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Trial record 43 of 135 for:    AMITRIPTYLINE

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

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ClinicalTrials.gov Identifier: NCT02871661
Recruitment Status : Unknown
Verified July 2016 by Marcela Grigol Bardin, University of Campinas, Brazil.
Recruitment status was:  Recruiting
First Posted : August 18, 2016
Last Update Posted : August 18, 2016
Sponsor:
Information provided by (Responsible Party):
Marcela Grigol Bardin, University of Campinas, Brazil

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.

Condition or disease Intervention/treatment Phase
Vulvodynia Drug: Amitriptyline Other: Kinesiotherapy Device: IC (Quark) Phase 3

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 58 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Physical Therapy as Adjuvant Treatment of Vulvodynia: a Randomized Controled Trial
Study Start Date : July 2016
Estimated Primary Completion Date : October 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Amitriptyline
This group will be treated with medication alone (amitriptyline hydrochloride, 25 mg) for chronic vulvar pain (vulvodynia).
Drug: Amitriptyline
Volunteers will take 25 milligrams of this medication every day from their enrollment until completing eight weeks long.
Other Name: Amitriptyline hydrochloride

Active Comparator: Amitriptyline plus kinesiotherapy
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
Volunteers will take 25 milligrams of this medication every day from their enrollment until completing eight weeks long.
Other Name: Amitriptyline hydrochloride

Other: Kinesiotherapy
Volunteers will be taught to contract their pelvic floor muscles right before stretching it, following a home protocol, every day for eight weeks long.
Other Name: Kegel exercises plus muscle stretch

Active Comparator: Amitriptyline plus IC (Quark)
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
Volunteers will take 25 milligrams of this medication every day from their enrollment until completing eight weeks long.
Other Name: Amitriptyline hydrochloride

Device: IC (Quark)
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.
Other Name: interferential current, Dualpex 961 - Quark




Primary Outcome Measures :
  1. Pain Scale Measurement [ Time Frame: Eight weeks ]
    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


Secondary Outcome Measures :
  1. Female Sexual Index Function Improvement [ Time Frame: Eight weeks ]
    Will be accessed through FSIF (Female Sexual Index Function questionnaire) score that goes from 2 to 36, compared from day zero of treatment to day eight, which indicates sexual disfunction pointed by scores below 26,55.

  2. 3D Ultrasound measurement of Pelvic Floor Muscle thickness and pudendal artery flow [ Time Frame: Eight weeks ]
    A 3D Ultrassound will be used to access these outcomes and compare changes from day zero to day eight of treatment


Other Outcome Measures:
  1. Interleukin 1-B Vaginal Inflammatory response [ Time Frame: Eight weeks ]
    Vaginal fluid collected will be analysed in laboratory to access possible inflammatory response of vulva and vagina of women with vulvodynia obtained by comparing quantitatively interleukin 1-B presente before and after treatment



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02871661


Contacts
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Contact: Marcela G Bardin, Master 5519981548688 mabardin@yahoo.com.br

Locations
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Brazil
Unicamp Recruiting
Campinas, Sao Paulo, Brazil, 13083-970
Contact: Marcela G Bardin, Master    5519981548688    mabardin@yahoo.co.br   
Contact: Paulo c Giraldo, MD, PhD    5519996156466    paulocesargiraldo@gmail.com   
Sponsors and Collaborators
University of Campinas, Brazil
Investigators
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Study Director: Paulo C Giraldo, MD, PhD University of Campinas, Brazil
Principal Investigator: Marcela G Bardin, PT, Master University of Campinas, Brazil

Publications of Results:
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Responsible Party: Marcela Grigol Bardin, Master in Obstetrics and Gynecology, University of Campinas, Brazil
ClinicalTrials.gov Identifier: NCT02871661     History of Changes
Other Study ID Numbers: State University of Campinas
First Posted: August 18, 2016    Key Record Dates
Last Update Posted: August 18, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Marcela Grigol Bardin, University of Campinas, Brazil:
vulvodynia
pelvic floor muscles
kinesiotherapy
electrical therapy
physical therapy
amitriptyline
female sexual dysfunction.
Additional relevant MeSH terms:
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Amitriptyline
Amitriptyline, perphenazine drug combination
Vulvodynia
Vulvar Diseases
Genital Diseases, Female
Antidepressive Agents, Tricyclic
Antidepressive Agents
Psychotropic Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Neurotransmitter Agents
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants