Fibromyalgia Clinical Trial
Official title:
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
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.
Status | Recruiting |
Enrollment | 20 |
Est. completion date | December 30, 2021 |
Est. primary completion date | October 30, 2021 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
Brazil | Hospital de Clínicas de Porto Alegre | Porto Alegre | Rio Grande Do Sul |
Lead Sponsor | Collaborator |
---|---|
Hospital de Clinicas de Porto Alegre |
Brazil,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Pain Catastrophizing Scale | Measure of confounding factors | 5 minutes | |
Other | Pittsburgh Sleep Quality Index | Measure of confounding factors | 5 minutes | |
Other | Beck Depression Inventory II | Measure of confounding factors | 5 minutes | |
Other | State-Trait Anxiety Inventory | Measure of confounding factors | 5 minutes | |
Other | Central Sensitization Inventory | Measure of confounding factors | 5 minutes | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | Changes in Numerical Pain Scale during Conditioned Pain Modulation-task from Pre to Post Interventions | Descending pain modulation system assessed by Conditioned Pain Modulation task. The subject will be asked to put her non-dominant hand in a bucket with cold water at 0 degrees celsius. The other forearm will receive a painful heat stimuli using a device. The CPM score is calculated using the difference between the mean pain of both arms during the outcome assessment. | First assessed 50 minutes pre interventions and again 1 hour post interventions | |
Secondary | Changes in Motor Threshold from Pre to Post Interventions | Motor Threshold assessed by Transcranial Magnetic Stimulation | First assessed 30 minutes Pre interventions and again immediately post interventions | |
Secondary | Changes in Motor Evoked Potential from Pre to Post Interventions | Motor Evoked Potential assessed by Transcranial Magnetic Stimulation | First assessed 25 minutes Pre interventions and again 5 minutes post interventions | |
Secondary | Changes in Silent Period from Pre to Post Interventions | Silent Period assessed by Transcranial Magnetic Stimulation | First assessed 5 minutes Pre Interventions and again 25 minutes post interventions | |
Secondary | Changes in Intra-cortical Facilitation from Pre to Post Interventions | Intra-cortical Facilitation assessed by Transcranial Magnetic Stimulation | First assessed 10 minutes Pre intervention and again 20 minutes post intervention |
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