocognitive therapy (SCT) versus treatment as usual (TAU) in provoked vestibulodynia (PVD).
Hypothesis 1: In treatment of PVD, the effectiveness of somatocognitive therapy is not significantly different from treatment as usual as evaluated by changes in FSFI total score from baseline to 12 months follow-up
Independently, a senior statistician and PhD student blinded to treatment group will perform intention to treat analyses of the treatment effect on the primary outcome by using linear mixed model for repeated measures.
Subgroup analysis (objective 1) Some of the women with PVD do not engage in penetrative sex and thus score 0 at the FSFI pain sub-scale. This influences the psychometric properties of FSFI and it is recommended to exclude the pain sub-scale from the analysis in those cases. Therefore, additional analyzes will be performed on the subgroups of women who did and did not have penetrative sex during the 4 weeks prior to FSFI completion using the same statistical approaches as for hypothesis 1.
Objective 2: To identify prognostic factors associated with treatment outcome
For prognostic analyses, changes in FSFI scores between baseline and 12 months follow up as the dependent variable will be used. Further, an association model to assess possible associations between selected variables and the main outcome will be constructed. The variables that reached the level of significance of at least 0.10 in univariate analyses will be entered into multiple regression models. To avoid over-fitting, at most, one variable per 10 events will be included. In addition, highly correlated covariates (>0.7) will not be included in the final model.
Objective 3: To assess cost-effectiveness and cost-utility of SCT vs TAU.
The cost-effectiveness analysis will be carried out from a healthcare and society perspective, comparing the treatment effect and health utilities by using the EuroQoL 5D (EQ-5D-5L) utility index. Health gains will be expressed as quality-adjusted life years (QALYs) derived from the EQ-5D-5L utility scores. Costs to the healthcare system and society (production loss) due to PVD will be estimated based on data recorded at the follow-ups including visits to general practitioner, medical specialist, physical therapist, manual therapist or other physical therapy specialist, and other therapists (e.g. chiropractor, osteopath, psychologist); number of days of hospitalization and/or rehabilitation; use of medication). Data concerning production loss will include work status in terms of working time (percentage of position), partial sick leave (percentage, duration, and reason), complete sick leave (duration and reason), disability pension (percentage, duration, and reason), unemployment (yes, no), and student/other/unknown (yes, no).
Secondary analysis
Proportion comparisons of women who experienced successful treatment outcome in SCT and TAU group will be analyzed using global perceived effect scale at 12 months follow up applying logistic regression for repeated measures. Within and between group differences in other secondary outcomes will be evaluated using linear mixed model for repeated measures.
Exploratory analysis in TAU group Participants in the TAU group may choose a variety of different treatment options, e.g. other types of physiotherapy, osteopathy, chiropractor treatment, etc. Exploratory analysis will be conducted to identify the most promising treatments with respect to improvement on the FSFI using repeated measures analysis of variance. The goal of these analyses is to identify candidate treatments for future studies.
In all analyses, the between-group mean differences with 95% confidence intervals (CI) or odds ratio (OR) with 95% CI for categorical outcomes will be reported. Missing data will be replaced using multiple imputation methods.
- Conditions
- Vulvodynia, Vestibulodynia
- Being tested
- Somatocognitive physiotherapy, Treatment as usual
- Keywords
- Provoked vestibulodynia, Dyspareunia, Somatocognitive therapy, Physiotherapy, Randomised clinical trial, Women's health, Sexual dysfunction, Pain management
- Medical subject headings
- Vulvodynia, Dyspareunia, Sexual Dysfunction, Physiological, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Somatocognitive physiotherapyOther
The main intervention areas include:
- education about the PVD, healthy vulvo-vaginal and sexual behaviors, nature of chronic pain and factors influencing pain intensity
- bodily exercises and techniques increasing body awareness, ability to relax and control muscle tension and respiration pattern in different situations
- techniques to cope with emotions and thoughts related to bodily experiences and to PVD
- structured homework assignments promoting application of the learned techniques in daily situations and gradual exposure of the patient to activities associated with pain.
Participants will be offered maximally 15 treatment sessions. No minimal number of sessions is set. Treatment will be conducted by female physiotherapists experienced in treating long-standing pain conditions.
Treatment as usualOther
The participants will follow the current treatment advice as recommended by the Vulva Clinic at OUH, a tertiary health care center specialized in treatment of vulvar disorders. Advice include guidance about the management of PVD as a condition, use of medication, physiotherapy, sexologist and psychological counseling, usage of internet resources (vulva.no) and others. Participants will be free to pursue treatment options of their choice. The type of treatment, number of treatments and medication usage will be monitored by bi-weekly electronic forms during the whole study period.
| Study group | Role | What they receive |
|---|---|---|
| Somatocognitive physiotherapy | Experimental | Somatocognitive therapy is a multi-modal physiotherapy intervention utilized for women with longstanding chronic pelvic pain and provoked vestibulodynia developed at the beginning of the 2000s as a collaboration between the department of psychosomatic medicine, Oslo University Hospital (OUH) and department of physiotherapy (OsloMet) Receives: Other: Somatocognitive physiotherapy |
| Treatment as usual | Active comparator | The participants randomized to the treatment as usual group will follow available treatment options based on the current recommendations from Vulva clinic at Oslo University Hospital, a center that is specialized in treatment of vulvar conditions. Receives: Other: Treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in female sexual function index (FSFI) (Rosen et al. 2000)
A multidimensional scale assessing key dimensions of female sexual function. The FSFI is a 19-item self-report questionnaire designed to measure sexual functioning in women. It assesses six domains of sexual function: sexual desire, sexual arousal, lubrication, orgasm, satisfaction, and pain (i.e., pain associated with vaginal penetration). Higher scores indicate better sexual functioning.
Measured: Baseline, 6 and 12 months follow up
Secondary outcomes (10)
Change in Participant Perceived Improvement (PGIC) (Dworkin et al. 2005)
Participants are asked to rate on a 7-points Likert scale how much their condition has changed since baseline measurement. Answering alternatives: very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse
Measured: 6 and 12 months follow up
Change in the tampon test (Foster et al. 2009)
The tampon test measures vulvar pain intensity during insertion and removal of a standard sanitary tampon. At each assessment time (baseline, 6 and 12 months follow up), the test will be performed three times at home during a 7-day period, on days 1, 4 and 7. A mean value of these 3 measurements will be used as a measure of pain sensitivity. Pain intensity is recorded on the Numeric Rating Scale (0-10) where 0 is no pain and 10 is the worst pain imaginable.
Measured: Baseline, 6 and 12 months follow up
Change in recalled pain intensity during intercourse
Participant is asked to score on a Numeric Rating Scale (0-10) how intense was the pain during last intercourse, where 0 is no pain and 10 is the worst pain imaginable.
Measured: Baseline, 6 and 12 months follow up
Change in Vulvar Pain Assessment Questionnaire (VPAQ) (Dargie et al. 2017) - life interference
VPAQ is developed to assist in the assessment and diagnosis of vulvodynia. Life interference sub-scale describes impact of vulvodynia on daily living. It consists of 11 questions addressing different domains of daily functioning. Each question is scored on a 6-points Likert scale with a higher score indicating higher negative impact of vulvodynia on daily activities
Measured: Baseline, 6 and 12 months follow up
Change in Vulvar Pain Assessment Questionnaire (VPAQ) (Dargie et al. 2017) - coping strategies
VPAQ - coping strategies sub-scale consists of 12 statements describing different pain-coping strategies. Each statement is scored on a 5-points Likert scale referring to how often a specific strategy is used. A higher score indicate more frequent use of a given strategy.
Measured: Baseline, 6 and 12 months follow up
Change in vulvodynia related self-efficacy
The scale will be assessed to record participant's belief in her ability to cope with the vulvodynia symptoms on her own. The scale is based on one question scored on 5-points Likert scale with higher scores indicating higher belief in woman's ability to cope with her symptoms.
Measured: Baseline, 6 and 12 months follow up
Change in pain catastrophizing scale (Fernandes et al. 2012)
The pain catastrophizing scale is a self-report measure consisting of 13 items scored from 0 to 4. The higher the score, the more catastrophizing thoughts are present. It assesses an impact of negative cognition's and catastrophizing on pain experience. This version of the scale has been specifically adapted for pain related to vulvodynia.
