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Somatocognitive Therapy in Treatment of Provoked Vestibulodynia - a Feasibility Study (ProLoVe)

O

Oslo Metropolitan University

Status

Completed

Conditions

Provoked Vestibulodynia

Treatments

Other: somatocognitive physiotherapy

Study type

Interventional

Funder types

Other

Identifiers

NCT04208204
2018/1036

Details and patient eligibility

About

This study examines feasibility of R&D activities in the planned randomized controlled trial where effectiveness of somatocognitive therapy intervention will be compared to treatment as usual in provoked vestibulodynia.

Full description

Provoked vestibulodynia is a multifactorial, persistent pain condition, affecting young women. It represents the most common cause of pain during sexual intercourse. Existing treatment approaches are predominantly based on clinical experience, observational studies, or reports of expert committees. Although, physiotherapy is one of the most commonly recommended treatments, high quality randomized controlled trials are needed to assess its effectiveness.

This is a phase I, feasibility study with the purpose of testing R&D activities for a planned full size RCT. Additionally, patients experiences with the somatocognitive therapy intervention, assessment measures and condition itself will be collected using qualitative interviews. The results will be applied to adjust time-line of the treatment, outcome measures and therapeutic approach before commencing full scale RCT.

Enrollment

10 patients

Sex

Female

Ages

18 to 35 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Confirmed provoked vestibulodynia diagnosis

Exclusion criteria

  • vulvar pain is not clearly linked to intercourse or pressure applied to vestibule or usage of tampon
  • active infection or dermatologic lesion in the vulvar region

Trial design

Primary purpose

Other

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

10 participants in 1 patient group

Somatocognitive physiotherapy
Experimental group
Description:
Every participant will maximally receive 15 individual sessions of somatocognitive physiotherapy
Treatment:
Other: somatocognitive physiotherapy

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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