Effect of Hypnosis Combined With Tdcs on Pain Perception and Cortical Excitability in Fibromyalgia
NCT05066568 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20
Last updated 2021-10-04
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
Interventions
- 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.
Sponsors & Collaborators
-
Hospital de Clinicas de Porto Alegre
lead OTHER
Principal Investigators
-
Wolnei Caumo, PhD · Federal University of Rio Grande do Sul
Study Design
- Allocation
- RANDOMIZED
- Purpose
- OTHER
- Masking
- TRIPLE
- Model
- FACTORIAL
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-07-02
- Primary Completion
- 2021-10-30
- Completion
- 2021-12-30
Countries
- Brazil
Study Locations
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