Transcranial Direct Current StimulationNCT05066568
Effect of Hypnosis Combined With Tdcs on Pain Perception and Cortical Excitability in Fibromyalgia
A study testing Active Tracranial Direct Current Stimulation, Hypnotic analgesia suggestion and Rest in people with Transcranial Direct Current Stimulation and Hypnosis, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
Trial summary
Fibromyalgia is a public health condition, which causes great functional disability. Conventional treatment modalities have been shown a very poor therapeutic response, in that most individuals end up becoming poly-medicated and refractory to treatment. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Transcranial Direct Current Stimulation, Hypnosis, Fibromyalgia
- What is being tested?
- Active Tracranial Direct Current Stimulation, Hypnotic analgesia suggestion and Rest
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteBrazil
- Study dates
- 2 Jul 2020to 30 Dec 2021
- 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 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women
- Literate
- Fibromyalgia diagnosis according to 2016 American College of Rheumatology criteria
- Pain score ≥ 6 in the Numerical Pain Scale during most of the time in the last 3 months.
- Score ≥ 8 /12 in the Waterloo-Stanford Group Hypnotic Susceptibility Scale C
Who cannot join
- Contraindication to Transcranial Magnetic Stimulation
- Metallic implant in brain
- Medical implants in brain
- Cardiac Pacemaker
- Cochlear implant
- History of drug or alcohol abuse in the last 6 months
Show all 12Show fewer
- Neurological disorders
- History of head trauma or neurosurgery
- Decompensated systemic diseases
- Chronic inflammatory diseases (lupus, rheumatoid arthritis, Sjogren syndrome, Reiter syndrome)
- Decompensated hypothyroidism
- History of cancer
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035-003
Wolnei Caumo, PhD, 55 51 33596377, wcaumo@hcpa.edu.br
Bruno Schein, Bachelor, 55 51 999664457, schein.bruno@gmail.com
About this study
Official title: Effect of Hypnosis Combined With Transcranial Direct Current Stimulation on Pain Perception and Cortical Excitability in Fibromyalgia: A Blinded Randomized Crossover Sham Controlled Clinical Trial
Fibromyalgia is a public health condition, which causes great functional disability. Conventional treatment modalities have been shown a very poor therapeutic response, in that most individuals end up becoming poly-medicated and refractory to treatment. Non-pharmacological techniques with promising effects on the syndrome symptoms include both hypnotic analgesia and the transcranial direct-current stimulation (tDCS). Giving the treatment limitations of this syndrome its important to better understand the pain processess in fibromyalgia and treatments effect. This project was developed in order to evaluate the synergistic effect of a hypnotic analgesia suggestion associated with tDCS over pain levels and cortical excitability in individuals with fibromyalgia over a nociceptive stimulation pattern.
Read the detailed description
Fibromyalgia is a public health condition, which causes great functional disability. Its consequences pervade the personal and social life of the patient, leading to significant impairments in their interpersonal relationships, including work, family and social spheres. The symptoms affect both the physical and emotional abilities. Conventional treatment modalities have been shown a very poor therapeutic response, in that most individuals end up becoming poly-medicated and refractory to treatment. Non-pharmacological techniques with promising effects on the syndrome symptoms include both hypnotic analgesia and the transcranial direct-current stimulation (tDCS). Giving the treatment limitations of this syndrome its important to better understand the pain processess in fibromyalgia and treatments effect. This project was developed in order to evaluate the synergistic effect of a hypnotic analgesia suggestion associated with tDCS over pain levels and cortical excitability in individuals with fibromyalgia over a nociceptive stimulation pattern. It will be performed as a blinded sham controlled cross-over randomized clinical trial. It will be included 20 female subjects diagnosed with fibromyalgia, according to the 2016 revision of the American College of Rheumatologycriteria (2010;2011), ranging in age from 18 to 65 years old, highly susceptible to the hypnosis technique (score ≥ 8) according to the Waterloo-Stanford Scale of Hypnotic Susceptibility (WSGC). They will be allocated in one of two groups, receiving with each cross-over one of the following interventions: A (active-tDCS), B (hypnotic analgesia suggestion), C (Rest), D (active-tDCS + hypnotic analgesia suggestion) and E (sham-tDCS + hypnotic analgesia suggestion). The primary endpoints will be the level of pain, measured by a numerical pain scale (NPS), during nociceptive stimuli induced by the cold pressor test and Short Intracortical Inhibition (SICI). The secondary endpoints will be descent pain modulation system power through the Conditioned Pain Modulation test (CPM - task); and the cortical excitability assessed by Motor Threshold (MT), Motor Evoked Potential (MEP), Cortical Silent Period (CSP) and Short Intracortical Facilitation (SICF) tests during Transcranial Magnetic Stimulation (TMS). The intra and inter-group comparisons will be made by means of two-way ANOVA followed by Bonferroni. A type I error of 5% and type II error of 20%. The present study hypothesizes a synergistic effect of both interventions on pain intensity reported on the Cold Pressor Test, as well as the reduction in the inhibition of cortical excitability level assessed by the TMS, compared to the same measures in an isolated manner.
