Somatocognitive Therapy in Treatment of Provoked (Localized) Vestibulodynia - Randomized Clinical Trial (ProLoVe Study)

NCT04613713 | Unknown

• 1 other identifier: 29295
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Vulvodynia; Vestibulodynia

Keywords

Provoked vestibulodynia; Dyspareunia; Somatocognitive therapy; Physiotherapy; Randomised clinical trial; Women's health; Sexual dysfunction; Pain management

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline, 6 and 12 months follow up

Secondary Outcomes (10)

• Change in Participant Perceived Improvement (PGIC) (Dworkin et al. 2005)

  6 and 12 months follow up

• Change in the tampon test (Foster et al. 2009)

  Baseline, 6 and 12 months follow up

• Change in recalled pain intensity during intercourse

  Baseline, 6 and 12 months follow up

• Change in Vulvar Pain Assessment Questionnaire (VPAQ) (Dargie et al. 2017) - life interference

  Baseline, 6 and 12 months follow up

• Change in Vulvar Pain Assessment Questionnaire (VPAQ) (Dargie et al. 2017) - coping strategies

  Baseline, 6 and 12 months follow up

Study Arms (2)

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)

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.

Other: Treatment as usual

Interventions

Somatocognitive physiotherapy OTHER

The 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.

Somatocognitive physiotherapy

Treatment as usual OTHER

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.

Treatment as usual

Eligibility Criteria

• Age: 18 Years - 35 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Oslo Metropolitan University: lead

Study Sites (1)

Oslo Metropolitan University

Oslo, 0130, Norway

RECRUITING

Related Publications (9)

• 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.

  PMID: 10782451 BACKGROUND

• Dworkin 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.

  PMID: 15621359 BACKGROUND

• Foster 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.

  PMID: 19305326 BACKGROUND

• Dargie 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.

  PMID: 29198513 BACKGROUND

• Fernandes 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.

  PMID: 22726668 BACKGROUND

• Parola 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.

  PMID: 28553085 BACKGROUND

• Derogatis 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.

  PMID: 4808738 BACKGROUND

• Herdman 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.

  PMID: 21479777 BACKGROUND

• Rosen 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.

  PMID: 31812684 BACKGROUND

MeSH Terms

Conditions

Vulvodynia; Dyspareunia; Sexual Dysfunction, Physiological; Agnosia

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Vulvar Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Male; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Slawomir Wojniusz, Phd

  Oslo Metropolitan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Slawomir Wojniusz, Phd

CONTACT

+47 419 26 564; slawomir@oslomet.no

Mette B Kaarbø, Msc

CONTACT

+47 974 11 669; metteboy@oslomet.no

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Statistician analyzing the data will be blinded for group belonging
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Parallel group randomized clinical trial

Study Record Dates

• First Submitted: October 26, 2020
• First Posted: November 3, 2020
• Study Start: January 1, 2021
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: September 21, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)