Effect of Hypnosis Combined With Tdcs on Pain Perception and Cortical Excitability in Fibromyalgia

NCT05066568 | Unknown DMC

• 1 other identifier: 2019-0688
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Transcranial Direct Current Stimulation; Hypnosis; Fibromyalgia

Keywords

chronic pain; fibromyalgia; hypnotic analgesia; tDCS; DPMS; Cold pressor test

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  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

  First assessed 50 minutes pre interventions and again 1 hour post interventions

• Changes in Motor Threshold from Pre to Post Interventions

  First assessed 30 minutes Pre interventions and again immediately post interventions

• Changes in Motor Evoked Potential from Pre to Post Interventions

  First assessed 25 minutes Pre interventions and again 5 minutes post interventions

• Changes in Silent Period from Pre to Post Interventions

  First assessed 5 minutes Pre Interventions and again 25 minutes post interventions

• Changes in Intra-cortical Facilitation from Pre to Post Interventions

  First assessed 10 minutes Pre intervention and again 20 minutes post intervention

Other Outcomes (5)

• Pain Catastrophizing Scale

  5 minutes

• Pittsburgh Sleep Quality Index

  5 minutes

• Beck Depression Inventory II

  5 minutes

Study Arms (2)

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

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.

Device: Active Tracranial Direct Current Stimulation; Other: Hypnotic analgesia suggestion; Behavioral: Rest; Other: Active tDCS + Hypnotic analgesia suggestion; Other: Sham tDCS + Hypnotic analgesia suggestion

Interventions

Active Tracranial Direct Current Stimulation DEVICE

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.

Also known as: a-tDCS

Sequence of interventions starting with Hypnosis as the first intervention; Sequence of interventions starting with tDCS as the first intervention

Hypnotic analgesia suggestion OTHER

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.

Also known as: Hypnosis

Sequence of interventions starting with Hypnosis as the first intervention; Sequence of interventions starting with tDCS as the first intervention

Rest BEHAVIORAL

The patient is asked to remain seated still for 20 minutes.

Sequence of interventions starting with Hypnosis as the first intervention; Sequence of interventions starting with tDCS as the first intervention

Active tDCS + Hypnotic analgesia suggestion OTHER

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.

Also known as: a-tDCS+HS

Sequence of interventions starting with Hypnosis as the first intervention; Sequence of interventions starting with tDCS as the first intervention

Sham tDCS + Hypnotic analgesia suggestion OTHER

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.

Also known as: s-tDCS+HS

Sequence of interventions starting with Hypnosis as the first intervention; Sequence of interventions starting with tDCS as the first intervention

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Hospital de Clinicas de Porto Alegre: lead

Study Sites (1)

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90035-003, Brazil

RECRUITING

Related Publications (1)

• 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.

  PMID: 36718400 DERIVED

MeSH Terms

Conditions

Fibromyalgia; Chronic Pain

Interventions

Hypnosis; RE1-silencing transcription factor

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Wolnei Caumo, PhD

  Federal University of Rio Grande do Sul

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wolnei Caumo, PHD

CONTACT

55 51 33596377; wcaumo@hcpa.edu.br

Bruno Schein Cavalheiro Corrêa, Bachelor

CONTACT

55 51 9999664457; schein.bruno@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Blinding: The researcher will receive a device previously programmed by a research assistant. This way the researcher that perform the Transcranial direct current stimulation does not know if it's a active or sham intervention. The subjects will also be blinded to the nature of the stimulation. The subjects will be asked to answer what intervention they think they recieved after each one of the tDCS sessions.
• Purpose: OTHER
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Design: Randomized blinded factorial sham controlled clinical trial

Study Record Dates

• First Submitted: August 23, 2021
• First Posted: October 4, 2021
• Study Start: July 2, 2020
• Primary Completion: October 30, 2021
• Study Completion: December 30, 2021
• Last Updated: October 4, 2021

Record last verified: 2021-09

Locations

BR (1)