- Being tested
- Active Tracranial Direct Current Stimulation, Hypnotic analgesia suggestion, Rest, Active tDCS + Hypnotic analgesia suggestion, Sham tDCS + Hypnotic analgesia suggestion
- Keywords
- chronic pain, fibromyalgia, hypnotic analgesia, tDCS, DPMS, Cold pressor test
- Medical subject headings
- Fibromyalgia, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active Tracranial Direct Current StimulationDevice
Also called a-tDCS
Site: dorsolateral prefrontal cortex. F3 anode and F4 catode. Electrode area: 35cm2 Current Intensity: 2mA Stimulation time: 20 min The current ramps up during 30 seconds reaching 2mA, staying this way until the last 30 seconds of stimulation, in wich the current slowly decreases to zero.
Hypnotic analgesia suggestionOther
Also called Hypnosis
The hypnotic induction protocol was standardized to be applied equally to all subjects. The protocol for hypnotic analgesia begins with an induction with a sequence of suggestions for the subjects to focus their attention on an individual stimulus, associated with progressive relaxation. After that, direct suggestions are given for comfort and pain reduction. The intervention lasts 20 minutes, with 12 minutes of induction and 8 minutes of hypnotic suggestions to reduce pain and leave the trance.
RestBehavioural
The patient is asked to remain seated still for 20 minutes.
Active tDCS + Hypnotic analgesia suggestionOther
Also called a-tDCS+HS
Site: dorsolateral prefrontal cortex. F3 anode and F4 catode. Electrode area: 35cm2 Current Intensity: 2mA Intervention time: 20 min The current ramps up during 30 seconds reaching 2mA, staying this way until the last 30 seconds of stimulation, in wich the current slowly decreases to zero.
The hypnotic induction protocol was standardized to be applied equally to all subjects. The protocol for hypnotic analgesia begins with an induction with a sequence of suggestions for the subjects to focus their attention on an individual stimulus, associated with progressive relaxation. After that, direct suggestions are given for comfort and pain reduction. The intervention lasts 20 minutes, with 12 minutes of induction and 8 minutes of hypnotic suggestions to reduce pain and leave the trance.
Sham tDCS + Hypnotic analgesia suggestionOther
Also called s-tDCS+HS
Site: dorsolateral prefrontal cortex. F3 anode and F4 catode. Electrode area: 35cm2 Current Intensity: 0mA Intervention time: 20 min The current is turned off after 30 seconds. The hypnotic induction protocol was standardized to be applied equally to all subjects. The protocol for hypnotic analgesia begins with an induction with a sequence of suggestions for the subjects to focus their attention on an individual stimulus, associated with progressive relaxation. After that, direct suggestions are given for comfort and pain reduction. The intervention lasts 20 minutes, with 12 minutes of induction and 8 minutes of hypnotic suggestions to reduce pain and leave the trance.
| Study group | Role | What they receive |
|---|---|---|
| Sequence of interventions starting with tDCS as the first intervention | Other | Week 1 Active tDCS left dorso-lateral prefrontal cortex. F3 anode F4 catode Area of electrodes: 35 cm2 Current intensity: 2mA Stimulation Time: 20min
Week 2 Rest The subjects will be asked to remain seated and still for 20 minutes.
Week 3 Hypnotic analgesia suggestion Classic approach. The intervention starts with a induction with suggestions for the subject to focus her attention in a single stimuli, combined with progressive relaxation. After that, direct suggestions are given for comfort and pain reduction.
Intervention time: 20 minutes
Week 4 Active tDCS + Hypnotic analgesia suggestion Intervention Time: 20 minutes.
