Effect of Hypnosis Combined to Transcranial Direct Stimulation in Pain

NCT ID: NCT03744897

Last Updated: 2018-11-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-07-18
• Study Completion Date: 2018-11-01

Brief Summary

Pain is a public health condition, which causes great functional disability. Its consequences pervade the personal and social life of the patient, leading to significant changes in their interpersonal relationships, including work, family and social spheres, reducing the ability to perform daily activities. Conventional treatment modalities have been show a very poor therapeutic response, in that most individuals end up becoming polymedicated patients and refractory to treatment. Among non-pharmacological techniques with promising analgesic effects it includes both the hypnotic analgesia and the transcranial stimulation of direct current (tDCS).

Detailed Description

Introduction: Pain is a public health condition, which causes great functional disability. Its consequences pervade the personal and social life of the patient, leading to significant changes in their interpersonal relationships, including work, family and social spheres, reducing the ability to perform daily activities. Conventional treatment modalities have been show a very poor therapeutic response, in that most individuals end up becoming polymedicated patients and refractory to treatment. Among non-pharmacological techniques with promising analgesic effects it includes both the hypnotic analgesia and the transcranial stimulation of direct current (tDCS). Objective: To evaluate the synergistic effect of hypnotic analgesia associated with tDCS under metabolites parameters and pain levels in healthy individuals before a nociceptive stimulation pattern. Methods: it will be performed a blinded crossover sham controlled randomized clinical trial. It will be included 32 woman healthy subjects, Susceptible to the hypnosis technique according to the Scale of Hypnotic Susceptibility (WSGC) Scale of Hypnotic Scale score. aged 18 to 65. They will be allocated in one of the following groups: active tDCS + hypnotic analgesia, sham tDCS + hypnotic analgesia, hypnotic analgesia and tDCS . After a 7 days interval, the groups will be crossed in order to receive the opposite intervention of the first week. The primary endpoints will be the electrophysiological brain parameters, such as changes in the Theta, Alpha and Gamma waves, as measured by EEG. The secondary endpoints will be the level of pain, measured against nociceptive induced by the cold test and stimuli standardized pressure through algometry pressure and power down system modulatory pain, pain using the subject test - CPM - task. The intra and inter-group comparisons will be made by means of two-way ANOVA followed by Bonferroni. A p significance level of <0.05 was established. Expected results: This study hypothesizes that a synergistic effect of analgesic techniques in pain levels in healthy subjects compared to isolated character.

Conditions

Pain Perception; Pain Acute

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

Hypnotic analgesia

Intervention:

• Subjects will receive hypnotic analgesia

Group Type: EXPERIMENTAL

Hypnotic analgesia

Intervention Type: BEHAVIORAL

Subjects will receive hypnotic analgesia during 20 minutes

a-tDCS

Intervention: transcranial direct current stimulation - tDCS

• active tDCS stimulation
• montage: bilateral DLPFC anodal/left and cathodal/right
• current:2 milliamps
• time: 20 minutes

Group Type: EXPERIMENTAL

Hypnotic analgesia

Intervention Type: BEHAVIORAL

Subjects will receive hypnotic analgesia during 20 minutes

s-tDCS

Intervention Type: DEVICE

Subjects will receive sham transcranial direct stimulation over bilateral DLPFC left/anode right/cathodal, 0mA, 20 minutes

s-tDCS

Sham comparator: transcranial direct current stimulation - tDCS

• sham tDCS stimulation
• montage: bilateral DLPFC anodal/left and cathodal/right
• current: 0 milliamps
• time: 20 minutes

Group Type: SHAM_COMPARATOR

a-tDCS

Intervention Type: DEVICE

Subjects will receive transcranial direct stimulation over bilateral DLPFC left/anode right/cathodal, 2mA, 20 minutes

Hypnotic analgesia + a-tDCS

Intervention Type: OTHER

Subjects will receive hypnotic analgesia associated to transcranial direct stimulation over bilateral DLPFC left/anode right/cathodal, 2mA, 20 minutes