Measured: Baseline, 6 and 12 months follow up
Change in Rumination Response Scale (RRS-10) (Parola et al. 2017)
Rumination and worry express a method of coping with negative emotions and feelings that is characterized by self-focused attention, repetitive focus on negative emotions and self-reflection. RSS-10 includes 10 questions scored on a 4-points Likert scale. The higher scores indicate more worry and rumination.
Measured: Baseline, 6 and 12 months follow up
Change in Hopkins Symptoms Check List (HSCL-25) (Derogatis et al.1974)
HSCL-25 evaluates psychological distress related to the anxiety and depression symptoms. It consists of 25 questions scored on a 4-points Likert scale. Higher scores indicate higher levels of psychological distress.
Measured: Baseline, 6 and 12 months follow up
Change in EQ-5D-5L (Herdman et al. 2011)
EQ-5D-5L is used to assess health related quality of life and/or cost-effectiveness of assessed interventions. It consists of 5 domains scored on 5-points Likert scale with higher scores indicating lower quality of life. Additionally 100 points NRS scale is used for evaluation of current health status with higher score indicating better health.
Measured: Baseline, 6 and 12 months follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2020
- Study start1 Jan 2021
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for VulvodyniaStudies of the same condition, open and under way.
- 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
- Model description
- Parallel group randomized clinical trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oslo Metropolitan University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Slawomir Wojniusz, Phd, Principal investigator, Oslo Metropolitan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04613713
- Sponsor's protocol ID
- 29295
- Acronym
- ProLoVe
- Status last verified
- Apr 2022
- First submitted
- 26 Oct 2020
- Last updated
- 21 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rosen R, Brown C, Heiman J, Leiblum S, Meston C, Shabsigh R, Ferguson D, D'Agostino R Jr. The Female Sexual Function Index (FSFI): a multidimensional self-report instrument for the assessment of female sexual function. J Sex Marital Ther. 2000 Apr-Jun;26(2):191-208. doi: 10.1080/009262300278597.
PubMed 10782451Dworkin RH, Turk DC, Farrar JT, Haythornthwaite JA, Jensen MP, Katz NP, Kerns RD, Stucki G, Allen RR, Bellamy N, Carr DB, Chandler J, Cowan P, Dionne R, Galer BS, Hertz S, Jadad AR, Kramer LD, Manning DC, Martin S, McCormick CG, McDermott MP, McGrath P, Quessy S, Rappaport BA, Robbins W, Robinson JP, Rothman M, Royal MA, Simon L, Stauffer JW, Stein W, Tollett J, Wernicke J, Witter J; IMMPACT. Core outcome measures for chronic pain clinical trials: IMMPACT recommendations. Pain. 2005 Jan;113(1-2):9-19. doi: 10.1016/j.pain.2004.09.012. No abstract available.
PubMed 15621359Foster DC, Beth Kotok M, Huang LS, Watts A, Oakes D, Howard FM, Stodgell CJ, Dworkin RH. The tampon test for vulvodynia treatment outcomes research: reliability, construct validity, and responsiveness. Obstet Gynecol. 2009 Apr;113(4):825-832. doi: 10.1097/AOG.0b013e31819bda7c.
PubMed 19305326Dargie E, Holden RR, Pukall CF. The Vulvar Pain Assessment Questionnaire: Factor Structure, Preliminary Norms, Internal Consistency, and Test-Retest Reliability. J Sex Med. 2017 Dec;14(12):1585-1596. doi: 10.1016/j.jsxm.2017.10.072.
PubMed 29198513Fernandes L, Storheim K, Lochting I, Grotle M. Cross-cultural adaptation and validation of the Norwegian pain catastrophizing scale in patients with low back pain. BMC Musculoskelet Disord. 2012 Jun 22;13:111. doi: 10.1186/1471-2474-13-111.
PubMed 22726668Parola N, Zendjidjian XY, Alessandrini M, Baumstarck K, Loundou A, Fond G, Berna F, Lancon C, Auquier P, Boyer L. Psychometric properties of the Ruminative Response Scale-short form in a clinical sample of patients with major depressive disorder. Patient Prefer Adherence. 2017 May 12;11:929-937. doi: 10.2147/PPA.S125730. eCollection 2017.