Week 5 Sham tDCS + Hypnotic analgesia suggestion The sham tDCS will have the same areas of stimulation of the active tDCS, but the device will turn itself out after 30 seconds.
Intervention time: 20 minutes Receives: Device: Active Tracranial Direct Current Stimulation; Other: Hypnotic analgesia suggestion; Behavioral: Rest; Other: Active tDCS + Hypnotic analgesia suggestion; Other: Sham tDCS + Hypnotic analgesia suggestion |
| Sequence of interventions starting with Hypnosis as the first intervention | Other | Week 1 Hypnotic analgesia suggestion Classic approach. The intervention starts with a induction with suggestions for the subject to focus her attention in a single stimuli, combined with progressive relaxation. After that, direct suggestions are given for comfort and pain reduction.
Intervention time: 20 minutes
Week 2 Rest The subjects will be asked to remain seated and still for 20 minutes.
Week 3 Active tDCS left dorso-lateral prefrontal cortex. F3 anode F4 catode Area of electrodes: 35 cm2 Current intensity: 2mA Stimulation Time: 20min
Week 4 Sham tDCS + Hypnotic analgesia suggestion The sham tDCS will have the same areas of stimulation of the active tDCS, but the device will turn itself out after 30 seconds.
Intervention time: 20 minutes
Week 5 Active tDCS + Hypnotic analgesia suggestion Intervention Time: 20 minutes. Receives: Device: Active Tracranial Direct Current Stimulation; Other: Hypnotic analgesia suggestion; Behavioral: Rest; Other: Active tDCS + Hypnotic analgesia suggestion; Other: Sham tDCS + Hypnotic analgesia suggestion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Pain Levels during Cold Pressor Test from Pre to Post Interventions
Pain levels measured by a numerical visual analogue scale during Cold Pressor Test. The subject will have her hand submerged in cold water at 0 degrees celcius up to 2 minutes.
Measured: First assessed 40 minutes Pre interventions and 70 minutes post interventions
Changes in Pain Tolerance during Cold Pressor Test from Pre to Post Interventions
The time in the subject withstands with his hand submerged in cold water at 0 degrees celcius during Cold Pressor Test. With a maximum of 2 minutes.
Measured: First assessed 40 minutes Pre interventions and again 70 minutes post interventions
Changes in Short Cortical Inhibition during Transcranial Magnetic Stimulation from pre to post interventions
Short Cortical Inhibition measured by Transcranial Magnetic Stimulation. Using the MagOption for MagPro R30 and X100 device with electromyography.
Measured: First assessed 10 minutes Pre intervention and again 20 minutes post intervention
Secondary outcomes (5)
Changes in Numerical Pain Scale during Conditioned Pain Modulation-task from Pre to Post Interventions
Descending pain modulation system assessed by Conditioned Pain Modulation task. The subject will be asked to put her non-dominant hand in a bucket with cold water at 0 degrees celsius. The other forearm will receive a painful heat stimuli using a device. The CPM score is calculated using the difference between the mean pain of both arms during the outcome assessment.
Measured: First assessed 50 minutes pre interventions and again 1 hour post interventions
Changes in Motor Threshold from Pre to Post Interventions
Motor Threshold assessed by Transcranial Magnetic Stimulation
Measured: First assessed 30 minutes Pre interventions and again immediately post interventions
Changes in Motor Evoked Potential from Pre to Post Interventions
Motor Evoked Potential assessed by Transcranial Magnetic Stimulation
Measured: First assessed 25 minutes Pre interventions and again 5 minutes post interventions
Changes in Silent Period from Pre to Post Interventions
Silent Period assessed by Transcranial Magnetic Stimulation
Measured: First assessed 5 minutes Pre Interventions and again 25 minutes post interventions
Changes in Intra-cortical Facilitation from Pre to Post Interventions
Intra-cortical Facilitation assessed by Transcranial Magnetic Stimulation
Measured: First assessed 10 minutes Pre intervention and again 20 minutes post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2021
- Study start2 Jul 2020
- Primary completion30 Oct 2021 (estimated)
- Study completion30 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Transcranial Direct Current StimulationStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- Design: Randomized blinded factorial sham controlled clinical trial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wolnei Caumo, PhD, Principal investigator, Federal University of Rio Grande do Sul
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05066568
- Sponsor's protocol ID
- 2019-0688
- Status last verified
- Sep 2021
- First submitted
- 23 Aug 2021
- Last updated
- 4 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Schein B, Beltran G, Franca BR, Sanches PRS, Silva DP Jr, Torres IL, Fegni F, Caumo W. Effects of Hypnotic Analgesia and Transcranial Direct Current Stimulation on Pain Tolerance and Corticospinal Excitability in Individuals with Fibromyalgia: A Cross-Over Randomized Clinical Trial. J Pain Res. 2023 Jan 24;16:187-203. doi: 10.2147/JPR.S384373. eCollection 2023.