Hypnotic analgesia + a-tDCS

Intervention:

• hypnotic analgesia
• active tDCS stimulation
• montage: bilateral DLPFC anodal/left and cathodal/right
• current:2 milliamps
• time: 20 minutes

Group Type: EXPERIMENTAL

Hypnotic analgesia + a-tDCS

Intervention Type: OTHER

Subjects will receive hypnotic analgesia associated to transcranial direct stimulation over bilateral DLPFC left/anode right/cathodal, 2mA, 20 minutes

Interventions

Hypnotic analgesia

Subjects will receive hypnotic analgesia during 20 minutes

Intervention Type: BEHAVIORAL

a-tDCS

Subjects will receive transcranial direct stimulation over bilateral DLPFC left/anode right/cathodal, 2mA, 20 minutes

Intervention Type: DEVICE

Hypnotic analgesia + a-tDCS

Subjects will receive hypnotic analgesia associated to transcranial direct stimulation over bilateral DLPFC left/anode right/cathodal, 2mA, 20 minutes

Intervention Type: OTHER

s-tDCS

Subjects will receive sham transcranial direct stimulation over bilateral DLPFC left/anode right/cathodal, 0mA, 20 minutes

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Healthy
• Female
• 11 years of schooling
• 12 cut-off at Waterloo-Stanford Group C (WSGC)

Exclusion Criteria

• hearing loss subjects
• formal contraindication to tDCS (pregnancy, deep brain device, epilepsy, seizure)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Hospital de Clinicas de Porto Alegre

OTHER

Sponsor Role: lead

Responsible Party

Wolnei Caumo

Professor of Surgery Department - School of Medicine - Head of HCPA Pain and Palliative Care Outpatient

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Wolnei Caumo, MD. PhD

Role: PRINCIPAL_INVESTIGATOR

Federal University of Rio Grande do Sul

Locations

Hospital de Clinicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Hospital de Clinicas e Porto Alegre (HCPA)

Porto Alegre, Rio Grande do Sul, Brazil

Countries

Brazil

References

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Reference Type: RESULT

PMID: 25287554 (View on PubMed)

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Reference Type: RESULT

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Reference Type: RESULT

PMID: 30022928 (View on PubMed)

Fregni F, Boggio PS, Mansur CG, Wagner T, Ferreira MJ, Lima MC, Rigonatti SP, Marcolin MA, Freedman SD, Nitsche MA, Pascual-Leone A. Transcranial direct current stimulation of the unaffected hemisphere in stroke patients. Neuroreport. 2005 Sep 28;16(14):1551-5. doi: 10.1097/01.wnr.0000177010.44602.5e.

Reference Type: RESULT

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Beltran Serrano G, Pooch Rodrigues L, Schein B, Zortea M, Torres ILS, Fregni F, Caumo W. The Hypnotic Analgesia Suggestion Mitigated the Effect of the Transcranial Direct Current Stimulation on the Descending Pain Modulatory System: A Proof of Concept Study. J Pain Res. 2020 Sep 16;13:2297-2311. doi: 10.2147/JPR.S253747. eCollection 2020.

Reference Type: DERIVED

PMID: 32982393 (View on PubMed)

Beltran Serrano G, Rodrigues LP, Schein B, Souza A, Torres ILS, da Conceicao Antunes L, Fregni F, Caumo W. Comparison of Hypnotic Suggestion and Transcranial Direct-Current Stimulation Effects on Pain Perception and the Descending Pain Modulating System: A Crossover Randomized Clinical Trial. Front Neurosci. 2019 Jun 26;13:662. doi: 10.3389/fnins.2019.00662. eCollection 2019.

Reference Type: DERIVED

PMID: 31297046 (View on PubMed)

Other Identifiers

16-0635

Identifier Type: -

Identifier Source: org_study_id