Repetitive Transcranial Magnetic Stimulation Associated With Manual Therapy in Knee Ostearthritis Pain
NCT ID: NCT03076294
Last Updated: 2017-03-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
15 participants
INTERVENTIONAL
2017-01-31
2019-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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MT after rTMS group
High frequency TMS will be applied with an eight-shaped coil angled at zero degrees from the sagittal axis and positioned at the C3 or C4 in accordance with the international 10-20 marking system (JASPER, 1958), which corresponds to the right or left primary motor cortex (M1). Twenty four stimulus trains will be provided at 10 Hz for five seconds each. The interval between the trains will be 25 seconds, totaling 1200 pulses for approximately 12 minutes, with 90% of resting motor threshold (RMT). After TMS, patients will be submitted to 45 minutes of manual therapy protocol.
TMS
Repetitive TMS involves application of electric currents in the patient's cortex by a magnetic field applied to the scalp of the patient through an eight-coil connected to a magnetic stimulator (MagStim Rapid² magnetic stimulator-UK). In a small percentage of patients, it may cause minimal discomfort with a mild headache sensation, which usually disappears after a few seconds. Depending on the parameters, rTMS can increase or decrease corticomotor excitability and by the connection of the motor cortex with the thalamus, influencing pain control. The patients will respond to an adverse effects questionnaire and will report the perception of real or sham stimulation.
Manual therapy (MT)
This intervention uses manual contact for diagnosis and treatment, its practitioners use an enormous amount of manual techniques to preserve the homeostasis through the recovery of dysfunctions, which may cause limitations in the physiological movements, in the accessory movements of the joints (WHO , 2010).
rTMS after MT group
Patients will be submitted to 45 minutes of manual therapy protocol. After that, high frequency TMS will be applied with an eight-shaped coil angled at zero degrees from the sagittal axis and positioned at the C3 or C4 in accordance with the international 10-20 marking system (JASPER, 1958), which corresponds to the right or left primary motor cortex (M1). Twenty four stimulus trains will be provided at 10 Hz for five seconds each. The interval between the trains will be 25 seconds, totaling 1200 pulses for approximately 12 minutes, with 90% of resting motor threshold (RMT).
TMS
Repetitive TMS involves application of electric currents in the patient's cortex by a magnetic field applied to the scalp of the patient through an eight-coil connected to a magnetic stimulator (MagStim Rapid² magnetic stimulator-UK). In a small percentage of patients, it may cause minimal discomfort with a mild headache sensation, which usually disappears after a few seconds. Depending on the parameters, rTMS can increase or decrease corticomotor excitability and by the connection of the motor cortex with the thalamus, influencing pain control. The patients will respond to an adverse effects questionnaire and will report the perception of real or sham stimulation.
Manual therapy (MT)
This intervention uses manual contact for diagnosis and treatment, its practitioners use an enormous amount of manual techniques to preserve the homeostasis through the recovery of dysfunctions, which may cause limitations in the physiological movements, in the accessory movements of the joints (WHO , 2010).
Control group
In this group, the order of interventions will be randomized. Therefore, the volunteer can start with manual therapy or sham TMS. In manual therapy, patients will be submitted to 45 minutes of a protocol. In addition, with regard to sham TMS, the same parameters will be used, however, it will be performed using two coils, one connected to the magnetic stimulator, away from the patient's scalp and another uncoupled from the stimulator and positioned in the same way as in real stimulation.
TMS
Repetitive TMS involves application of electric currents in the patient's cortex by a magnetic field applied to the scalp of the patient through an eight-coil connected to a magnetic stimulator (MagStim Rapid² magnetic stimulator-UK). In a small percentage of patients, it may cause minimal discomfort with a mild headache sensation, which usually disappears after a few seconds. Depending on the parameters, rTMS can increase or decrease corticomotor excitability and by the connection of the motor cortex with the thalamus, influencing pain control. The patients will respond to an adverse effects questionnaire and will report the perception of real or sham stimulation.
Manual therapy (MT)
This intervention uses manual contact for diagnosis and treatment, its practitioners use an enormous amount of manual techniques to preserve the homeostasis through the recovery of dysfunctions, which may cause limitations in the physiological movements, in the accessory movements of the joints (WHO , 2010).
Interventions
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TMS
Repetitive TMS involves application of electric currents in the patient's cortex by a magnetic field applied to the scalp of the patient through an eight-coil connected to a magnetic stimulator (MagStim Rapid² magnetic stimulator-UK). In a small percentage of patients, it may cause minimal discomfort with a mild headache sensation, which usually disappears after a few seconds. Depending on the parameters, rTMS can increase or decrease corticomotor excitability and by the connection of the motor cortex with the thalamus, influencing pain control. The patients will respond to an adverse effects questionnaire and will report the perception of real or sham stimulation.
Manual therapy (MT)
This intervention uses manual contact for diagnosis and treatment, its practitioners use an enormous amount of manual techniques to preserve the homeostasis through the recovery of dysfunctions, which may cause limitations in the physiological movements, in the accessory movements of the joints (WHO , 2010).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Absence of severe cognitive deficiency verified by the Mini Mental State Examination;
* Meet the American College of Rheumatology criteria for idiopathic knee osteoarthritis.
Exclusion Criteria
* Had an opioid or corticosteroid injection in the last 30 days;
* Modified chronic pain medication in the last month before participating in the study;
* History of knee surgery in the last six months;
* Obese;
* Contraindications to the use of non-invasive brain stimulation, such as: metal implant on face or skull, history of seizure, cochlear implant.
50 Years
70 Years
ALL
No
Sponsors
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Universidade Federal de Pernambuco
OTHER
Responsible Party
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Kátia Monte-Silva
PhD
Principal Investigators
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Kátia Monte-Silva, PhD
Role: STUDY_DIRECTOR
Applied Neuroscience Laboratory, Universidade Federal de Pernambuco
Locations
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Applied Neuroscience Laboratory, Universidade Federal de Pernambuco
Recife, Pernambuco, Brazil
Kinesiotherapy and manual therapeutic resources laboratory
Recife, Pernambuco, Brazil
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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OA_TMS_Pain
Identifier Type: -
Identifier Source: org_study_id
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