PubMed 28553085Derogatis LR, Lipman RS, Rickels K, Uhlenhuth EH, Covi L. The Hopkins Symptom Checklist (HSCL): a self-report symptom inventory. Behav Sci. 1974 Jan;19(1):1-15. doi: 10.1002/bs.3830190102. No abstract available.
PubMed 4808738Herdman M, Gudex C, Lloyd A, Janssen M, Kind P, Parkin D, Bonsel G, Badia X. Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L). Qual Life Res. 2011 Dec;20(10):1727-36. doi: 10.1007/s11136-011-9903-x. Epub 2011 Apr 9.
PubMed 21479777Rosen NO, Bergeron S, Pukall CF. Recommendations for the Study of Vulvar Pain in Women, Part 1: Review of Assessment Tools. J Sex Med. 2020 Feb;17(2):180-194. doi: 10.1016/j.jsxm.2019.10.023. Epub 2019 Dec 4.
PubMed 31812684
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Cost-utility of Somatocognitive Therapy Versus Treatment as Usual for Provoked (Localized) Vestibulodynia - a Randomized Clinical Trial (ProLoVe Study)
- ClinicalTrials.gov ID
- NCT04613713
- Acronym / sponsor ID
- ProLoVe / 29295
- Conditions
- Vulvodynia, Vestibulodynia
- Keywords
- Provoked vestibulodynia, Dyspareunia, Somatocognitive therapy, Physiotherapy, Randomised clinical trial, Women's health, Sexual dysfunction, Pain management
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- Oslo Metropolitan UniversityUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 3 Nov 2020 (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.
This is a two-arm randomized clinical trial assessing effectiveness of somatocognitive therapy versus treatment as usual for provoked vestibulodynia (PVD). PVD is a common, but under-treated persistent pain condition, mostly affecting young women in their late teens and early 20s. It is the most frequent cause of pain during sexual intercourse affecting around 10% of women in the general population. There are no generally accepted evidence-based guidelines for the medical management of PVD. The most commonly used treatments are topical (85%), physiotherapy (52%), and oral medications (45%). High quality randomized clinical trials testing effectiveness of various therapy approaches are urgently needed.
Somatocognitive therapy SCT is a multi-modal physiotherapy approach developed for alleviating musculoskeletal persistent pain conditions. SCT has been previously evaluated in the treatment of women with chronic pelvic pain.
In the current study, 128 women with PVD will be randomized into SCT and treatment as usual (TAU) group. Participants will be assessed at baseline, after 6 months and after 12 months. The main outcome will be changes in female sexual function index scored at 12 months follow up. Secondary outcomes include pain intensity as assessed by a tampon test as well as a number of questionnaires recording different aspects of emotional and cognitive functioning. In addition cost-effectiveness analysis of SCT versus TAU will be performed.
Participants in the SCT group will receive up to 15 therapy sessions and will additionally be offered one booster session at 6 months after treatment ending. TAU group will follow treatment options of their own choice based on recommendations from the Vulva clinic at Oslo University Hospital, a center that is specialized in treating women with vulvar pain conditions.
Detailed description
Objectives:
The main objectives of the ProLoVe study are:
- To assess clinical effectiveness of somatocognitive therapy (SCT) versus treatment as usual (TAU) in provoked vestibulodynia (PVD).
- To identify prognostic factors associated with treatment outcome
- To assess cost-effectiveness and cost-utility of SCT vs TAU.
Study design:
The study is a two-arm, single center randomized clinical trial with a 1:1 allocation ratio, recruiting patients with PVD diagnosis. The participants will be randomized to either somatocognitive therapy (SCT) or treatment as usual (TAU) group after baseline assessment. Randomization will be stratified by type of PVD (primary or secondary), since primary PVD is considered to be more treatment resistant.
Recruitment procedure:
Participants' eligibility will be evaluated by the medical specialist in gynecology or dermatology. During medical consultation an eligible patient will be verbally informed about the study and receive an information leaflet about the project. Number of eligible patients informed about the study, will be registered. Interested women will contact the primary investigator who will set up a meeting. Detailed information about the trial, the assessment instruments and existing treatment options will be provided. Women willing to pursue study participation will sign an informed consent.
