PainNCT04117256
Transcranial Versus Suboccipital Direct Current Stimulation
A study testing Direct Current Stimulation in people with Pain and Transcranial Direct Current Stimulation, run by University of Castilla-La Mancha at 1 site in Spain.
Trial summary
Randomized controlled trial, in parallel with cross-control design. Two groups of healthy subjects will be randomly selected to transcranial stimulation group or suboccipital stimulation group. Each group receive in a randomized order a real direct current session and a sham session. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain, Transcranial Direct Current Stimulation
- What is being tested?
- Direct Current Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- 10 Oct 2019to 30 Nov 2019
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age between 18 and 40 years.
- Healthy volunteers (without neurological injury and no history of pain in the last 6 months).
- Ability to perform all clinical test and understand the process of the study, as well as obtaining informed consent.
- Tolerance to the application of electrotherapy.
Who cannot join
- Previous history of surgical intervention at the cervical level.
- Have been treated with an electric current similar to that applied prior to the intervention.
- Sensitivity altered in the area of application of the intervention.
- No commitment to continuity.
- History of neuromuscular disease.
- Epilepsy.
Show all 18Show fewer
- Injuries, surgery or pain affecting the upper limb.
- Material of osteosynthesis at the cervical level.
- Diabetes.
- History of cancer.
- Cardiovascular disease.
- Presence of pacemakers or any other implanted electrical device.
- Take medication during the study and in the 7 days prior to the study.
- Consumption of narcotic substances during the study and in the 7 days prior to the study.
- Presence of tattoos or any other external agent introduced in the treatment and assessment area (hand).
- Pregnancy.
- Presence of severe and frequent headaches.
- Ulcers or scars in the skin at the location of the electrodes
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Transcranial and Suboccipital Direct Current Stimulation on Endogenous Pain Modulation System in Healthy Volunteers.
Randomized controlled trial, in parallel with cross-control design. Two groups of healthy subjects will be randomly selected to transcranial stimulation group or suboccipital stimulation group. Each group receive in a randomized order a real direct current session and a sham session. The study is based on the hypothesis that the application of direct current sitmulation applied at the suboccipital level produce higher modifications on endogenous pain modulation system than transcranial stimulation.
Read the detailed description
The development of the project will be based on the Declarations of the World Medical Association of Helsinki. Every subject will be informed about the nature of the study, willingness to participate, the proposed objectives, as well as possible adverse effects that may occur in its implementation. Every subject will be asked to give their signed consent to participate in the study. The study will be suspended at any time, if the patient wishes.
Healthy volunteers will be recruited from the city of Toledo, between the ages of 18 and 40. The detection and selection of the sample will be carried out between the students of the University of Castilla-La Mancha and personnel of the Hospital Nacional de Parapléjicos who meet the inclusion criteria and give their consent voluntarily to participate in the study.
The calculation of the sample size will be carried out using the G * Power software program (version 3.1), for clinical studies with two intervention groups. Conditioned pain modulation will be chosen as the primary outcome variable. Assuming an α level of 0.05 and a statistical power of 85%, with a moderate effect size for the ANOVA test (0.25).
The experiment will be carried out in the clinical laboratory of the Sensory-Motor Function Research Group of the Hospital Nacional de Parapléjicos. Under attenuated sound conditions, and at a stable temperature in the range of (22 °C-26 °C).
In the first session of the study, a small interview will be carried out to determine if there is any exclusion criterion. The initial measurements will consist of sociodemographic variables and psychological variables, which will then be used to categorize groups and analyze covariates. A parallel randomized controlled trial with cross-control design is proposed. Two groups of healthy subjects will be randomly selected to transcranial direct current stimulation (DCS) group or suboccipital DCS group. Each group receive in a randomized order and with a double blind design a real direct current session and a sham session. An assessment is made before and after each intervention.
Subjects will remain in a sitting position, with their backs resting in a relaxed position. In all interventions a direct current stimulator (DC-stimulator, Neuroconn) will be used.
