Physical Therapy as Adjuvant Treatment of Vulvodynia: a Randomized Controled Trial

NCT02871661 | Unknown Phase 3 DMC

• 1 other identifier: State University of Campinas
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

INTRODUCTION: Vulvodynia (chronic vulvar pain in the absence of clinical findings) has a negative impact over quality of life in women with this diagnose. The existing treatments, however, are manifold but insufficient. This study aims to verify the effectiveness of kinesiotherapy and electrotherapy as adjuvant methods in the treatment of vulvodynia. METHODS: A single-blind randomized controlled trial will examine 58 women, divided into three treatment arms: use of tricyclic antidepressant alone (hydrochloride Amitriptyline), amitriptyline hydrochloride associated with pelvic floor muscle exercises and amitriptyline hydrochloride associated with electrotherapy (interferential current). Exclusion criteria are: presence of infections or genital cancers, chronic degenerative diseases; younger than 18 years, neurological disease that jeopardizes the contraction of the muscles of the pelvic floor, taking antidepressant drugs that have interaction with amitriptyline hydrochloride and being pacemakers use. The parameters analyzed before and after treatment will be: muscle volume of the anus elevator and perfusion of the pudendal artery obtained with 3D ultrasound, subjective pain in vaginal intercourse (visual analog scale), monthly frequency of vaginal intercourse, pain referred within vulvar touch on physical examination (swab test from zero to 10) and female sexual function (Female Sexual Function questionnaire - FSFI). There will be a follow up of subjective pain in vaginal intercourse and monthly frequency of vaginal intercourse obtained by telephone contact with the voluntary on one, six and twelve months after the end of interventions. The data will be analyzed using Chi-square test of Pearson, Fisher exact and Mann-Whitney. The beginning and end of treatment will be compared using the Wilcoxon test (related samples) and McNemar (effect of the intervention), considering statistical significance level of 5%. The software used is the statistical analysis software (SAS) - Release 9.1, SAS Institute, Cary, North Carolina, USA, 2002-2003 and Statistical Package for the Social Sciences (SPSS) -Release 17.0.

Conditions

Vulvodynia

Keywords

vulvodynia; pelvic floor muscles; kinesiotherapy; electrical therapy; physical therapy; amitriptyline; female sexual dysfunction.

Outcome Measures

Primary Outcomes (1)

• Pain Scale Measurement

  Effectiveness of the treatment for vulvodynia will be accessed through pain score scale from zero to ten, compared from day zero of treatment to day eight

  Eight weeks

Secondary Outcomes (2)

• Female Sexual Index Function Improvement

  Eight weeks

• 3D Ultrasound measurement of Pelvic Floor Muscle thickness and pudendal artery flow

  Eight weeks

Other Outcomes (1)

• Interleukin 1-B Vaginal Inflammatory response

  Eight weeks

Study Arms (3)

Amitriptyline

ACTIVE COMPARATOR

This group will be treated with medication alone (amitriptyline hydrochloride, 25 mg) for chronic vulvar pain (vulvodynia).

Drug: Amitriptyline

Amitriptyline plus kinesiotherapy

ACTIVE COMPARATOR

This group will be treated with medication (amitriptyline hydrochloride, 25 mg) plus pelvic floor exercises such as Kegel contractions and stretching of pelvic floor muscles with patients own hands.

Drug: Amitriptyline; Other: Kinesiotherapy

Amitriptyline plus IC (Quark)

ACTIVE COMPARATOR

This group will be treated with medication (amitriptyline hydrochloride, 25 mg) plus electrical stimulation with Interferential Current (manufacturer: Quark Medical; Model: Dualpex 961 - program number 42): two electrodes put into the perineal surface area emitting interferential current, once a week for twenty minutes each, for eight weeks long.

Drug: Amitriptyline; Device: IC (Quark)

Interventions

Amitriptyline DRUG

Volunteers will take 25 milligrams of this medication every day from their enrollment until completing eight weeks long.

Also known as: Amitriptyline hydrochloride

Amitriptyline; Amitriptyline plus IC (Quark); Amitriptyline plus kinesiotherapy

Kinesiotherapy OTHER

Volunteers will be taught to contract their pelvic floor muscles right before stretching it, following a home protocol, every day for eight weeks long.

Also known as: Kegel exercises plus muscle stretch

Amitriptyline plus kinesiotherapy

IC (Quark) DEVICE

Volunteers will visit physical therapy clinic once a week to receive twenty minutes of electrical stimulation with Interferential Current (Duapex 961 of Quark Medical manufacturer) in their perineal area, for eight weeks long.