Randomization and blinding:
An administrative coordinator, not directly involved in the study, will be responsible for randomization of the participants using a computer random number generator, and will be responsible for the secure storage of randomization results. The participants will be randomized to either somatocognitive physiotherapy (SCT) or treatment as usual group (TAU) at 1:1 allocation rate. Randomization will be stratified by severity (primary/secondary PVD). Blinding of the participants regarding group belonging is not possible.
Data collection:
All quantitative instruments will be distributed as electronic forms (nettskjema.no) and directly transferred to the Service for Sensitive Data (TSD). Choice and implementation of assessment instruments is based on the Recommendations for the study of the vulvar pain in women, part I: review of assessment tools (Rosen et al. 2020), feedback from participants from the feasibility study and discussions with user representative (former PVD patient). Three assessment time points are planned: baseline, 6 months follow up, and 12 months follow up.
Sample size assessment:
Power analysis suggests that 128 participants split equally between two study arms will be enough to reveal the between group difference in total FSFI score changes, from baseline to 12 months follow-up, of at least 3 points (SD = 6.0) as statistically significant, using α = 0.05 and 1-β = 0.8. In a feasibility study (n=10) an average of 6 points improvement on FSFI in course of 8 months in patients treated with SCT was observed.
Data analysis:
Objective 1: To assess clinical effectiveness of somatocognitive therapy (SCT) versus treatment as usual (TAU) in provoked vestibulodynia (PVD).
Hypothesis 1: In treatment of PVD, the effectiveness of somatocognitive therapy is not significantly different from treatment as usual as evaluated by changes in FSFI total score from baseline to 12 months follow-up
Independently, a senior statistician and PhD student blinded to treatment group will perform intention to treat analyses of the treatment effect on the primary outcome by using linear mixed model for repeated measures.
Subgroup analysis (objective 1) Some of the women with PVD do not engage in penetrative sex and thus score 0 at the FSFI pain sub-scale. This influences the psychometric properties of FSFI and it is recommended to exclude the pain sub-scale from the analysis in those cases. Therefore, additional analyzes will be performed on the subgroups of women who did and did not have penetrative sex during the 4 weeks prior to FSFI completion using the same statistical approaches as for hypothesis 1.
Objective 2: To identify prognostic factors associated with treatment outcome
For prognostic analyses, changes in FSFI scores between baseline and 12 months follow up as the dependent variable will be used. Further, an association model to assess possible associations between selected variables and the main outcome will be constructed. The variables that reached the level of significance of at least 0.10 in univariate analyses will be entered into multiple regression models. To avoid over-fitting, at most, one variable per 10 events will be included. In addition, highly correlated covariates (>0.7) will not be included in the final model.
Objective 3: To assess cost-effectiveness and cost-utility of SCT vs TAU.
The cost-effectiveness analysis will be carried out from a healthcare and society perspective, comparing the treatment effect and health utilities by using the EuroQoL 5D (EQ-5D-5L) utility index. Health gains will be expressed as quality-adjusted life years (QALYs) derived from the EQ-5D-5L utility scores. Costs to the healthcare system and society (production loss) due to PVD will be estimated based on data recorded at the follow-ups including visits to general practitioner, medical specialist, physical therapist, manual therapist or other physical therapy specialist, and other therapists (e.g. chiropractor, osteopath, psychologist); number of days of hospitalization and/or rehabilitation; use of medication). Data concerning production loss will include work status in terms of working time (percentage of position), partial sick leave (percentage, duration, and reason), complete sick leave (duration and reason), disability pension (percentage, duration, and reason), unemployment (yes, no), and student/other/unknown (yes, no).
Secondary analysis
Proportion comparisons of women who experienced successful treatment outcome in SCT and TAU group will be analyzed using global perceived effect scale at 12 months follow up applying logistic regression for repeated measures. Within and between group differences in other secondary outcomes will be evaluated using linear mixed model for repeated measures.
Exploratory analysis in TAU group Participants in the TAU group may choose a variety of different treatment options, e.g. other types of physiotherapy, osteopathy, chiropractor treatment, etc. Exploratory analysis will be conducted to identify the most promising treatments with respect to improvement on the FSFI using repeated measures analysis of variance. The goal of these analyses is to identify candidate treatments for future studies.