- Conditions
- Pain, Transcranial Direct Current Stimulation
- Being tested
- Direct Current Stimulation, Sham DCS
- Keywords
- Direct Current Stimulation, Conditioned Pain Modulation, Endogenous Pain Modulation, Temporal Summation, Pressure Pain Threshold, Pain
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Direct Current StimulationDevice
20 minutes of direct current stimulation using an intensity of 1.5mA and electrode size of 6x4cm
Sham DCSDevice
20 minutes of sham stimulation. Subjects will be stimulated during the first 30 seconds. After that, a ramp down of 10 seconds and then the stimulator is turned-off.
| Study group | Role | What they receive |
|---|---|---|
| Transcranial Stimulation | Active comparator | Transcranial stimulation on the primary motor cortex (M1) with anode located on the point C3 (10/20 EEG system), and the cathode on contralateral supraorbital zone. Receives: Device: Direct Current Stimulation; Device: Sham DCS |
| Suboccipital Stimulation | Active comparator | Suboccipital stimulation with anode located at the upper cervical level and cathode was placed on the lateral part of right shoulder. Receives: Device: Direct Current Stimulation; Device: Sham DCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Conditioned Pain Modulation
For this protocol the test stimulus (TS) and the conditioning stimulus (CS) will be applied sequentially (first CS, followed by TS), heterotopic, and contralateral. The CS temperature will be 12 °C on the cold pressor test to induce a perception of pain. The subjects will have to submerge the non-dominant hand in the cold water bath for 30s, and evaluate the CS-induced pain intensity at 10, 20, and 30s (t1, t2 and t3 respectively). After assessing CS-induced pain intensity at the 30s of immersion participants will withdraw their hand from the water bath, and will have to fix their attention to the dominant hand where TS was immediately applied. The TS-induced pain assessment at 10, 20, and 30s (t1, t2 and t3).
Measured: Baseline at 0 min
Change from baseline Conditioned Pain Modulation
For this protocol the test stimulus (TS) and the conditioning stimulus (CS) will be applied sequentially (first CS, followed by TS), heterotopic, and contralateral. The CS temperature will be 12 °C on the cold pressor test to induce a perception of pain. The subjects will have to submerge the non-dominant hand in the cold water bath for 30s, and evaluate the CS-induced pain intensity at 10, 20, and 30s (t1, t2 and t3 respectively). After assessing CS-induced pain intensity at the 30s of immersion participants will withdraw their hand from the water bath, and will have to fix their attention to the dominant hand where TS was immediately applied. The TS-induced pain assessment at 10, 20, and 30s (t1, t2 and t3).
Measured: At 30 min
Secondary outcomes (4)
Baseline Temporal Summation
For the evaluation of the habituation and temporal summation of pain, heat stimuli of a "p-3" intensity without conditioning stimulus (CS) will be applied. The tonic heat stimulus will be applied on the surface of the tenar eminence of the dominant hand by 8 consecutive stimuli separated from each other by 1.5 seconds, evaluating the pain perceived during the first and the eighth stimulus, and at 15 seconds after the stimulation. The temperature will be determined individually, in order to reflect the general level of discomfort that the stimulus could produce according to the visual analog scale (0-10).
Measured: At 5 min
Change from baseline Temporal Summation
For the evaluation of the habituation and temporal summation of pain, heat stimuli of a "p-3" intensity without conditioning stimulus (CS) will be applied. The tonic heat stimulus will be applied on the surface of the tenar eminence of the dominant hand by 8 consecutive stimuli separated from each other by 1.5 seconds, evaluating the pain perceived during the first and the eighth stimulus, and at 15 seconds after the stimulation. The temperature will be determined individually, in order to reflect the general level of discomfort that the stimulus could produce according to the visual analog scale (0-10).
Measured: At 35 min
Baseline Pressure Pain Threshold
To record the mechanical pain threshold, a point will be marked on the Tibialis Anterior muscle and on the dorsal surface of the right hand, specifically on the second metacarpal lateral border, approximately 3 cm proximal to the interdigital fold. This zone is especially sensitive to pressure. For registration, the digital algometer with 0.1 N increment scale (Wagner Instruments brand, model FDIX), with a circular applicator of 1 cm in diameter will be used. Once the applicator is placed perpendicular to the skin, the pressure will increase at a rate of approximately 5 N / s. Three measures will be taken with an interval between measures of 10 seconds, the average of the three measurements will be taken as threshold of pain to the pressure.
