Fibromyalgia Clinical Trial
Official title:
Pregabalin Acute Effects on Cortical Excitability, Psychophysical Parameters, and Serum Markers of Neuroplastic Processes in Fibromyalgia: a Placebo Controlled, Double Blinded, Randomized, Crossover Clinical Trial
Fibromyalgia syndrome represents a "spectrum disorder" characterized by widespread chronic
pain, fatigue, sleep disturbances, mood and cognitive alterations. The most accepted models
explaining the causes of the disease have focused on the reduced pain inhibitory systems
activity, that allow low intensity stimuli to be processed easier, and that finally amplify
pain stimuli. One of the interventions approved for Fibromyalgia is Pregabalin, which
demonstrated to be effective reducing pain. Different studies in animals have shown that it
works reducing the liberation of neuronal messengers, which slow the conduction of pain
signals. Although studies in humans have confirmed Pregabalin clinical benefits, there are
still few studies aiming to explain how it actually works in patients with fibromyalgia,
though.
A better understanding of the mechanisms by which Pregabalin reduces pain in patients with
fibromyalgia would allow designing new interventions to enhance its clinical effects. Thus,
the investigators propose to study in real-time the electrical, vascular and hormonal
response of the brain of patients with fibromyalgia who receive a single dose of Pregabalin.
The vascular response will be assessed using functional near infrared spectroscopy (fNIRS)
neuroimaging techniques. The electrical response will be assessed using Transcranial Magnetic
Stimulation (TMS). The hormonal response will be assessed in blood, measuring neurotrophins
(Brain Derived Neurotrophic Factor) and inflammatory mediators (Tumor Necrosis Factor). These
responses will be studied in consideration of the patients' characteristics that will be
assessed using validated scales.
Taken into account the above considerations, a crossover, double-blinded randomized clinical
trial is proposed. In the investigators' study, patients and healthy volunteers will be asked
to visit the investigators' laboratory in three opportunities: one for a baseline assessment,
and the other two to test the effects of either Pregabalin 150 mg PO or Placebo. All
participants will eventually receive both, Pregabalin and Placebo. In each visit a brain
hemodynamic, electrical, hormonal and clinical evaluation will be performed.
A crossover, double-blinded randomized clinical trial is proposed. The investigators will
recruit literate adult females aging 18 to 65 years old; fulfilling the diagnosis criteria
for fibromyalgia according to the American College of Rheumatology 2010; with mean pain ≥6 in
the verbal analog scale; who speak Brazilian Portuguese; and were able to perform the three
visits. Female adult participants without chronic pain will also be recruited. Participants
with severe psychiatric disorders that would limit consenting; neurologic deficits;
decompensated systemic disease or chronic inflammatory disorders (Systemic Erythematous Lupus
or Rheumatoid arthritis); contraindications for TMS; and those with previous use of
Pregabalin will be excluded.
In the investigators' study, participants will be asked to visit the investigators'
laboratory in three opportunities: one for a baseline assessment, and the other two to test
the effects of either Pregabalin 150 mg PO or Placebo. All participants will eventually
receive both, Pregabalin and Placebo. In each visit a brain hemodynamic, electrical, hormonal
and clinical evaluation will be performed.
In the first visit, after explaining the research, solving doubts and signing the informed
consent, participants will be randomized to an allocation sequence (either Pregabalin in the
second or in the third visit). Then, a blood sample will be gathered and participants will be
asked to fill some questionnaires to understand better their pain, and its impact on their
quality of life (Fibromyalgia Impact Questionnaire), Anxiety (State/Trait Anxiety Inventory),
Depressive symptoms (Beck Depression Inventory II), Catastrophizing thinking (Pain
Catastrophizing Scale - PCS), Sleep (Pittsburgh Sleep Quality Index), and resiliency. Then, a
fingertapping task will be performed while assessing hemodynamic changes using fNIRS. After
that, heat perception will be tested using quantitative sensory testing (QST) and Conditioned
Pain Modulation (CPM) with cold. Also, the pain pressure threshold (PPT) using a digital
algometer will be evaluated. Finally, cortical excitability parameters (motor evoked
potentials, intracortical facilitation and inhibition, and cortical silent period) will be
determined using paired pulsed TMS.