PubMed 36718400
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Hypnosis Combined With Transcranial Direct Current Stimulation on Pain Perception and Cortical Excitability in Fibromyalgia: A Blinded Randomized Crossover Sham Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT05066568
- Acronym / sponsor ID
- 2019-0688
- Keywords
- chronic pain, fibromyalgia, hypnotic analgesia, tDCS, DPMS, Cold pressor test
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Study start
- 2 Jul 2020 (actual)
- Primary completion
- 30 Oct 2021 (estimated)
- Study completion
- 30 Dec 2021 (estimated)
- First posted
- 4 Oct 2021 (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.
Fibromyalgia is a public health condition, which causes great functional disability. Conventional treatment modalities have been shown a very poor therapeutic response, in that most individuals end up becoming poly-medicated and refractory to treatment. Non-pharmacological techniques with promising effects on the syndrome symptoms include both hypnotic analgesia and the transcranial direct-current stimulation (tDCS). Giving the treatment limitations of this syndrome its important to better understand the pain processess in fibromyalgia and treatments effect. This project was developed in order to evaluate the synergistic effect of a hypnotic analgesia suggestion associated with tDCS over pain levels and cortical excitability in individuals with fibromyalgia over a nociceptive stimulation pattern.
Detailed description
Fibromyalgia is a public health condition, which causes great functional disability. Its consequences pervade the personal and social life of the patient, leading to significant impairments in their interpersonal relationships, including work, family and social spheres. The symptoms affect both the physical and emotional abilities. Conventional treatment modalities have been shown a very poor therapeutic response, in that most individuals end up becoming poly-medicated and refractory to treatment. Non-pharmacological techniques with promising effects on the syndrome symptoms include both hypnotic analgesia and the transcranial direct-current stimulation (tDCS). Giving the treatment limitations of this syndrome its important to better understand the pain processess in fibromyalgia and treatments effect. This project was developed in order to evaluate the synergistic effect of a hypnotic analgesia suggestion associated with tDCS over pain levels and cortical excitability in individuals with fibromyalgia over a nociceptive stimulation pattern. It will be performed as a blinded sham controlled cross-over randomized clinical trial. It will be included 20 female subjects diagnosed with fibromyalgia, according to the 2016 revision of the American College of Rheumatologycriteria (2010;2011), ranging in age from 18 to 65 years old, highly susceptible to the hypnosis technique (score ≥ 8) according to the Waterloo-Stanford Scale of Hypnotic Susceptibility (WSGC). They will be allocated in one of two groups, receiving with each cross-over one of the following interventions: A (active-tDCS), B (hypnotic analgesia suggestion), C (Rest), D (active-tDCS + hypnotic analgesia suggestion) and E (sham-tDCS + hypnotic analgesia suggestion). The primary endpoints will be the level of pain, measured by a numerical pain scale (NPS), during nociceptive stimuli induced by the cold pressor test and Short Intracortical Inhibition (SICI). The secondary endpoints will be descent pain modulation system power through the Conditioned Pain Modulation test (CPM - task); and the cortical excitability assessed by Motor Threshold (MT), Motor Evoked Potential (MEP), Cortical Silent Period (CSP) and Short Intracortical Facilitation (SICF) tests during Transcranial Magnetic Stimulation (TMS). The intra and inter-group comparisons will be made by means of two-way ANOVA followed by Bonferroni. A type I error of 5% and type II error of 20%. The present study hypothesizes a synergistic effect of both interventions on pain intensity reported on the Cold Pressor Test, as well as the reduction in the inhibition of cortical excitability level assessed by the TMS, compared to the same measures in an isolated manner.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Design: Randomized blinded factorial sham controlled clinical trial
| Arm | Type | Receives |
|---|---|---|