Measured: at 10 min
Change from baseline Pressure Pain Threshold
To record the mechanical pain threshold, a point will be marked on the Tibialis Anterior muscle and on the dorsal surface of the right hand, specifically on the second metacarpal lateral border, approximately 3 cm proximal to the interdigital fold. This zone is especially sensitive to pressure. For registration, the digital algometer with 0.1 N increment scale (Wagner Instruments brand, model FDIX), with a circular applicator of 1 cm in diameter will be used. Once the applicator is placed perpendicular to the skin, the pressure will increase at a rate of approximately 5 N / s. Three measures will be taken with an interval between measures of 10 seconds, the average of the three measurements will be taken as threshold of pain to the pressure.
Measured: at 40 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2019
- Study start10 Oct 2019
- Primary completion4 Nov 2019
- Study completion30 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for PainStudies 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
- Model description
- Paralled randomized controlled trial with cross-control design. Two groups of subjects will be randomly selected, a Transcranial stimulation group and a suboccipital stimulation group. Each group will perform two intervention sessions in a randomized order, a session with direct current stimulation and a sham stimulation session.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Castilla-La Mancha
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad Rey Juan Carlos, Hospital Nacional de Parapléjicos de Toledo
- Responsible party
- Sponsor
- Investigators
- Julian Scott Taylor, Physiology, Study director, Hospital Nacional de Parapléjicos de Toledo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04117256
- Sponsor's protocol ID
- GuillermoGB
- Other IDs
- 0220493
- Status last verified
- Mar 2020
- First submitted
- 30 Sep 2019
- Last updated
- 16 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be shown if requested
Publications
Klein MM, Treister R, Raij T, Pascual-Leone A, Park L, Nurmikko T, Lenz F, Lefaucheur JP, Lang M, Hallett M, Fox M, Cudkowicz M, Costello A, Carr DB, Ayache SS, Oaklander AL. Transcranial magnetic stimulation of the brain: guidelines for pain treatment research. Pain. 2015 Sep;156(9):1601-1614. doi: 10.1097/j.pain.0000000000000210.
PubMed 25919472O'Connell NE, Wand BM, Marston L, Spencer S, Desouza LH. Non-invasive brain stimulation techniques for chronic pain. Cochrane Database Syst Rev. 2010 Sep 8;(9):CD008208. doi: 10.1002/14651858.CD008208.pub2.
PubMed 20824873Brunoni AR, Amadera J, Berbel B, Volz MS, Rizzerio BG, Fregni F. A systematic review on reporting and assessment of adverse effects associated with transcranial direct current stimulation. Int J Neuropsychopharmacol. 2011 Sep;14(8):1133-45. doi: 10.1017/S1461145710001690. Epub 2011 Feb 15.
PubMed 21320389Brunoni AR, Nitsche MA, Bolognini N, Bikson M, Wagner T, Merabet L, Edwards DJ, Valero-Cabre A, Rotenberg A, Pascual-Leone A, Ferrucci R, Priori A, Boggio PS, Fregni F. Clinical research with transcranial direct current stimulation (tDCS): challenges and future directions. Brain Stimul. 2012 Jul;5(3):175-195. doi: 10.1016/j.brs.2011.03.002. Epub 2011 Apr 1.
PubMed 22037126Albu S, Gomez-Soriano J, Avila-Martin G, Taylor J. Deficient conditioned pain modulation after spinal cord injury correlates with clinical spontaneous pain measures. Pain. 2015 Feb;156(2):260-272. doi: 10.1097/01.j.pain.0000460306.48701.f9.
PubMed 25599447Yarnitsky D. Role of endogenous pain modulation in chronic pain mechanisms and treatment. Pain. 2015 Apr;156 Suppl 1:S24-S31. doi: 10.1097/01.j.pain.0000460343.46847.58.
PubMed 25789433Staud R, Weyl EE, Riley JL 3rd, Fillingim RB. Slow temporal summation of pain for assessment of central pain sensitivity and clinical pain of fibromyalgia patients. PLoS One. 2014 Feb 18;9(2):e89086. doi: 10.1371/journal.pone.0089086. eCollection 2014.
