Chronic PaintDCSNCT02161302

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

A study testing transcranial direct current stimulation (tDCS) in people with Chronic Pain and Endometriosis, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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 Read more about this study

Who is it for?: Ages 18 to 55 years, women only
Conditions the study is for: Chronic Pain, Endometriosis
What is being tested?: transcranial direct current stimulation (tDCS)
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 30 participants
Where: 1 siteBrazil
Study dates: Jun 2014to May 2016
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 55 years
Women only
No healthy volunteers
Adult

Who may be able to join

age > 18 years old, non-menopausal, 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, who have the worst daily pain in the analogue visual scale > 4 cm on most of the days in the last month

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

Brazil1 site

Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035-903

Other trials in Brazil

About this study

Official title: THE EFFECT OF TRANSCRANIAL DIRECT CURRENT STIMULATION (tDCS) IN THE TREATMENT OF CHRONIC PELVIC PAIN ASSOCIATED WITH ENDOMETRIOSIS

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

Conditions: Chronic Pain, Endometriosis
Being tested: transcranial direct current stimulation (tDCS), Sham Transcranial Direct Current Stimulation
Keywords: Endometriosis, Transcranial Direct Current Stimulation, tDCS, Near Infrared Spectroscopy, NIRS, Chronic Pelvic Pain
Medical subject headings: Chronic Pain, Endometriosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

transcranial direct current stimulation (tDCS)Device
Also called 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.
Sham Transcranial Direct Current StimulationDevice
Also called Sham tDCS
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.

Study groups in NCT02161302
Study group	Role	What they receive
Active tDCS	Experimental	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. Receives: Device: transcranial direct current stimulation (tDCS)
tDCS Sham	Sham comparator	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. Receives: Device: Sham Transcranial Direct Current Stimulation

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in worst daily pain assessed with the visual analogue scale.
Patients will be asked to 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.
Measured: Once Daily. Start 7 days before treatment, everyday during treatment period and every day during follow-up period (total = 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.
Measured: 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)
Change in Functional Pain Scale
The Functional Pain Scale will be assessed by the Brazilian Profile of Chronic Pain: Screen (B-PCP:S) once a week, as follows: on 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.
Measured: Once a week - Treatment Day 1, Day 8, Day 15, Day 22, Day 29
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).
Measured: up to 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.
Measured: up to Day 29

Secondary outcomes (1)

Change in serum biomarkers level: The brain derived neurotrophic factor (BDNF) and interleukins
A blood sample will be collected 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
Measured: up to Day 29

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2014May 2016

First posted11 Jun 2014 (estimated)
Study startJun 2014
Primary completionMay 2015
Study completionMay 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (8)Papers the sponsor has linked to this study.
Other trials for Chronic PainStudies of the same condition, open and under way.
More trials run by Hospital de Clinicas de Porto AlegreThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02161302
Sponsor's protocol ID: 14-0092
Acronym: tDCS
Status last verified: Jan 2026
First submitted: 10 Jun 2014
Last updated: 15 Jan 2026
Results posted: No
Data monitoring committee: No

Publications

Valle A, Roizenblatt S, Botte S, Zaghi S, Riberto M, Tufik S, Boggio PS, Fregni F. Efficacy of anodal transcranial direct current stimulation (tDCS) for the treatment of fibromyalgia: results of a randomized, sham-controlled longitudinal clinical trial. J Pain Manag. 2009;2(3):353-361.
PubMed 21170277
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.
PubMed 20945016
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.
PubMed 18312584
Nitsche MA, Liebetanz D, Antal A, Lang N, Tergau F, Paulus W. Modulation of cortical excitability by weak direct current stimulation--technical, safety and functional aspects. Suppl Clin Neurophysiol. 2003;56:255-76. doi: 10.1016/s1567-424x(09)70230-2. No abstract available.
PubMed 14677403
Nitsche MA, Cohen LG, Wassermann EM, Priori A, Lang N, Antal A, Paulus W, Hummel F, Boggio PS, Fregni F, Pascual-Leone A. Transcranial direct current stimulation: State of the art 2008. Brain Stimul. 2008 Jul;1(3):206-23. doi: 10.1016/j.brs.2008.06.004. Epub 2008 Jul 1.
PubMed 20633386
Fenton BW, Palmieri PA, Boggio P, Fanning J, Fregni F. A preliminary study of transcranial direct current stimulation for the treatment of refractory chronic pelvic pain. Brain Stimul. 2009 Apr;2(2):103-7. doi: 10.1016/j.brs.2008.09.009. Epub 2009 Feb 28.
PubMed 20633407
Caumo W, Ruehlman LS, Karoly P, Sehn F, Vidor LP, Dall-Agnol L, Chassot M, Torres IL. Cross-cultural adaptation and validation of the profile of chronic pain: screen for a Brazilian population. Pain Med. 2013 Jan;14(1):52-61. doi: 10.1111/j.1526-4637.2012.01528.x. Epub 2012 Nov 21.
PubMed 23171145
Sehn F, Chachamovich E, Vidor LP, Dall-Agnol L, de Souza IC, Torres IL, Fregni F, Caumo W. Cross-cultural adaptation and validation of the Brazilian Portuguese version of the pain catastrophizing scale. Pain Med. 2012 Nov;13(11):1425-35. doi: 10.1111/j.1526-4637.2012.01492.x. Epub 2012 Oct 4.
PubMed 23036076