| Sequence of interventions starting with tDCS as the first intervention | Other | Device: Active Tracranial Direct Current Stimulation, Other: Hypnotic analgesia suggestion, Behavioral: Rest, Other: Active tDCS + Hypnotic analgesia suggestion, Other: Sham tDCS + Hypnotic analgesia suggestionWeek 1 Active tDCS left dorso-lateral prefrontal cortex. F3 anode F4 catode Area of electrodes: 35 cm2 Current intensity: 2mA Stimulation Time: 20min Week 2 Rest The subjects will be asked to remain seated and still for 20 minutes. Week 3 Hypnotic analgesia suggestion Classic approach. The intervention starts with a induction with suggestions for the subject to focus her attention in a single stimuli, combined with progressive relaxation. After that, direct suggestions are given for comfort and pain reduction. Intervention time: 20 minutes Week 4 Active tDCS + Hypnotic analgesia suggestion Intervention Time: 20 minutes. Week 5 Sham tDCS + Hypnotic analgesia suggestion The sham tDCS will have the same areas of stimulation of the active tDCS, but the device will turn itself out after 30 seconds. Intervention time: 20 minutes |
| Sequence of interventions starting with Hypnosis as the first intervention | Other | Device: Active Tracranial Direct Current Stimulation, Other: Hypnotic analgesia suggestion, Behavioral: Rest, Other: Active tDCS + Hypnotic analgesia suggestion, Other: Sham tDCS + Hypnotic analgesia suggestionWeek 1 Hypnotic analgesia suggestion Classic approach. The intervention starts with a induction with suggestions for the subject to focus her attention in a single stimuli, combined with progressive relaxation. After that, direct suggestions are given for comfort and pain reduction. Intervention time: 20 minutes Week 2 Rest The subjects will be asked to remain seated and still for 20 minutes. Week 3 Active tDCS left dorso-lateral prefrontal cortex. F3 anode F4 catode Area of electrodes: 35 cm2 Current intensity: 2mA Stimulation Time: 20min Week 4 Sham tDCS + Hypnotic analgesia suggestion The sham tDCS will have the same areas of stimulation of the active tDCS, but the device will turn itself out after 30 seconds. Intervention time: 20 minutes Week 5 Active tDCS + Hypnotic analgesia suggestion Intervention Time: 20 minutes. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Women
- Literate
- Fibromyalgia diagnosis according to 2016 American College of Rheumatology criteria
- Pain score ≥ 6 in the Numerical Pain Scale during most of the time in the last 3 months.
- Score ≥ 8 /12 in the Waterloo-Stanford Group Hypnotic Susceptibility Scale C
Key exclusion criteria (12 listed)
- Contraindication to Transcranial Magnetic Stimulation
- Metallic implant in brain
- Medical implants in brain
- Cardiac Pacemaker
- Cochlear implant
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 |
|---|---|---|
| Active Tracranial Direct Current StimulationAlso: a-tDCSSite: dorsolateral prefrontal cortex. F3 anode and F4 catode. Electrode area: 35cm2 Current Intensity: 2mA Stimulation time: 20 min The current ramps up during 30 seconds reaching 2mA, staying this way until the last 30 seconds of stimulation, in wich the current slowly decreases to zero. | Device | Sequence of interventions starting with Hypnosis as the first intervention, Sequence of interventions starting with tDCS as the first intervention |
| Hypnotic analgesia suggestionAlso: HypnosisThe hypnotic induction protocol was standardized to be applied equally to all subjects. The protocol for hypnotic analgesia begins with an induction with a sequence of suggestions for the subjects to focus their attention on an individual stimulus, associated with progressive relaxation. After that, direct suggestions are given for comfort and pain reduction. The intervention lasts 20 minutes, with 12 minutes of induction and 8 minutes of hypnotic suggestions to reduce pain and leave the trance. | Other | Sequence of interventions starting with Hypnosis as the first intervention, Sequence of interventions starting with tDCS as the first intervention |
| RestThe patient is asked to remain seated still for 20 minutes. | Behavioural | Sequence of interventions starting with Hypnosis as the first intervention, Sequence of interventions starting with tDCS as the first intervention |
| Active tDCS + Hypnotic analgesia suggestionAlso: a-tDCS+HSSite: dorsolateral prefrontal cortex. F3 anode and F4 catode. Electrode area: 35cm2 Current Intensity: 2mA Intervention time: 20 min The current ramps up during 30 seconds reaching 2mA, staying this way until the last 30 seconds of stimulation, in wich the current slowly decreases to zero. The hypnotic induction protocol was standardized to be applied equally to all subjects. The protocol for hypnotic analgesia begins with an induction with a sequence of suggestions for the subjects to focus their attention on an individual stimulus, associated with progressive relaxation. After that, direct suggestions are given for comfort and pain reduction. The intervention lasts 20 minutes, with 12 minutes of induction and 8 minutes of hypnotic suggestions to reduce pain and leave the trance. | Other | Sequence of interventions starting with Hypnosis as the first intervention, Sequence of interventions starting with tDCS as the first intervention |
