Urinary Bladder, OveractiveNCT02456441
Effects of TENS in Autonomous System in Women With Overactive Bladder
A study testing Intervention group in people with Urinary Bladder, Overactive, run by Federal University of Health Science of Porto Alegre at 1 site in Brazil.
Trial summary
The International Continence Society (ICS) defines overactive bladder ( OAB) as a clinical syndrome characterized by urgency with or without urge incontinence , usually accompanied by frequency and nocturia , since in the absence of proven infection or other pathology related . Read more about this study
- Who is it for?
- Ages 40 to 60 years, women only
- Conditions the study is for
- Urinary Bladder, Overactive
- What is being tested?
- Intervention group
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteBrazil
- Study dates
- Mar 2014to Aug 2014
- 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 40 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Age between 40 and 60 years;
- Clinical Diagnosis of Overactive Bladder Syndrome non neurogenic type;
- Score Questionnaire OAB-V8, sum equal to or greater than eight (8);
- Calendar indicating voiding more than 8 micturitions in 24 hours;
- Complaints of urinary urgency.
Who cannot join
- With a diagnosis of lower urinary tract;
- Signs of leukorrhea / diagnosis of vaginitis;
- Pregnant women;
- Diagnosed with bladder cancer and other pelvic organs;
- With a history of pelvic radiotherapy;
- With change in the sensitivity of the pelvis and lower limbs region;
Show all 10Show fewer
- With Diabetes Mellitus;
- With known neurologic diseases;
- Patients on medications that may affect the autonomic nervous system, including anticholinergics, alpha-adrenergic antagonists, tricyclic antidepressants, serotonin, antimuscarinic, beta-receptor agonists or antagonists and antihypertensive agents;
- Use of cardiac pacemakers.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Caroline Helena Lazzarotto de Lima
Frederico Westphalen, Rio Grande do Sul, 98400000
About this study
Official title: The Effects of Transcutaneous Tibial Nerve Stimulation in Sympathetic and Parasympathetic System in Women With Overactive Bladder: Randomized Clinical Trial
The International Continence Society (ICS) defines overactive bladder ( OAB) as a clinical syndrome characterized by urgency with or without urge incontinence , usually accompanied by frequency and nocturia , since in the absence of proven infection or other pathology related . The negative impact on quality of life of patients with OAB is already known. The etiology and pathophysiology of OAB are not completely understood. However, studies indicate an alteration of sympathetic and parasympathetic nerve stimulation involved in the mechanism of OAB. A Transcutaneous Electrical stimulation of the Tibial Nerve ( TENS) has been studied as a noninvasive and inexpensive , treating the symptoms of this syndrome therapeutic way . However, no studies in the literature evaluating the effect of electroconvulsive therapy on the mechanisms involved in sympathetic and parasympathetic modulation in these women . The objective of this study is to investigate the effects of TENS on the sympathetic and parasympathetic system in women with OAB . This is a randomized, double -blind , which will be assessed , first, in a pilot study , 30 female patients with OAB randomly allocated into 2 groups : TENS group and placebo group. Interventions take place in one day assessment of the sympathetic and parasympathetic nervous system are performed . After collecting the data will be analyzed in accordance with the statistical analysis.
Read the detailed description
Hypothesis True:Electrical stimulation of the tibial nerve (TENS) decreases the activity of the parasympathetic nervous system and increases the activity of the sympathetic nervous system in women with overactive bladder.
Null Hypothesis: The electrical stimulation of the tibial nerve (TENS) does not decrease the activity of the parasympathetic nervous system and does not increase the activity of the sympathetic nervous system in women with overactive bladder.
Alternative Hypothesis: The electrical stimulation of the tibial nerve (TENS) increases the activity of the parasympathetic nervous system and decreases the activity of the sympathetic nervous system in women with overactive bladder.
Intervention Programmes
The randomization technique is carried out through sequential numbers kept in opaque envelopes, not translucent and closed. This takes into account that a major goal of randomization is to prevent the researcher to identify which intervention will be performed in each patient. The generation of sequence numbers will be made by researcher "blind" the study after patient selection criteria for inclusion and exclusion. The sequence of numbers to be used for randomization will be kept confidential until the exact moment of the beginning of the intervention.
In this study, two self-adhesive electrodes, one immediately behind the medial malleolus and the other 10 cm above will be used. Through a chain of 1Hz, the aim is to correctly identify the tibial nerve. This position is confirmed with the rhythmic movement of the finger flexion. The frequency is then changed to 10Hz, the pulse width set at 200 "microseconds" and adjusted according to the intensity threshold for each patient, below motor threshold. This current generator also has a device, the VIF (variation in intensity and frequency) that aims to ease the accommodation of sensory receptors and enhance its effects. The application time is 30 minutes.