In the second visit, according to the randomized allocation participants will receive either
Pregabalin 150 mg PO or Placebo. Then, the M.I.N.I. International Neuropsychiatric Interview
will be performed. One hour after taking the medication, the fNIRS, QST, CPM, PPT and TMS
evaluations will be repeated, and a new blood sample will be collected. In the third visit, a
blood sample will be gathered, followed by administration of the corresponding intervention
according to the randomized allocation. Then, the pain level, PCS, STAI and International
Physical Activity Questionnaire (IPAQ) will be asked again. One hour after taking the
medication, the fNIRS, QST, CPM, PPT and TMS evaluations will be repeated, and a final blood
sample will be collected. Participants' guess about blinding will be assessed after each
intervention. All evaluators will remain blind to the allocation.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT05659862 -
Digitally Assisted Behavioral Physical Activity Intervention in Fibromyalgia
|
N/A | |
Recruiting |
NCT03207828 -
Testing Interventions for Patients With Fibromyalgia and Depression
|
N/A | |
Completed |
NCT03042728 -
Impact of Inclusion of a Therapy Dog Visit as Part of the Fibromyalgia Treatment Program
|
N/A | |
Recruiting |
NCT06097091 -
Effects and Mechanisms of Pain Neuroscience Education in Patients With Fibromyalgia
|
N/A | |
Recruiting |
NCT04554784 -
Effectiveness of Bowen Therapy for Pain Management in Patients With Fibromyalgia
|
N/A | |
Completed |
NCT03300635 -
Metabolism, Muscle Function and Psychological Factors in Fibromyalgia
|
N/A | |
Recruiting |
NCT06166563 -
Exercise, Irritable Bowel Syndrome and Fibromyalgia
|
N/A | |
Completed |
NCT03227952 -
Sensory Stimulation in Fibromyalgia
|
N/A | |
Completed |
NCT03166995 -
Postural Exercises in Women With Fibromyalgia
|
N/A | |
Recruiting |
NCT06237595 -
Vagus Nerve Stimulation in Fibromyalgia
|
N/A | |
Completed |
NCT01888640 -
Fibromyalgia Activity Study With Transcutaneous Electrical Nerve Stimulation (FAST)
|
N/A | |
Completed |
NCT03641495 -
Pain Education and Therapeutic Exercise for Fibromyalgia
|
N/A | |
Recruiting |
NCT05581628 -
FREQUENCY OF FIBROMYALGIA IN PATIENTS WITH CELIAC DISEASE
|
||
Active, not recruiting |
NCT05128162 -
Open-label Study to Assess the Safety and Efficacy of Psilocybin With Psychotherapy in Adult Participants With Fibromyalgia
|
Phase 2 | |
Completed |
NCT04674878 -
Comparison of Muscle Energy Techniques and Breathing Exercises for Functional Improvement in Fibromyalgia
|
N/A | |
Active, not recruiting |
NCT04084795 -
Augmentation of EMDR With tDCS in the Treatment of Fibromyalgia
|
N/A | |
Completed |
NCT03129906 -
Impact of the Restriction of Sources of Gluten in Fibromyalgia Patients
|
N/A | |
Completed |
NCT05058911 -
Exposure-based Cognitive Behavior Therapy vs Traditional Cognitive Behavior Therapy for Fibromyalgia
|
N/A | |
Recruiting |
NCT04571853 -
New Educational Tool for FM
|
N/A | |
Recruiting |
NCT04571528 -
Effectiveness of VIRTUAL FIBROWALK STUDY
|
N/A |