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 15 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: THE EFFECT OF TRANSCRANIAL DIRECT CURRENT STIMULATION (tDCS) IN THE TREATMENT OF CHRONIC PELVIC PAIN ASSOCIATED WITH ENDOMETRIOSIS
ClinicalTrials.gov ID: NCT02161302
Acronym / sponsor ID: tDCS / 14-0092
Conditions: Chronic Pain, Endometriosis
Keywords: Endometriosis, Transcranial Direct Current Stimulation, tDCS, Near Infrared Spectroscopy, NIRS, Chronic Pelvic Pain
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: Hospital de Clinicas de Porto AlegreUniversity, hospital or other
Study start: Jun 2014
Primary completion: May 2015 (actual)
Study completion: May 2016 (actual)
First posted: 11 Jun 2014 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Active tDCS	Experimental	Device: transcranial direct current stimulation (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.
tDCS Sham	Sham comparator	Device: Sham Transcranial Direct Current StimulationThe 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.

Who may qualify

Ages: 18 to 55 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (1 listed)

age > 18 years old, non-menopausal, 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, who have the worst daily pain in the analogue visual scale > 4 cm on most of the days in the last month

Key exclusion criteria (1 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
transcranial direct current stimulation (tDCS)Also: tDCSThe 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	Active tDCS
Sham Transcranial Direct Current StimulationAlso: Sham tDCSThe 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	tDCS Sham

Primary outcome

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 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
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.
Change in Functional Pain Scale
Time frame: Once a week - Treatment Day 1, Day 8, Day 15, Day 22, Day 29
The Functional Pain Scale will be assessed by the Brazilian Profile of Chronic Pain: Screen (B-PCP:S) once a week, as follows: on 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
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).
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.

1 secondary outcome

Change in serum biomarkers level: The brain derived neurotrophic factor (BDNF) and interleukins
Time frame: up to Day 29

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2026.
Background: PubMed 21170277Valle A, Roizenblatt S, Botte S, Zaghi S, Riberto M, Tufik S, Boggio PS, Fregni F. Efficacy of anodal transcranial direct current stimulation (tDCS) for the treatment of fibromyalgia: results of a randomized, sham-controlled longitudinal clinical trial. J Pain Manag. 2009;2(3):353-361.
Background: PubMed 20945016Nacul 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.
Background: PubMed 18312584Boros 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.
Background: PubMed 14677403Nitsche MA, Liebetanz D, Antal A, Lang N, Tergau F, Paulus W. Modulation of cortical excitability by weak direct current stimulation--technical, safety and functional aspects. Suppl Clin Neurophysiol. 2003;56:255-76. doi: 10.1016/s1567-424x(09)70230-2. No abstract available.
Background: PubMed 20633386Nitsche MA, Cohen LG, Wassermann EM, Priori A, Lang N, Antal A, Paulus W, Hummel F, Boggio PS, Fregni F, Pascual-Leone A. Transcranial direct current stimulation: State of the art 2008. Brain Stimul. 2008 Jul;1(3):206-23. doi: 10.1016/j.brs.2008.06.004. Epub 2008 Jul 1.
Background: PubMed 20633407Fenton BW, Palmieri PA, Boggio P, Fanning J, Fregni F. A preliminary study of transcranial direct current stimulation for the treatment of refractory chronic pelvic pain. Brain Stimul. 2009 Apr;2(2):103-7. doi: 10.1016/j.brs.2008.09.009. Epub 2009 Feb 28.
Background: PubMed 23171145Caumo W, Ruehlman LS, Karoly P, Sehn F, Vidor LP, Dall-Agnol L, Chassot M, Torres IL. Cross-cultural adaptation and validation of the profile of chronic pain: screen for a Brazilian population. Pain Med. 2013 Jan;14(1):52-61. doi: 10.1111/j.1526-4637.2012.01528.x. Epub 2012 Nov 21.
Background: PubMed 23036076Sehn F, Chachamovich E, Vidor LP, Dall-Agnol L, de Souza IC, Torres IL, Fregni F, Caumo W. Cross-cultural adaptation and validation of the Brazilian Portuguese version of the pain catastrophizing scale. Pain Med. 2012 Nov;13(11):1425-35. doi: 10.1111/j.1526-4637.2012.01492.x. Epub 2012 Oct 4.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Wolnei Caumo, MD, PhD principal investigator

Hospital de Clinicas de Porto Alegre

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing transcranial direct current stimulation (tDCS) in people with Chronic Pain and Endometriosis, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02161302, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2026.