Back to resultsTHE EFFECT OF tDCS IN THE TREATMENT OF CHRONIC PELVIC PAIN ASSOCIATED WITH ENDOMETRIOSIS (tDCS)
Primary Purpose
Chronic Pain, Endometriosis
Status
Unknown status
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
transcranial direct current stimulation (tDCS)
Sham Transcranial Direct Current Stimulation
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Pain focused on measuring Endometriosis, Transcranial Direct Current Stimulation, tDCS, Near Infrared Spectroscopy, NIRS, Chronic Pelvic Pain
Eligibility 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.
Sites / Locations
- Hospital de Clínicas de Porto Alegre
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Active tDCS
tDCS Sham
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Change in worst daily pain assessed with the visual analogue scale.
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.
Changes in motor cortex blood flow assessed by near infrared spectroscopy
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.
Change in Functional Pain Scale
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.
Change in the temperature pain threshold
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).
Change in effect of the descendent modulator system of pain
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
Change in serum biomarkers level: The brain derived neurotrophic factor (BDNF) and interleukins
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
Full Information
NCT ID
NCT02161302
First Posted
June 10, 2014
Last Updated
June 10, 2014
Sponsor
Hospital de Clinicas de Porto Alegre
1. Study Identification
Unique Protocol Identification Number
NCT02161302
Brief Title
THE EFFECT OF tDCS IN THE TREATMENT OF CHRONIC PELVIC PAIN ASSOCIATED WITH ENDOMETRIOSIS
Acronym
tDCS
Official Title
THE EFFECT OF TRANSCRANIAL DIRECT CURRENT STIMULATION (tDCS) IN THE TREATMENT OF CHRONIC PELVIC PAIN ASSOCIATED WITH ENDOMETRIOSIS
Study Type
Interventional
2. Study Status
Record Verification Date
June 2014
Overall Recruitment Status
Unknown status
Study Start Date
June 2014 (undefined)
Primary Completion Date
May 2015 (Anticipated)
Study Completion Date
May 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital de Clinicas de Porto Alegre
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain, Endometriosis
Keywords
Endometriosis, Transcranial Direct Current Stimulation, tDCS, Near Infrared Spectroscopy, NIRS, Chronic Pelvic Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Active tDCS
Arm Type
Experimental
Arm Description
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.
Arm Title
tDCS Sham
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
transcranial direct current stimulation (tDCS)
Other Intervention Name(s)
tDCS
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Sham Transcranial Direct Current Stimulation
Other Intervention Name(s)
Sham tDCS
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in worst daily pain assessed with the visual analogue scale.
Description
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.
Time Frame
Once Daily. Start 7 days before treatment, everyday during treatment period and every day during follow-up period (total = 35 days)
Title
Changes in motor cortex blood flow assessed by near infrared spectroscopy
Description
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.
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)
Title
Change in Functional Pain Scale
Description
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.
Time Frame
Once a week - Treatment Day 1, Day 8, Day 15, Day 22, Day 29
Title
Change in the temperature pain threshold
Description
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).
Time Frame
up to Day 29
Title
Change in effect of the descendent modulator system of pain
Description
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.
Time Frame
up to Day 29
Secondary Outcome Measure Information:
Title
Change in serum biomarkers level: The brain derived neurotrophic factor (BDNF) and interleukins
Description
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
Time Frame
up to Day 29
Other Pre-specified Outcome Measures:
Title
Depressive symptoms level
Description
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.
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)
Title
Anxiety level
Description
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.
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)
Title
Psychiatric diseases
Description
Psychiatric diseases will be evaluated by the Structured Clinical Interview for DSM-IV (SCID) in the patient screening. Total = 1 evaluation
Time Frame
1day on patient screening
Title
Estradiol level
Description
Estradiol blood level will be measured on treatment Day 1 (before receiving the 1st session of tDCS). Total = 1 evaluation
Time Frame
Treatment Day 1 (before receiving the 1st session of tDCS)
Title
Adverse Effects
Description
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
Time Frame
up to Day 29
Title
Pain catastrophizing thoughts
Description
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
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)
Title
Demographic data and comorbidities
Description
Demographic data and comorbidities will be asked in the baseline (before the first session of tDCS). Total = 1 evaluation.
Time Frame
Baseline
Title
Change in quality of life
Description
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
Time Frame
Baseline and Day 15
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wolnei Caumo, MD, PhD
Phone
51 3359 8083
Email
caumo@cpovo.net
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wolnei Caumo, MD, PhD
Organizational Affiliation
Hospital de Clínicas de Porto Alegre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital de Clínicas de Porto Alegre
City
Porto Alegre
State/Province
Rio Grande do Sul
ZIP/Postal Code
90035-903
Country
Brazil
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wolnei Caumo, MD, PhD
Phone
(51) 3359 8083
Email
caumo@cpovo.net
First Name & Middle Initial & Last Name & Degree
Wolnei Caumo, MD, PhD
12. IPD Sharing Statement
Citations:
PubMed Identifier
21170277
Citation
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Results Reference
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PubMed Identifier
20945016
Citation
Nacul AP, Spritzer PM. [Current aspects on diagnosis and treatment of endometriosis]. Rev Bras Ginecol Obstet. 2010 Jun;32(6):298-307. doi: 10.1590/s0100-72032010000600008. Portuguese.
Results Reference
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PubMed Identifier
18312584
Citation
Boros K, Poreisz C, Munchau A, Paulus W, Nitsche MA. Premotor transcranial direct current stimulation (tDCS) affects primary motor excitability in humans. Eur J Neurosci. 2008 Mar;27(5):1292-300. doi: 10.1111/j.1460-9568.2008.06090.x. Epub 2008 Feb 29.
Results Reference
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PubMed Identifier
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Citation
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Results Reference
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THE EFFECT OF tDCS IN THE TREATMENT OF CHRONIC PELVIC PAIN ASSOCIATED WITH ENDOMETRIOSIS
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