In all analyses, the between-group mean differences with 95% confidence intervals (CI) or odds ratio (OR) with 95% CI for categorical outcomes will be reported. Missing data will be replaced using multiple imputation methods.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel group randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| Somatocognitive physiotherapy | Experimental | Other: Somatocognitive physiotherapySomatocognitive therapy is a multi-modal physiotherapy intervention utilized for women with longstanding chronic pelvic pain and provoked vestibulodynia developed at the beginning of the 2000s as a collaboration between the department of psychosomatic medicine, Oslo University Hospital (OUH) and department of physiotherapy (OsloMet) |
| Treatment as usual | Active comparator | Other: Treatment as usualThe participants randomized to the treatment as usual group will follow available treatment options based on the current recommendations from Vulva clinic at Oslo University Hospital, a center that is specialized in treatment of vulvar conditions. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Clinical diagnosis of provoked vestibulodynia
- Age: 18 to 35
- Must understand Norwegian well enough to be able to complete questionnaires
- Must be able to attend treatment in Oslo, Norway
Key exclusion criteria (3 listed)
- Active infection in the vulvar region
- Dermatologic lesion in the vulvar region
- Presence of diagnostically confirmed psychiatric condition that necessitate treatment by a medical specialist in psychiatry of clinical psychology
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 |
|---|---|---|
| Somatocognitive physiotherapyThe main intervention areas include: 1. education about the PVD, healthy vulvo-vaginal and sexual behaviors, nature of chronic pain and factors influencing pain intensity 2. bodily exercises and techniques increasing body awareness, ability to relax and control muscle tension and respiration pattern in different situations 3. techniques to cope with emotions and thoughts related to bodily experiences and to PVD 4. structured homework assignments promoting application of the learned techniques in daily situations and gradual exposure of the patient to activities associated with pain. Participants will be offered maximally 15 treatment sessions. No minimal number of sessions is set. Treatment will be conducted by female physiotherapists experienced in treating long-standing pain conditions. | Other | Somatocognitive physiotherapy |
| Treatment as usualThe participants will follow the current treatment advice as recommended by the Vulva Clinic at OUH, a tertiary health care center specialized in treatment of vulvar disorders. Advice include guidance about the management of PVD as a condition, use of medication, physiotherapy, sexologist and psychological counseling, usage of internet resources (vulva.no) and others. Participants will be free to pursue treatment options of their choice. The type of treatment, number of treatments and medication usage will be monitored by bi-weekly electronic forms during the whole study period. | Other | Treatment as usual |
Primary outcome
Change in female sexual function index (FSFI) (Rosen et al. 2000)
Time frame: Baseline, 6 and 12 months follow up
A multidimensional scale assessing key dimensions of female sexual function. The FSFI is a 19-item self-report questionnaire designed to measure sexual functioning in women. It assesses six domains of sexual function: sexual desire, sexual arousal, lubrication, orgasm, satisfaction, and pain (i.e., pain associated with vaginal penetration). Higher scores indicate better sexual functioning.
10 secondary outcomes
Change in Participant Perceived Improvement (PGIC) (Dworkin et al. 2005)
Time frame: 6 and 12 months follow up
Change in the tampon test (Foster et al. 2009)
Time frame: Baseline, 6 and 12 months follow up
Change in recalled pain intensity during intercourse
Time frame: Baseline, 6 and 12 months follow up
Change in Vulvar Pain Assessment Questionnaire (VPAQ) (Dargie et al. 2017) - life interference
Time frame: Baseline, 6 and 12 months follow up
Change in Vulvar Pain Assessment Questionnaire (VPAQ) (Dargie et al. 2017) - coping strategies
Time frame: Baseline, 6 and 12 months follow up
Change in vulvodynia related self-efficacy
Time frame: Baseline, 6 and 12 months follow up
Change in pain catastrophizing scale (Fernandes et al. 2012)
Time frame: Baseline, 6 and 12 months follow up
Change in Rumination Response Scale (RRS-10) (Parola et al. 2017)
Time frame: Baseline, 6 and 12 months follow up
Change in Hopkins Symptoms Check List (HSCL-25) (Derogatis et al.1974)
Time frame: Baseline, 6 and 12 months follow up
Change in EQ-5D-5L (Herdman et al. 2011)
Time frame: Baseline, 6 and 12 months follow up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2022.
