Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

THE EFFECT OF tDCS IN THE TREATMENT OF CHRONIC PELVIC PAIN ASSOCIATED WITH ENDOMETRIOSIS (tDCS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02161302
Recruitment Status : Unknown
Verified June 2014 by Hospital de Clinicas de Porto Alegre.
Recruitment status was:  Not yet recruiting
First Posted : June 11, 2014
Last Update Posted : June 11, 2014
Sponsor:
Information provided by (Responsible Party):
Hospital de Clinicas de Porto Alegre

Brief Summary:
The purpose of this study is to determine if transcranial direct current stimulation (tDCS) is effective in the treatment of chronic pelvic pain associated with endometriosis

Condition or disease Intervention/treatment Phase
Chronic Pain Endometriosis Device: transcranial direct current stimulation (tDCS) Device: Sham Transcranial Direct Current Stimulation Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: THE EFFECT OF TRANSCRANIAL DIRECT CURRENT STIMULATION (tDCS) IN THE TREATMENT OF CHRONIC PELVIC PAIN ASSOCIATED WITH ENDOMETRIOSIS
Study Start Date : June 2014
Estimated Primary Completion Date : May 2015
Estimated Study Completion Date : May 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Active tDCS
tDCS will be applied in the head of the patients in 20 minute sessions, daily from Monday to Friday for 2 weeks (10 sessions total). The stimulation will be administered with a pair of surface electrodes, sponge coated, soaked in saline. A battery-powered constant current stimulator will be used for this purpose (tDCS device Soterix 1X1). The stimulation is performed by placing the anodal electrode in the primary motor cortex (M1) and the cathodal one in the contralateral supraorbital area, and it will use a 2 mA current.
Device: transcranial direct current stimulation (tDCS)
The stimulation will be administered with a pair of surface electrodes, sponge coated, soaked in saline. A battery-powered constant current stimulator will be used for this purpose (tDCS device Soterix 1X1). The stimulation is performed by placing the anodal electrode in the primary motor cortex (M1) and the cathodal one in the contralateral supraorbital area and it will use a 2 mA current.
Other Name: tDCS

Sham Comparator: tDCS Sham
The sham tDCS consists of the same montage of the active tDCS, but the device is turned off 30 seconds after initiating stimulation (without letting the patient notice it). Rest of the montage is kept identical as the active one during the 20 minutes that the session lasts.
Device: Sham Transcranial Direct Current Stimulation
The sham tDCS consists of the same montage of the active tDCS, but the device is turned off 30 seconds after initiating stimulation (without letting the patient notice it). Rest of the montage is kept identical as the active one during the 20 minutes that the session lasts.
Other Name: Sham tDCS




Primary Outcome Measures :
  1. Change in worst daily pain assessed with the visual analogue scale. [ Time Frame: Once Daily. Start 7 days before treatment, everyday during treatment period and every day during follow-up period (total = 35 days) ]
    Patients will be asked to daily write down their worst pain level (assessed by the Visual Analogue Scale, self-administered) in a paper diary with different scores: global pain, pain during menses, pain during sexual intercourse, pain during urination, pain during defecation. They will also be asked to daily write the analgesic drug intake. Total evaluations: 35 days.

  2. Changes in motor cortex blood flow assessed by near infrared spectroscopy [ Time Frame: Treatment Day 1 (before receiving the 1st session of tDCS); Day 15 (at the end of treatment period) and Day 29 (at the end of follow-up period) ]
    Motor cortex blood flow will be assessed before the first session of tDCS (on Treatment day 1), after the end of treatment period (Day 15) and after the follow-up period (Day 29). Total = 3 evaluations.

  3. Change in Functional Pain Scale [ Time Frame: Once a week - Treatment Day 1, Day 8, Day 15, Day 22, Day 29 ]
    Functional Pain Scale will be assessed by the Brazilian Profile of Chronic Pain: Screen (B-PCP:S) once a week, as folow: On the Treatment Day 1 (before the first session of tDCS - considered baseline), on Treatment Day 8, Day 15, Day 22 and Day 29. Total = 5 evaluations.

  4. Change in the temperature pain threshold [ Time Frame: up to Day 29 ]
    It will be assessed by the Quantitative Sensory Test (QST) in the dominant (right) forearm. The heat pain tolerance and pain threshold to the heat and the temperature defined as pain 6/10 by the participant. The temperature starts at 32°C, and it heat at a 1.0 °C/sec rate and cools down after a button is pressed or whenever it reaches the max temperature of 52°C. The participant will be asked to press the button at the first sensation of pain to determine the pain threshold; to press the button whenever she can not stand the heat anymore for the pain tolerance determination and, for last, to press the button at the temperature she fells pain equivalent to 6/10 in the numeric scale of pain. The pain threshold and the temperature of pain 6/10 will be determined by the arithmetic mean of 3 evaluations each. Total of 3 test days: Day 1 (before the first session of tDCS), after the end of the Treatment period (Day 15) and at the end of the follow-up period (Day 29).

  5. Change in effect of the descendent modulator system of pain [ Time Frame: up to Day 29 ]
    It will be assessed by the Conditioned Pain Modulation test (CPM). A nociceptive tonic conditioning stimulus - immersion of the non-dominant hand in cold water (0°C for 1 minute) - will be applied concomitant to the progressive thermal stimulus in the dominant forearm as applied in the QST pattern until it reaches the 6/10 pain temperature previously determined by the participant. It will be tested in Treatment Day 1 (before the first session of tDCS - considered baseline), after the end of the Treatment period (Day 15) and at the end of the follow-up period (Day 29) - Total = 3 evaluation.


