Clinical trial NCT05066568: Effect of Hypnosis Combined With Tdcs on Pain Perception and Cortical Excitability in Fibromyalgia
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Transcranial Direct Current Stimulation
Hypnosis
Fibromyalgia
Keywords: chronic pain
fibromyalgia
hypnotic analgesia
tDCS
DPMS
Cold pressor test
Lead sponsor: Hospital de Clinicas de Porto Alegre
Sponsor class: OTHER
First posted: 2021-10-04
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: Design: Randomized blinded factorial sham controlled clinical trial
Primary purpose: OTHER

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Changes in Pain Levels during Cold Pressor Test from Pre to Post Interventions
timeFrame: First assessed 40 minutes Pre interventions and 70 minutes post interventions
measure: Changes in Pain Tolerance during Cold Pressor Test from Pre to Post Interventions
timeFrame: First assessed 40 minutes Pre interventions and again 70 minutes post interventions
measure: Changes in Short Cortical Inhibition during Transcranial Magnetic Stimulation from pre to post interventions
timeFrame: First assessed 10 minutes Pre intervention and again 20 minutes post intervention
Secondary outcomes:
measure: Changes in Numerical Pain Scale during Conditioned Pain Modulation-task from Pre to Post Interventions
timeFrame: First assessed 50 minutes pre interventions and again 1 hour post interventions
measure: Changes in Motor Threshold from Pre to Post Interventions
timeFrame: First assessed 30 minutes Pre interventions and again immediately post interventions
measure: Changes in Motor Evoked Potential from Pre to Post Interventions
timeFrame: First assessed 25 minutes Pre interventions and again 5 minutes post interventions
measure: Changes in Silent Period from Pre to Post Interventions
timeFrame: First assessed 5 minutes Pre Interventions and again 25 minutes post interventions
measure: Changes in Intra-cortical Facilitation from Pre to Post Interventions
timeFrame: First assessed 10 minutes Pre intervention and again 20 minutes post intervention
Other outcomes:
measure: Pain Catastrophizing Scale
timeFrame: 5 minutes
measure: Pittsburgh Sleep Quality Index
timeFrame: 5 minutes
measure: Beck Depression Inventory II
timeFrame: 5 minutes
measure: State-Trait Anxiety Inventory
timeFrame: 5 minutes
measure: Central Sensitization Inventory
timeFrame: 5 minutes
Locations:
city: Porto Alegre
country: Brazil
facility: Hospital de Clínicas de Porto Alegre
state: Rio Grande Do Sul
Study officials:
affiliation: Federal University of Rio Grande do Sul
name: Wolnei Caumo, PhD
role: PRINCIPAL_INVESTIGATOR
References: