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Completed

NCT Number: NCT03744897

Effect of Hypnosis Combined to Transcranial Direct Stimulation in Pain

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).

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Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hospital de Clinicas de Porto Alegre, Porto Alegre, Rio Grande do Sul, Brazil

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Hypnotic analgesia

Behavioral

Subjects will receive hypnotic analgesia during 20 minutes

a-tDCS

Device

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

Hypnotic analgesia + a-tDCS

Other

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

s-tDCS

Device

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

Primary outcomes

  1. Change in Alpha waves

    Time frame: 60 minutes

    Variations in the alpha waves power from post to pre-intervention using electroencephalography during a cold pressor test

  2. Change in Theta waves

    Time frame: 60 minutes

    Variations in the theta waves power from post to pre-intervention using electroencephalography during a cold pressor test

Secondary outcomes

  1. Change in beta waves

    Time frame: 60 minutes

    Variations in the beta waves power from post to pre-intervention using electroencephalography during a cold pressor test

  2. Change in gamma waves

    Time frame: 60 minutes

    Variations in the gamma waves power from post to pre-intervention using electroencephalography during a cold pressor test

  3. Change in delta waves

    Time frame: 60 minutes

    Variations in the delta waves power from post to pre-intervention using electroencephalography during a cold pressor test

  4. Change in Heat thermal threshold

    Time frame: 60 minutes

    The measure will be assessed by Quantitative Sensorial Test - QST, in which a thermode delivers a heat stimulus of increasing magnitude. Heat thermal threshold (HTT) is the averaged temperature for 3 stimuli where participant indicates the first heat sensation.

  5. Change in Heat pain threshold

    Time frame: 60 minutes

    The measure will be assessed by Quantitative Sensorial Test - QST, in which a thermode delivers a heat stimulus of increasing magnitude. Heat pain threshold (HPT) is the averaged temperature for 3 stimuli where participant indicates the first heat pain sensation.

  6. Change in Heat pain tolerance

    Time frame: 60 minutes

    The measure will be assessed by Quantitative Sensorial Test - QST, in which a thermode delivers a heat stimulus of increasing magnitude. Heat pain tolerance (HPTo) is the temperature for the stimulus where participant indicates the maximum pain tolerance.

  7. Change in Numeric pain scale during CPM task

    Time frame: 60 minutes

    The measure will be assessed by the conditioned pain modulation (CPM) task in which an ice cold water (0 a 1 degrees Celsius) is the conditioning stimulus presented to the left hand and a moderate heat pain stimulus from the QST to the contralateral hand. The measure consists of the response using a numeric pain scale (0 - 10) for the heat pain stimulus during the CPM task.

  8. Change in Cold Pressor Test 0 to 1 degree Celsius - time

    Time frame: 60 minutes

    Participant puts his right hand in an ice cold water (0 a 1 degrees Celsius). Measure consists of the time (in seconds) the participant keeps his hand in the water the maximum he could tolerance.

  9. Change in Cold Pressor Test 10 degree Celsius - time

    Time frame: 60 minutes

    Participant puts his right hand in an ice cold water (10 degrees Celsius). Measure consists of the time (in seconds) the participant keeps his hand in the water the maximum he could tolerate.

  10. Change in Cold Pressor Test 10 degree Celsius - pain

    Time frame: 60 minutes

    Participant puts his right hand in an ice cold water (10 degrees Celsius). Measure consists of the response to a numeric pain scale (0 to 10) to the pain sensation when the participant withdraw his hand from the water.

Sponsors and collaborators

Lead sponsor

Hospital de Clinicas de Porto Alegre

Other

Registry information

Official study title

Effect of Hypnosis Combined to Transcranial Direct Stimulation in Cortical Activity and Pain Perception in Healthy Females

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Nov 19, 2018
Registry last updated
Nov 26, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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