The placebo group will receive active current for 30 seconds and then will gradually decrease by 15 seconds to not pass any current.
It is noteworthy that all study participants will be instructed not to eat, not drink, not smoke and do not exercise two hours prior to data collection.
Evaluation of the sympathetic and parasympathetic system For the analysis of Heart Rate Variability (HRV) time series of RR intervals obtained from continuous ECG signal recorded (sampling frequency = 1 kHz) for the MP150 system (Biopac, California, USA) will be interpolated and decimated to obtain equally spaced in time series and then subjected to a Fast Fourier Transform (FFT) algorithm developed using a Matlab (Matlab 6.0, Mathworks Inc., USA) language. The spectral power is calculated by integrating each frequency band of interest. The time series of RR will be analyzed in the time domain and the frequency and variability parameters and autonomic balance will be obtained. In the time domain we calculate the mean values of RR intervals, standard deviation and the square root of the sum of the square of successive differences (rMSSD). The evaluation of the sympathetic and parasympathetic nervous system will be held at the Federal University of Health Sciences of Porto Alegre (UFCSPA), the Laboratory of Physiology before, during and after application of TENS.
Calculation Sample
Due to lack of studies relating to study the effects of the sympathetic and parasympathetic TENS in women with overactive bladder nervous system, a pilot study will be conducted which will consist of:
Group A: TENS Group, composed of 15 women with overactive bladder and Group B: placebo group, consisting of 15 women with overactive bladder.
Based on the obtained values the actual sample size calculation for the study will be conducted.
- Conditions
- Urinary Bladder, Overactive
- Being tested
- Intervention group, Placebo group
- Medical subject headings
- Urinary Bladder, Overactive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention groupOther
Also called Transcutaneous electric stimulation
The device current generator TENS used was " Neurodyn Portable Tens / Fes " of IBRAMED brand. Two self-adhesive electrodes, one immediately behind the medial malleolus and the other 10 cm above will be used. Through a chain of 1Hz, the aim is to correctly identify the tibial nerve. This position is confirmed with the rhythmic movement of the finger flexion. The frequency is then changed to 10Hz, the pulse width set at 200 "microseconds" and adjusted according to the intensity threshold for each patient, below motor threshold. This current generator also has a device, the VIF (variation in intensity and frequency) that aims to ease the accommodation of sensory receptors and enhance its effects. The application time is 30 minutes
Placebo groupOther
Also called GP
The placebo group received an active current for 15 seconds by means of an apparatus also IBRAMED brand externally similar to that used in GI. Two self-adhesive electrodes, one immediately behind the medial malleolus and the other 10 cm above will be used.The application time for GP also was 30 minutes .
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Will be obtained the evolution parasympathetic and sympathetic system 10 minutes after TENS application, through Heart Hate Variability analysis. Receives: Other: Intervention group |
| Placebo group | Placebo comparator | Will be obtained the evolution parasympathetic and sympathetic system 10 minutes after placebo current application, through Heart Hate Variability analysis. p. The placebo group will receive transcutaneous electric stimulation, for 30 seconds and then will gradually decrease by 15 seconds to not pass any current. This approach will aim to masking of the subject. Receives: Other: Placebo group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parasympathetic and sympathetic system values obtained from heart rate variability (HRV) after TENS application
For the analysis of HRV time, series of RR intervals obtained from continuous ECG signal recorded (sampling frequency = 1 kHz) for the MP150 system (Biopac, California, USA) will be interpolated and decimated to obtain equally spaced in time series and then subjected to a Fast Fourier Transform (FFT) algorithm developed using a Matlab (Matlab 6.0, Mathworks Inc., USA) language. The spectral power is calculated by integrating each frequency band of interest. The time series of RR will be analyzed in the time domain and the frequency and variability parameters and autonomic balance will be obtained. In the time domain we calculate the mean values of RR intervals, standard deviation and the square root of the sum of the square of successive differences (rMSSD).
Measured: 50 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2015 (estimated)
- Study startMar 2014
- Primary completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Urinary Bladder, OveractiveStudies of the same condition, open and under way.
