Fibromyalgia Clinical Trial
Official title:
Effect of Transcranial Direct Current Stimulation Associated With Aerobic Exercise Training for Patients With Fibromyalgia
This study consists of a randomized, double-blind, clinical trial with two months' duration of follow-up. The variable used was the VAS for pain, considering the values of any difference between the data before and after stimulation.
Status | Completed |
Enrollment | 45 |
Est. completion date | November 2014 |
Est. primary completion date | November 2014 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: 1. Patients diagnosed with Fibromyalgia according to the American College of Rheumatology 2. Have completed high school 3. Age between 18 and 65 years old Exclusion Criteria: 1. Were on medication for pain control for less than two months 2. In treatment of depression for less than two months 3. Patients with epilepsy, psychiatric disorders or who have any recent episode of neurologic disorders such as idiopathic syncope 4. Pregnant women and infants 5. Possessing metallic implant in the brain 6. In use of illicit drugs 7. That were in some kind of physical treatment for less than two months |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
University of Sao Paulo General Hospital | University of Nove de Julho |
Fregni F, Gimenes R, Valle AC, Ferreira MJ, Rocha RR, Natalle L, Bravo R, Rigonatti SP, Freedman SD, Nitsche MA, Pascual-Leone A, Boggio PS. A randomized, sham-controlled, proof of principle study of transcranial direct current stimulation for the treatme — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Change in Pressure Pain Threshold (PPT) | Using a pressure algometer (Wagner Instruments, USA), pressure is measured in the thenar region of the hand and at the uppermost portion of the anterior tibialis muscle. Pressure is held until the individual report onset of pain. At this time the amount of compression performed in kg/force is measured. Outcome will be measured after one week of intervention, after four weeks of intervention, after 1 month of the end of protocol and 2 months after the end of protocol, for evaluation of long term effects. | Up to 2 months | No |
Other | Change in Diffuse Noxious Inhibitory Control (DNIC-like effects) | This parameter assesses through intense heterotopic stimulation, the response of endogenous pain modulation. Subjects emerge the hand in a container with ice-water (10-12°C) for a period of one minute. During the last 30 seconds of immersion, the pressure pain threshold is measured in the other hand. The same procedure is performed for the other side. Temperature is measured by an immersion thermometer (ALLA BRAZIL 910.0150L). Outcome will be measured after four weeks of intervention, after 1 month of the end of protocol and 2 months after the end of protocol, for evaluation of long term effects. | Up to 2 months | No |
Other | Change in SF-36 questionnaire of quality of life | This questionnaire evaluates different aspects in individual life such as: Vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, and mental health. Through different questions a score is generated for each subscale where zero represents the worst quality of life and 100 the best quality of life. Outcome will be measured after four weeks of intervention, after 1 month of the end of protocol and 2 months after the end of protocol, for evaluation of long term effects. | Up to 2 months | No |
Primary | Change in Visual Numeric Scale (VNS) | Pain intensity is measured using a scale from 0 to 10. A straight 10 cm line is displayed for the subject enumerated from zero to 10, where zero represents no pain and 10 the worst pain possible. Subjects should mark the number that most represents the symptom of pain at the moment. Outcome will be measured 24 hours after each intervention session, after 1 month of the end of protocol and 2 months after the end of protocol for evaluation of long term effects. | Up to 2 months | No |
Secondary | Change in Visual Numeric Scale for Anxiety | This scale has a straight 10 cm enumerated from zero to 10, where zero represents not anxious and 10 the most anxious possible. Subjects should mark the number that most represents the anxiety level at the moment. Outcome will be measured 24 hours after each intervention session, after 1 month of the end of protocol and 2 months after the end of protocol for evaluation of long term effects. | Up to 2 months | No |
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 |