PubMed 24558475Pud D, Granovsky Y, Yarnitsky D. The methodology of experimentally induced diffuse noxious inhibitory control (DNIC)-like effect in humans. Pain. 2009 Jul;144(1-2):16-9. doi: 10.1016/j.pain.2009.02.015. Epub 2009 Apr 8. No abstract available.
PubMed 19359095Nussbaum EL, Downes L. Reliability of clinical pressure-pain algometric measurements obtained on consecutive days. Phys Ther. 1998 Feb;78(2):160-9. doi: 10.1093/ptj/78.2.160.
PubMed 9474108Sanz J, García-Vera MP, Espinosa R, Fortún M, Vázquez C. Adaptación española del Inventario para la Depresión de Beck-II (BDI-II): 3. Propiedades psicométricas en pacientes con trastornos psicológicos. Clínica y Salud. 2005;16(2):121-42.
Spielberger CD. Manual for the State-Trait Anxiety Inventory (STAI Form Y). Consult Psychol Palo Alto. 1983;4-6.
Faul F, Erdfelder E, Lang AG, Buchner A. G*Power 3: a flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behav Res Methods. 2007 May;39(2):175-91. doi: 10.3758/bf03193146.
PubMed 17695343Fregni F, Boggio PS, Lima MC, Ferreira MJ, Wagner T, Rigonatti SP, Castro AW, Souza DR, Riberto M, Freedman SD, Nitsche MA, Pascual-Leone A. A sham-controlled, phase II trial of transcranial direct current stimulation for the treatment of central pain in traumatic spinal cord injury. Pain. 2006 May;122(1-2):197-209. doi: 10.1016/j.pain.2006.02.023. Epub 2006 Mar 27.
PubMed 16564618
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Transcranial and Suboccipital Direct Current Stimulation on Endogenous Pain Modulation System in Healthy Volunteers.
- ClinicalTrials.gov ID
- NCT04117256
- Acronym / sponsor ID
- GuillermoGB
- Conditions
- Pain, Transcranial Direct Current Stimulation
- Keywords
- Direct Current Stimulation, Conditioned Pain Modulation, Endogenous Pain Modulation, Temporal Summation, Pressure Pain Threshold, Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of Castilla-La ManchaUniversity, hospital or other
- Collaborators
- Universidad Rey Juan Carlos, Hospital Nacional de Parapléjicos de Toledo
- Study start
- 10 Oct 2019 (actual)
- Primary completion
- 4 Nov 2019 (actual)
- Study completion
- 30 Nov 2019 (actual)
- First posted
- 7 Oct 2019 (actual)
- 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.
Randomized controlled trial, in parallel with cross-control design. Two groups of healthy subjects will be randomly selected to transcranial stimulation group or suboccipital stimulation group. Each group receive in a randomized order a real direct current session and a sham session. The study is based on the hypothesis that the application of direct current sitmulation applied at the suboccipital level produce higher modifications on endogenous pain modulation system than transcranial stimulation.
Detailed description
The development of the project will be based on the Declarations of the World Medical Association of Helsinki. Every subject will be informed about the nature of the study, willingness to participate, the proposed objectives, as well as possible adverse effects that may occur in its implementation. Every subject will be asked to give their signed consent to participate in the study. The study will be suspended at any time, if the patient wishes.
Healthy volunteers will be recruited from the city of Toledo, between the ages of 18 and 40. The detection and selection of the sample will be carried out between the students of the University of Castilla-La Mancha and personnel of the Hospital Nacional de Parapléjicos who meet the inclusion criteria and give their consent voluntarily to participate in the study.
The calculation of the sample size will be carried out using the G * Power software program (version 3.1), for clinical studies with two intervention groups. Conditioned pain modulation will be chosen as the primary outcome variable. Assuming an α level of 0.05 and a statistical power of 85%, with a moderate effect size for the ANOVA test (0.25).
The experiment will be carried out in the clinical laboratory of the Sensory-Motor Function Research Group of the Hospital Nacional de Parapléjicos. Under attenuated sound conditions, and at a stable temperature in the range of (22 °C-26 °C).