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of Health Science of Porto Alegre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luís Henrique Telles da Rosa, Federal University of Health Science of Porto Alegre
- Investigators
- Luís T da Rosa, PhD, Principal investigator, Federal University of Health Science of Porto AlegreCaroline HL de Lima, Msc, Study chair, Federal University of Health Science of Porto AlegrePatrícia V da Rosa, PhD, Study director, Federal University of Health Science of Porto AlegreRodrigo DM Plentz, PhD, Study director, Federal University of Health Science of Porto AlegreCinara Stein, PhD, Study chair, Federal University of Health Science of Porto AlegreFabrício E Macagnan, PhD, Study chair, Federal University of Health Science of Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02456441
- Sponsor's protocol ID
- CAAE 17136213.0.0000.5345
- Status last verified
- May 2015
- First submitted
- 6 Apr 2015
- Last updated
- 28 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Rosier PF, Hosker GL, Szabo L, Capewell A, Gajewski JB, Sand PK; International Consultation on Incontinence 2008 Committee on Dynamic Testing. Executive Summary: The International Consultation on Incontinence 2008--Committee on: "Dynamic Testing"; for urinary or fecal incontinence. Part 3: Anorectal physiology studies. Neurourol Urodyn. 2010;29(1):153-8. doi: 10.1002/nau.20762.
PubMed 19693957de Groat WC. Integrative control of the lower urinary tract: preclinical perspective. Br J Pharmacol. 2006 Feb;147 Suppl 2(Suppl 2):S25-40. doi: 10.1038/sj.bjp.0706604.
PubMed 16465182Ben-Dror I, Weissman A, Leurer MK, Eldor-Itskovitz J, Lowenstein L. Alterations of heart rate variability in women with overactive bladder syndrome. Int Urogynecol J. 2012 Aug;23(8):1081-6. doi: 10.1007/s00192-012-1738-7. Epub 2012 Apr 11.
PubMed 22491716Coyne KS, Zyczynski T, Margolis MK, Elinoff V, Roberts RG. Validation of an overactive bladder awareness tool for use in primary care settings. Adv Ther. 2005 Jul-Aug;22(4):381-94. doi: 10.1007/BF02850085.
PubMed 16418145Banakhar MA, Al-Shaiji TF, Hassouna MM. Pathophysiology of overactive bladder. Int Urogynecol J. 2012 Aug;23(8):975-82. doi: 10.1007/s00192-012-1682-6. Epub 2012 Feb 7.
PubMed 22310925Haylen BT, de Ridder D, Freeman RM, Swift SE, Berghmans B, Lee J, Monga A, Petri E, Rizk DE, Sand PK, Schaer GN; International Urogynecological Association; International Continence Society. An International Urogynecological Association (IUGA)/International Continence Society (ICS) joint report on the terminology for female pelvic floor dysfunction. Neurourol Urodyn. 2010;29(1):4-20. doi: 10.1002/nau.20798.
PubMed 19941278Fall M, Lindstrom S. Electrical stimulation. A physiologic approach to the treatment of urinary incontinence. Urol Clin North Am. 1991 May;18(2):393-407.
PubMed 2017820
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Transcutaneous Tibial Nerve Stimulation in Sympathetic and Parasympathetic System in Women With Overactive Bladder: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02456441
- Acronym / sponsor ID
- CAAE 17136213.0.0000.5345
- Conditions
- Urinary Bladder, Overactive
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Federal University of Health Science of Porto AlegreUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Aug 2014 (actual)
- First posted
- 28 May 2015 (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 International Continence Society (ICS) defines overactive bladder ( OAB) as a clinical syndrome characterized by urgency with or without urge incontinence , usually accompanied by frequency and nocturia , since in the absence of proven infection or other pathology related . The negative impact on quality of life of patients with OAB is already known. The etiology and pathophysiology of OAB are not completely understood. However, studies indicate an alteration of sympathetic and parasympathetic nerve stimulation involved in the mechanism of OAB. A Transcutaneous Electrical stimulation of the Tibial Nerve ( TENS) has been studied as a noninvasive and inexpensive , treating the symptoms of this syndrome therapeutic way . However, no studies in the literature evaluating the effect of electroconvulsive therapy on the mechanisms involved in sympathetic and parasympathetic modulation in these women . The objective of this study is to investigate the effects of TENS on the sympathetic and parasympathetic system in women with OAB . This is a randomized, double -blind , which will be assessed , first, in a pilot study , 30 female patients with OAB randomly allocated into 2 groups : TENS group and placebo group. Interventions take place in one day assessment of the sympathetic and parasympathetic nervous system are performed . After collecting the data will be analyzed in accordance with the statistical analysis.