Also known as: interferential current, Dualpex 961 - Quark

Amitriptyline plus IC (Quark)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Having had previous vaginal penetration
• Accept to perform kinesiotherapy sessions or electrical therapy once a week for two months
• Accept using medication (Amitriptyline hydrochloride) during the treatment period

You may not qualify if:

• Being pregnant
• Using drugs that negatively interfere with the hydrochloride Amtriptilina (ANNEX II)
• Having cognitive or literacy difficulties that prevent the understanding of self answered questionnaires such Female Sexual Function Index (FSFI).
• Refusing to sign the Informed Consent
• Neuromuscular disorders that interfere on the proper contraction of the pelvic floor muscles
• Having decompensated chronic degenerative diseases (tuberculosis, AIDS, hepatitis, diabetes, etc.)
• Using pacemaker or having cardiac arrhythmia
• Taking antidepressant monoamine oxidase inhibitor (MAOI) or Ayahuasca tea

Sponsors & Collaborators

• University of Campinas, Brazil: lead

Study Sites (1)

Unicamp

Campinas, São Paulo, 13083-970, Brazil

RECRUITING

Related Publications (6)

• Goldstein AT, Pukall CF, Brown C, Bergeron S, Stein A, Kellogg-Spadt S. Vulvodynia: Assessment and Treatment. J Sex Med. 2016 Apr;13(4):572-90. doi: 10.1016/j.jsxm.2016.01.020. Epub 2016 Mar 25.

  PMID: 27045258 RESULT

• Reed BD, Caron AM, Gorenflo DW, Haefner HK. Treatment of vulvodynia with tricyclic antidepressants: efficacy and associated factors. J Low Genit Tract Dis. 2006 Oct;10(4):245-51. doi: 10.1097/01.lgt.0000225899.75207.0a.

  PMID: 17012991 RESULT

• Correa JB, Costa LO, Oliveira NT, Lima WP, Sluka KA, Liebano RE. Effects of the carrier frequency of interferential current on pain modulation and central hypersensitivity in people with chronic nonspecific low back pain: A randomized placebo-controlled trial. Eur J Pain. 2016 Nov;20(10):1653-1666. doi: 10.1002/ejp.889. Epub 2016 May 6.

  PMID: 27150263 RESULT

• Gentilcore-Saulnier E, McLean L, Goldfinger C, Pukall CF, Chamberlain S. Pelvic floor muscle assessment outcomes in women with and without provoked vestibulodynia and the impact of a physical therapy program. J Sex Med. 2010 Feb;7(2 Pt 2):1003-22. doi: 10.1111/j.1743-6109.2009.01642.x. Epub 2010 Jan 6.

  PMID: 20059663 RESULT

• Dionisi B, Anglana F, Inghirami P, Lippa P, Senatori R. [Use of transcutaneous electrical stimulation and biofeedback for the treatment of vulvodynia (vulvar vestibular syndrome): result of 3 years of experience]. Minerva Ginecol. 2008 Dec;60(6):485-91. Italian.

  PMID: 18981976 RESULT

• Bardin MG, Giraldo PC, Fante JF, Carvalho de Araujo C, Cyr MP, Marques AA. Current Practices in Brazil on Diagnosis and Management of Women With Vulvodynia. J Low Genit Tract Dis. 2023 Apr 1;27(2):173-179. doi: 10.1097/LGT.0000000000000695. Epub 2023 Mar 3.

  PMID: 36951987 DERIVED

MeSH Terms

Conditions

Vulvodynia

Interventions

Amitriptyline

Condition Hierarchy (Ancestors)

Vulvar Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Dibenzocycloheptenes; Benzocycloheptenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Officials

• Paulo C Giraldo, MD, PhD

  University of Campinas, Brazil

  STUDY DIRECTOR

• Marcela G Bardin, PT, Master

  University of Campinas, Brazil

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marcela G Bardin, Master

CONTACT

5519981548688; mabardin@yahoo.com.br

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Master in Obstetrics and Gynecology

Study Record Dates

• First Submitted: July 19, 2016
• First Posted: August 18, 2016
• Study Start: July 1, 2016
• Primary Completion: October 1, 2017
• Study Completion: December 1, 2017
• Last Updated: August 18, 2016

Record last verified: 2016-07

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)