In the first session of the study, a small interview will be carried out to determine if there is any exclusion criterion. The initial measurements will consist of sociodemographic variables and psychological variables, which will then be used to categorize groups and analyze covariates. A parallel randomized controlled trial with cross-control design is proposed. Two groups of healthy subjects will be randomly selected to transcranial direct current stimulation (DCS) group or suboccipital DCS group. Each group receive in a randomized order and with a double blind design a real direct current session and a sham session. An assessment is made before and after each intervention.
Subjects will remain in a sitting position, with their backs resting in a relaxed position. In all interventions a direct current stimulator (DC-stimulator, Neuroconn) will be used.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Paralled randomized controlled trial with cross-control design. Two groups of subjects will be randomly selected, a Transcranial stimulation group and a suboccipital stimulation group. Each group will perform two intervention sessions in a randomized order, a session with direct current stimulation and a sham stimulation session.
| Arm | Type | Receives |
|---|---|---|
| Transcranial Stimulation | Active comparator | Device: Direct Current Stimulation, Device: Sham DCSTranscranial stimulation on the primary motor cortex (M1) with anode located on the point C3 (10/20 EEG system), and the cathode on contralateral supraorbital zone. |
| Suboccipital Stimulation | Active comparator | Device: Direct Current Stimulation, Device: Sham DCSSuboccipital stimulation with anode located at the upper cervical level and cathode was placed on the lateral part of right shoulder. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age between 18 and 40 years.
- Healthy volunteers (without neurological injury and no history of pain in the last 6 months).
- Ability to perform all clinical test and understand the process of the study, as well as obtaining informed consent.
- Tolerance to the application of electrotherapy.
Key exclusion criteria (18 listed)
- Previous history of surgical intervention at the cervical level.
- Have been treated with an electric current similar to that applied prior to the intervention.
- Sensitivity altered in the area of application of the intervention.
- No commitment to continuity.
- History of neuromuscular disease.
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 |
|---|---|---|
| Direct Current Stimulation20 minutes of direct current stimulation using an intensity of 1.5mA and electrode size of 6x4cm | Device | Suboccipital Stimulation, Transcranial Stimulation |
| Sham DCS20 minutes of sham stimulation. Subjects will be stimulated during the first 30 seconds. After that, a ramp down of 10 seconds and then the stimulator is turned-off. | Device | Suboccipital Stimulation, Transcranial Stimulation |
Primary outcome
Conditioned Pain Modulation
Time frame: Baseline at 0 min
For this protocol the test stimulus (TS) and the conditioning stimulus (CS) will be applied sequentially (first CS, followed by TS), heterotopic, and contralateral. The CS temperature will be 12 °C on the cold pressor test to induce a perception of pain. The subjects will have to submerge the non-dominant hand in the cold water bath for 30s, and evaluate the CS-induced pain intensity at 10, 20, and 30s (t1, t2 and t3 respectively). After assessing CS-induced pain intensity at the 30s of immersion participants will withdraw their hand from the water bath, and will have to fix their attention to the dominant hand where TS was immediately applied. The TS-induced pain assessment at 10, 20, and 30s (t1, t2 and t3).
Change from baseline Conditioned Pain Modulation
Time frame: At 30 min
For this protocol the test stimulus (TS) and the conditioning stimulus (CS) will be applied sequentially (first CS, followed by TS), heterotopic, and contralateral. The CS temperature will be 12 °C on the cold pressor test to induce a perception of pain. The subjects will have to submerge the non-dominant hand in the cold water bath for 30s, and evaluate the CS-induced pain intensity at 10, 20, and 30s (t1, t2 and t3 respectively). After assessing CS-induced pain intensity at the 30s of immersion participants will withdraw their hand from the water bath, and will have to fix their attention to the dominant hand where TS was immediately applied. The TS-induced pain assessment at 10, 20, and 30s (t1, t2 and t3).
4 secondary outcomes
Baseline Temporal Summation
Time frame: At 5 min
Change from baseline Temporal Summation
Time frame: At 35 min
Baseline Pressure Pain Threshold
Time frame: at 10 min
Change from baseline Pressure Pain Threshold
Time frame: at 40 min
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 16 Mar 2020.