Detailed description
Hypothesis True:Electrical stimulation of the tibial nerve (TENS) decreases the activity of the parasympathetic nervous system and increases the activity of the sympathetic nervous system in women with overactive bladder.
Null Hypothesis: The electrical stimulation of the tibial nerve (TENS) does not decrease the activity of the parasympathetic nervous system and does not increase the activity of the sympathetic nervous system in women with overactive bladder.
Alternative Hypothesis: The electrical stimulation of the tibial nerve (TENS) increases the activity of the parasympathetic nervous system and decreases the activity of the sympathetic nervous system in women with overactive bladder.
Intervention Programmes
The randomization technique is carried out through sequential numbers kept in opaque envelopes, not translucent and closed. This takes into account that a major goal of randomization is to prevent the researcher to identify which intervention will be performed in each patient. The generation of sequence numbers will be made by researcher "blind" the study after patient selection criteria for inclusion and exclusion. The sequence of numbers to be used for randomization will be kept confidential until the exact moment of the beginning of the intervention.
In this study, two self-adhesive electrodes, one immediately behind the medial malleolus and the other 10 cm above will be used. Through a chain of 1Hz, the aim is to correctly identify the tibial nerve. This position is confirmed with the rhythmic movement of the finger flexion. The frequency is then changed to 10Hz, the pulse width set at 200 "microseconds" and adjusted according to the intensity threshold for each patient, below motor threshold. This current generator also has a device, the VIF (variation in intensity and frequency) that aims to ease the accommodation of sensory receptors and enhance its effects. The application time is 30 minutes.
The placebo group will receive active current for 30 seconds and then will gradually decrease by 15 seconds to not pass any current.
It is noteworthy that all study participants will be instructed not to eat, not drink, not smoke and do not exercise two hours prior to data collection.
Evaluation of the sympathetic and parasympathetic system For the analysis of Heart Rate Variability (HRV) time series of RR intervals obtained from continuous ECG signal recorded (sampling frequency = 1 kHz) for the MP150 system (Biopac, California, USA) will be interpolated and decimated to obtain equally spaced in time series and then subjected to a Fast Fourier Transform (FFT) algorithm developed using a Matlab (Matlab 6.0, Mathworks Inc., USA) language. The spectral power is calculated by integrating each frequency band of interest. The time series of RR will be analyzed in the time domain and the frequency and variability parameters and autonomic balance will be obtained. In the time domain we calculate the mean values of RR intervals, standard deviation and the square root of the sum of the square of successive differences (rMSSD). The evaluation of the sympathetic and parasympathetic nervous system will be held at the Federal University of Health Sciences of Porto Alegre (UFCSPA), the Laboratory of Physiology before, during and after application of TENS.
Calculation Sample
Due to lack of studies relating to study the effects of the sympathetic and parasympathetic TENS in women with overactive bladder nervous system, a pilot study will be conducted which will consist of:
Group A: TENS Group, composed of 15 women with overactive bladder and Group B: placebo group, consisting of 15 women with overactive bladder.
Based on the obtained values the actual sample size calculation for the study will be conducted.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Intervention groupWill be obtained the evolution parasympathetic and sympathetic system 10 minutes after TENS application, through Heart Hate Variability analysis. |
| Placebo group | Placebo comparator | Other: Placebo groupWill be obtained the evolution parasympathetic and sympathetic system 10 minutes after placebo current application, through Heart Hate Variability analysis. p. The placebo group will receive transcutaneous electric stimulation, for 30 seconds and then will gradually decrease by 15 seconds to not pass any current. This approach will aim to masking of the subject. |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age between 40 and 60 years;
- Clinical Diagnosis of Overactive Bladder Syndrome non neurogenic type;
- Score Questionnaire OAB-V8, sum equal to or greater than eight (8);
- Calendar indicating voiding more than 8 micturitions in 24 hours;
- Complaints of urinary urgency.
