NCT05066568

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Hospital de Clinicas de Porto Alegre · Academic / Other
• Sex: Female
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Transcranial Direct Current Stimulation
• Hypnosis
• Fibromyalgia

Interventions

Type	Name	Description
DEVICE	Active Tracranial Direct Current Stimulation	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.
OTHER	Hypnotic analgesia suggestion	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.
BEHAVIORAL	Rest	The patient is asked to remain seated still for 20 minutes.
OTHER	Active tDCS + Hypnotic analgesia suggestion	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.
OTHER	Sham tDCS + Hypnotic analgesia suggestion	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.

Timeline

• Start date: 2020-07-02
• Primary completion: 2021-10-30
• Completion: 2021-12-30
• First posted: 2021-10-04
• Last updated: 2021-10-04

Locations

1 site across 1 country: Brazil