- Background: PubMed 25919472Klein MM, Treister R, Raij T, Pascual-Leone A, Park L, Nurmikko T, Lenz F, Lefaucheur JP, Lang M, Hallett M, Fox M, Cudkowicz M, Costello A, Carr DB, Ayache SS, Oaklander AL. Transcranial magnetic stimulation of the brain: guidelines for pain treatment research. Pain. 2015 Sep;156(9):1601-1614. doi: 10.1097/j.pain.0000000000000210.
- Background: PubMed 20824873O'Connell NE, Wand BM, Marston L, Spencer S, Desouza LH. Non-invasive brain stimulation techniques for chronic pain. Cochrane Database Syst Rev. 2010 Sep 8;(9):CD008208. doi: 10.1002/14651858.CD008208.pub2.
- Background: PubMed 21320389Brunoni AR, Amadera J, Berbel B, Volz MS, Rizzerio BG, Fregni F. A systematic review on reporting and assessment of adverse effects associated with transcranial direct current stimulation. Int J Neuropsychopharmacol. 2011 Sep;14(8):1133-45. doi: 10.1017/S1461145710001690. Epub 2011 Feb 15.
- Background: PubMed 22037126Brunoni AR, Nitsche MA, Bolognini N, Bikson M, Wagner T, Merabet L, Edwards DJ, Valero-Cabre A, Rotenberg A, Pascual-Leone A, Ferrucci R, Priori A, Boggio PS, Fregni F. Clinical research with transcranial direct current stimulation (tDCS): challenges and future directions. Brain Stimul. 2012 Jul;5(3):175-195. doi: 10.1016/j.brs.2011.03.002. Epub 2011 Apr 1.
- Background: PubMed 25599447Albu S, Gomez-Soriano J, Avila-Martin G, Taylor J. Deficient conditioned pain modulation after spinal cord injury correlates with clinical spontaneous pain measures. Pain. 2015 Feb;156(2):260-272. doi: 10.1097/01.j.pain.0000460306.48701.f9.
- Background: PubMed 25789433Yarnitsky D. Role of endogenous pain modulation in chronic pain mechanisms and treatment. Pain. 2015 Apr;156 Suppl 1:S24-S31. doi: 10.1097/01.j.pain.0000460343.46847.58.
- Background: PubMed 24558475Staud R, Weyl EE, Riley JL 3rd, Fillingim RB. Slow temporal summation of pain for assessment of central pain sensitivity and clinical pain of fibromyalgia patients. PLoS One. 2014 Feb 18;9(2):e89086. doi: 10.1371/journal.pone.0089086. eCollection 2014.
- Background: PubMed 19359095Pud D, Granovsky Y, Yarnitsky D. The methodology of experimentally induced diffuse noxious inhibitory control (DNIC)-like effect in humans. Pain. 2009 Jul;144(1-2):16-9. doi: 10.1016/j.pain.2009.02.015. Epub 2009 Apr 8. No abstract available.
- Background: PubMed 9474108Nussbaum EL, Downes L. Reliability of clinical pressure-pain algometric measurements obtained on consecutive days. Phys Ther. 1998 Feb;78(2):160-9. doi: 10.1093/ptj/78.2.160.
- BackgroundSanz J, García-Vera MP, Espinosa R, Fortún M, Vázquez C. Adaptación española del Inventario para la Depresión de Beck-II (BDI-II): 3. Propiedades psicométricas en pacientes con trastornos psicológicos. Clínica y Salud. 2005;16(2):121-42.
- BackgroundSpielberger CD. Manual for the State-Trait Anxiety Inventory (STAI Form Y). Consult Psychol Palo Alto. 1983;4-6.
- Background: PubMed 17695343Faul F, Erdfelder E, Lang AG, Buchner A. G*Power 3: a flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behav Res Methods. 2007 May;39(2):175-91. doi: 10.3758/bf03193146.
- Individual participant dataSharing planned: No. Data will be shown if requested
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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.
Julian Scott Taylor, Physiology study director
Hospital Nacional de Parapléjicos de Toledo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Direct Current Stimulation in people with Pain and Transcranial Direct Current Stimulation, run by University of Castilla-La Mancha at 1 site in Spain.
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 4 inclusion and 18 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 16 Mar 2020. 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 Spain. 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. 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?
Conditioned Pain Modulation (time frame: Baseline at 0 min). The study lists 2 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 NCT04117256, which also lists 13 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 16 Mar 2020.