| Sham tDCS + Hypnotic analgesia suggestionAlso: s-tDCS+HSSite: dorsolateral prefrontal cortex. F3 anode and F4 catode. Electrode area: 35cm2 Current Intensity: 0mA Intervention time: 20 min The current is turned off after 30 seconds. The hypnotic induction protocol was standardized to be applied equally to all subjects. The protocol for hypnotic analgesia begins with an induction with a sequence of suggestions for the subjects to focus their attention on an individual stimulus, associated with progressive relaxation. After that, direct suggestions are given for comfort and pain reduction. The intervention lasts 20 minutes, with 12 minutes of induction and 8 minutes of hypnotic suggestions to reduce pain and leave the trance. | Other | Sequence of interventions starting with Hypnosis as the first intervention, Sequence of interventions starting with tDCS as the first intervention |
Primary outcome
Changes in Pain Levels during Cold Pressor Test from Pre to Post Interventions
Time frame: First assessed 40 minutes Pre interventions and 70 minutes post interventions
Pain levels measured by a numerical visual analogue scale during Cold Pressor Test. The subject will have her hand submerged in cold water at 0 degrees celcius up to 2 minutes.
Changes in Pain Tolerance during Cold Pressor Test from Pre to Post Interventions
Time frame: First assessed 40 minutes Pre interventions and again 70 minutes post interventions
The time in the subject withstands with his hand submerged in cold water at 0 degrees celcius during Cold Pressor Test. With a maximum of 2 minutes.
Changes in Short Cortical Inhibition during Transcranial Magnetic Stimulation from pre to post interventions
Time frame: First assessed 10 minutes Pre intervention and again 20 minutes post intervention
Short Cortical Inhibition measured by Transcranial Magnetic Stimulation. Using the MagOption for MagPro R30 and X100 device with electromyography.
5 secondary outcomes
Changes in Numerical Pain Scale during Conditioned Pain Modulation-task from Pre to Post Interventions
Time frame: First assessed 50 minutes pre interventions and again 1 hour post interventions
Changes in Motor Threshold from Pre to Post Interventions
Time frame: First assessed 30 minutes Pre interventions and again immediately post interventions
Changes in Motor Evoked Potential from Pre to Post Interventions
Time frame: First assessed 25 minutes Pre interventions and again 5 minutes post interventions
Changes in Silent Period from Pre to Post Interventions
Time frame: First assessed 5 minutes Pre Interventions and again 25 minutes post interventions
Changes in Intra-cortical Facilitation from Pre to Post Interventions
Time frame: First assessed 10 minutes Pre intervention and again 20 minutes post intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2021.
- Derived from this study: PubMed 36718400Schein B, Beltran G, Franca BR, Sanches PRS, Silva DP Jr, Torres IL, Fegni F, Caumo W. Effects of Hypnotic Analgesia and Transcranial Direct Current Stimulation on Pain Tolerance and Corticospinal Excitability in Individuals with Fibromyalgia: A Cross-Over Randomized Clinical Trial. J Pain Res. 2023 Jan 24;16:187-203. doi: 10.2147/JPR.S384373. eCollection 2023.
- Individual participant dataSharing planned: Undecided
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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, PhD principal investigator
Federal University of Rio Grande do Sul
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active Tracranial Direct Current Stimulation, Hypnotic analgesia suggestion and Rest in people with Transcranial Direct Current Stimulation and Hypnosis, 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 5 inclusion and 12 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 4 Oct 2021. 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. 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?
Contact Wolnei Caumo, PHD (55 51 33596377, wcaumo@hcpa.edu.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Pain Levels during Cold Pressor Test from Pre to Post Interventions (time frame: First assessed 40 minutes Pre interventions and 70 minutes post interventions). The study lists 3 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 NCT05066568, which also lists 1 linked publication.
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 4 Oct 2021.