Secondary Outcome Measures :
  1. Change in serum biomarkers level: The brain derived neurotrophic factor (BDNF) and interleukins [ Time Frame: up to Day 29 ]
    A blood sample will be colected to measure BDNF and interleukins on Treatment Day 1 (right before the first tDCS session - considered baseline), after the end of the treatment period (day 15) and after the end of the follow-up period (day 29). Total = 3 evaluations


Other Outcome Measures:
  1. Depressive symptoms level [ Time Frame: Treatment Day 1 (before receiving the 1st session of tDCS); Day 15 (at the end of treatment period) and Day 29 (at the end of follow-up period) ]
    Depression symptoms will be assessed by using the Beck II Inventory. It will be assessed before the first session of tDCS (on Treatment day 1), after the end of treatment period (Day 15) and after the follow-up period (Day 29). Total = 3 evaluations.

  2. Anxiety level [ Time Frame: Treatment Day 1 (before receiving the 1st session of tDCS); Day 15 (at the end of treatment period) and Day 29 (at the end of follow-up period) ]
    Anxiety level will be assessed by State-Trait Anxiety Inventory (STAI), adapted to Brazilian Portuguese Language. It will be assessed before the first session of tDCS (on Treatment day 1), after the end of treatment period (Day 15) and after the follow-up period (Day 29). Total = 3 evaluations.

  3. Psychiatric diseases [ Time Frame: 1day on patient screening ]
    Psychiatric diseases will be evaluated by the Structured Clinical Interview for DSM-IV (SCID) in the patient screening. Total = 1 evaluation

  4. Estradiol level [ Time Frame: Treatment Day 1 (before receiving the 1st session of tDCS) ]
    Estradiol blood level will be measured on treatment Day 1 (before receiving the 1st session of tDCS). Total = 1 evaluation

  5. Adverse Effects [ Time Frame: up to Day 29 ]
    At the end of each tDCS session, the incidence of any adverse effects - paresthesia, headache, dizziness, nausea, neck pain, burns, redness or pain in the scalp, insomnia, abrupt humor changes and lack of concentration - will be questioned to the participant. Total = 10 evaluations

  6. Pain catastrophizing thoughts [ Time Frame: Treatment Day 1 (before receiving the 1st session of tDCS); Day 15 (at the end of treatment period) and Day 29 (at the end of follow-up period) ]
    The level of catastrophic thinking will be assessed by the Pain Catastrophizing Scale on Treatment Day 1 (before receiving the 1st session of tDCS), after the treatment period (Day 15) and at the end of the follow-up period (Day29). Total = 3 evaluations

  7. Demographic data and comorbidities [ Time Frame: Baseline ]
    Demographic data and comorbidities will be asked in the baseline (before the first session of tDCS). Total = 1 evaluation.

  8. Change in quality of life [ Time Frame: Baseline and Day 15 ]
    Quality of life will be assessed by the WHOQOL (World Health Organization Quality of Life), in Treatment Day 1 (before the first session of tDCS - considered baseline) and after the treatment period (Day 15). Total = 2 evaluations



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age > 18 years old, non-menopausic, with the diagnosis of endometriosis by videolaparoscopy and biopsy, able to understand and write the Portuguese language, in treatment with isolated progestin for at least one month, that have worst daily pain in the analogue visual scale > 4 cm in most of the days in the last month

Exclusion Criteria:

  • left-handed women, endometriosis implantation in intestine, bladder or urether (surgical treatment indication), history of intense or frequent headache, chronic dermatologic disease, previous adverse effects to treatment with tDCS, seizures, severe cranial trauma with alteration of the cranial anatomy, metallic intracranial implants or pacemaker, history of pelvic inflammatory disease, non-compensated psychiatric disease, non-collaborative patients, history of neurologic, oncologic disease, heart, renal or hepatic failure.

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): NCT02161302


Contacts
Layout table for location contacts
Contact: Wolnei Caumo, MD, PhD 51 3359 8083 caumo@cpovo.net

Locations
Layout table for location information
Brazil
Hospital de Clínicas de Porto Alegre Not yet recruiting
Porto Alegre, Rio Grande do Sul, Brazil, 90035-903
Contact: Wolnei Caumo, MD, PhD    (51) 3359 8083    caumo@cpovo.net   
Principal Investigator: Wolnei Caumo, MD, PhD         
Sponsors and Collaborators
Hospital de Clinicas de Porto Alegre
Investigators
Layout table for investigator information
Principal Investigator: Wolnei Caumo, MD, PhD Hospital de Clínicas de Porto Alegre

Publications:

Layout table for additonal information
Responsible Party: Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier: NCT02161302     History of Changes
Other Study ID Numbers: 14-0092
First Posted: June 11, 2014    Key Record Dates
Last Update Posted: June 11, 2014
Last Verified: June 2014

Keywords provided by Hospital de Clinicas de Porto Alegre:
Endometriosis
Transcranial Direct Current Stimulation
tDCS
Near Infrared Spectroscopy
NIRS
Chronic Pelvic Pain

Additional relevant MeSH terms:
Layout table for MeSH terms
Chronic Pain
Endometriosis
Pelvic Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Genital Diseases, Female