Key exclusion criteria (10 listed)
- With a diagnosis of lower urinary tract;
- Signs of leukorrhea / diagnosis of vaginitis;
- Pregnant women;
- Diagnosed with bladder cancer and other pelvic organs;
- With a history of pelvic radiotherapy;
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 |
|---|---|---|
| Intervention groupAlso: Transcutaneous electric stimulationThe device current generator TENS used was " Neurodyn Portable Tens / Fes " of IBRAMED brand. Two self-adhesive electrodes, one immediately behind the medial malleolus and the other 10 cm above will be used. Through a chain of 1Hz, the aim is to correctly identify the tibial nerve. This position is confirmed with the rhythmic movement of the finger flexion. The frequency is then changed to 10Hz, the pulse width set at 200 "microseconds" and adjusted according to the intensity threshold for each patient, below motor threshold. This current generator also has a device, the VIF (variation in intensity and frequency) that aims to ease the accommodation of sensory receptors and enhance its effects. The application time is 30 minutes | Other | Intervention group |
| Placebo groupAlso: GPThe placebo group received an active current for 15 seconds by means of an apparatus also IBRAMED brand externally similar to that used in GI. Two self-adhesive electrodes, one immediately behind the medial malleolus and the other 10 cm above will be used.The application time for GP also was 30 minutes . | Other | Placebo group |
Primary outcome
Parasympathetic and sympathetic system values obtained from heart rate variability (HRV) after TENS application
Time frame: 50 minutes
For the analysis of HRV time, series of RR intervals obtained from continuous ECG signal recorded (sampling frequency = 1 kHz) for the MP150 system (Biopac, California, USA) will be interpolated and decimated to obtain equally spaced in time series and then subjected to a Fast Fourier Transform (FFT) algorithm developed using a Matlab (Matlab 6.0, Mathworks Inc., USA) language. The spectral power is calculated by integrating each frequency band of interest. The time series of RR will be analyzed in the time domain and the frequency and variability parameters and autonomic balance will be obtained. In the time domain we calculate the mean values of RR intervals, standard deviation and the square root of the sum of the square of successive differences (rMSSD).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2015.
- Background: PubMed 19693957Rosier PF, Hosker GL, Szabo L, Capewell A, Gajewski JB, Sand PK; International Consultation on Incontinence 2008 Committee on Dynamic Testing. Executive Summary: The International Consultation on Incontinence 2008--Committee on: "Dynamic Testing"; for urinary or fecal incontinence. Part 3: Anorectal physiology studies. Neurourol Urodyn. 2010;29(1):153-8. doi: 10.1002/nau.20762.
- Background: PubMed 16465182de Groat WC. Integrative control of the lower urinary tract: preclinical perspective. Br J Pharmacol. 2006 Feb;147 Suppl 2(Suppl 2):S25-40. doi: 10.1038/sj.bjp.0706604.
- Background: PubMed 22491716Ben-Dror I, Weissman A, Leurer MK, Eldor-Itskovitz J, Lowenstein L. Alterations of heart rate variability in women with overactive bladder syndrome. Int Urogynecol J. 2012 Aug;23(8):1081-6. doi: 10.1007/s00192-012-1738-7. Epub 2012 Apr 11.
- Background: PubMed 16418145Coyne KS, Zyczynski T, Margolis MK, Elinoff V, Roberts RG. Validation of an overactive bladder awareness tool for use in primary care settings. Adv Ther. 2005 Jul-Aug;22(4):381-94. doi: 10.1007/BF02850085.
- Background: PubMed 22310925Banakhar MA, Al-Shaiji TF, Hassouna MM. Pathophysiology of overactive bladder. Int Urogynecol J. 2012 Aug;23(8):975-82. doi: 10.1007/s00192-012-1682-6. Epub 2012 Feb 7.
- Background: PubMed 19941278Haylen BT, de Ridder D, Freeman RM, Swift SE, Berghmans B, Lee J, Monga A, Petri E, Rizk DE, Sand PK, Schaer GN; International Urogynecological Association; International Continence Society. An International Urogynecological Association (IUGA)/International Continence Society (ICS) joint report on the terminology for female pelvic floor dysfunction. Neurourol Urodyn. 2010;29(1):4-20. doi: 10.1002/nau.20798.
- Background: PubMed 2017820Fall M, Lindstrom S. Electrical stimulation. A physiologic approach to the treatment of urinary incontinence. Urol Clin North Am. 1991 May;18(2):393-407.
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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.
Luís T da Rosa, PhD principal investigator
Federal University of Health Science of Porto Alegre
Caroline HL de Lima, Msc study chair
Federal University of Health Science of Porto Alegre
Patrícia V da Rosa, PhD study director
Federal University of Health Science of 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 Intervention group in people with Urinary Bladder, Overactive, run by Federal University of Health Science of 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 5 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 28 May 2015. 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?
Results are not available in the source record.
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?
Parasympathetic and sympathetic system values obtained from heart rate variability (HRV) after TENS application (time frame: 50 minutes). 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 NCT02456441, which also lists 7 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 28 May 2015.