- Background: PubMed 10782451Rosen R, Brown C, Heiman J, Leiblum S, Meston C, Shabsigh R, Ferguson D, D'Agostino R Jr. The Female Sexual Function Index (FSFI): a multidimensional self-report instrument for the assessment of female sexual function. J Sex Marital Ther. 2000 Apr-Jun;26(2):191-208. doi: 10.1080/009262300278597.
- Background: PubMed 15621359Dworkin RH, Turk DC, Farrar JT, Haythornthwaite JA, Jensen MP, Katz NP, Kerns RD, Stucki G, Allen RR, Bellamy N, Carr DB, Chandler J, Cowan P, Dionne R, Galer BS, Hertz S, Jadad AR, Kramer LD, Manning DC, Martin S, McCormick CG, McDermott MP, McGrath P, Quessy S, Rappaport BA, Robbins W, Robinson JP, Rothman M, Royal MA, Simon L, Stauffer JW, Stein W, Tollett J, Wernicke J, Witter J; IMMPACT. Core outcome measures for chronic pain clinical trials: IMMPACT recommendations. Pain. 2005 Jan;113(1-2):9-19. doi: 10.1016/j.pain.2004.09.012. No abstract available.
- Background: PubMed 19305326Foster DC, Beth Kotok M, Huang LS, Watts A, Oakes D, Howard FM, Stodgell CJ, Dworkin RH. The tampon test for vulvodynia treatment outcomes research: reliability, construct validity, and responsiveness. Obstet Gynecol. 2009 Apr;113(4):825-832. doi: 10.1097/AOG.0b013e31819bda7c.
- Background: PubMed 29198513Dargie E, Holden RR, Pukall CF. The Vulvar Pain Assessment Questionnaire: Factor Structure, Preliminary Norms, Internal Consistency, and Test-Retest Reliability. J Sex Med. 2017 Dec;14(12):1585-1596. doi: 10.1016/j.jsxm.2017.10.072.
- Background: PubMed 22726668Fernandes L, Storheim K, Lochting I, Grotle M. Cross-cultural adaptation and validation of the Norwegian pain catastrophizing scale in patients with low back pain. BMC Musculoskelet Disord. 2012 Jun 22;13:111. doi: 10.1186/1471-2474-13-111.
- Background: PubMed 28553085Parola N, Zendjidjian XY, Alessandrini M, Baumstarck K, Loundou A, Fond G, Berna F, Lancon C, Auquier P, Boyer L. Psychometric properties of the Ruminative Response Scale-short form in a clinical sample of patients with major depressive disorder. Patient Prefer Adherence. 2017 May 12;11:929-937. doi: 10.2147/PPA.S125730. eCollection 2017.
- Background: PubMed 4808738Derogatis LR, Lipman RS, Rickels K, Uhlenhuth EH, Covi L. The Hopkins Symptom Checklist (HSCL): a self-report symptom inventory. Behav Sci. 1974 Jan;19(1):1-15. doi: 10.1002/bs.3830190102. No abstract available.
- Background: PubMed 21479777Herdman M, Gudex C, Lloyd A, Janssen M, Kind P, Parkin D, Bonsel G, Badia X. Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L). Qual Life Res. 2011 Dec;20(10):1727-36. doi: 10.1007/s11136-011-9903-x. Epub 2011 Apr 9.
- Background: PubMed 31812684Rosen NO, Bergeron S, Pukall CF. Recommendations for the Study of Vulvar Pain in Women, Part 1: Review of Assessment Tools. J Sex Med. 2020 Feb;17(2):180-194. doi: 10.1016/j.jsxm.2019.10.023. Epub 2019 Dec 4.
- Individual participant dataSharing planned: No
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.
Slawomir Wojniusz, Phd principal investigator
Oslo Metropolitan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Somatocognitive physiotherapy and Treatment as usual in people with Vulvodynia and Vestibulodynia, run by Oslo Metropolitan University 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 4 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: status not confirmed, as of the sponsor's last update on 21 Sep 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Slawomir Wojniusz, Phd (+47 419 26 564, slawomir@oslomet.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in female sexual function index (FSFI) (Rosen et al. 2000) (time frame: Baseline, 6 and 12 months follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04613713, which also lists 9 linked publications.
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 21 Sep 2022.