Effectiveness of Cognitive Behavioural Therapy and Physical Therapy for Provoked Vestibulodynia

Vulvar Vestibulitis Clinical Trial

Official title:

A Randomized Comparison of Individual Cognitive-behavioural Therapy and Pelvic Floor Rehabilitation in the Treatment of Provoked Vestibulodynia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02494934
• Other study ID #: 379631
• Status: Completed
• Phase: N/A
• First received: June 30, 2015
• Last updated: August 30, 2015
• Start date: September 2009
• Est. completion date: April 2012

Study information

• Verified date: August 2015
• Source: Queen's University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Canadian Institutes of Health Research
• Study type: Interventional

Clinical Trial Summary

The purpose of the study was to compare the effectiveness of cognitive behavioural therapy (CBT) and physical therapy (PT) on pain and psychosexual outcomes in women with provoked vestibulodynia (PVD).

Description:

Provoked vestibulodynia (PVD) is the most common condition leading to painful intercourse and is currently best understood within a biopsychosocial framework. Although the usefulness of non-medical treatment options for vulvar pain is recognized by many, there is limited research investigating the effectiveness of these treatments using a biopsychosocial approach to outcome measurement. Furthermore, there is little evidence to support the mechanisms by which these treatments lead to pain reduction. This study aimed to address these gaps by investigating two non-medical treatment options: individual cognitive-behavioural therapy (CBT) and physical therapy (PT).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• fluent in English

• vulvar pain with attempted vaginal penetration for at least 6 months

• pain limited to vulvar vestibule during cotton swab test

Exclusion Criteria:

• other serious medical, psychiatric, or other pain conditions

• generalized vulvodynia and/or significant vaginismus (i.e., not able to have at least one finger inserted vaginally)

• current pregnancy, breastfeeding, or being less than 6 months postpartum

• unwillingness to abstain from other treatments for their PVD pain during the course of the study

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Vulvar Vestibulitis

Intervention

Behavioral:
• cognitive-behavioural therapy
The CBT program was adapted from a previously used group CBT program and included the following procedures: (1) education about PVD; (2) collaborative re-conceptualization of PVD as a multi-factorial pain condition; (3) desensitization exercises; (4) diaphragmatic breathing and other relaxation techniques; (5) discussion about and techniques for increasing sexual desire and arousal; (6) sexual communication skills training; (7) instructions on carrying out PFM exercises; (8) instructions on the use of silicone vaginal dilators to do progressive vaginal penetration activities at home; and (9) informal and formal cognitive restructuring techniques and the use of coping self-statements.
• physical therapy
The PT treatment protocol included the following procedures: (1) education about PVD; (2) targeted PFM exercises focused on contraction and relaxation including in-session practice and feedback; (3) manual techniques; (4) surface electromyographic biofeedback (sEMG); (5) progressive vaginal penetration activities through the use of four silicone vaginal dilators of varied diameter; (6) stretches of the hip muscles; (7) deep breathing and global body relaxation exercises; and (8) additional methods of managing pain and counseling about different sexual positions.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Queen's University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change from baseline in pain with sexual intercourse at 12 weeks	measured on an 11-point numerical rating scale	Baseline, 12 weeks	No