- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03076294
Repetitive Transcranial Magnetic Stimulation Associated With Manual Therapy in Knee Ostearthritis Pain
March 6, 2017 updated by: Kátia Monte-Silva, Universidade Federal de Pernambuco
In this study, the investigators wondered whether the association between high frequency repetitive transcranial magnetic stimulation (hf-rTMS) and manual therapy (peripheral and central approach) is more effective in reducing pain levels and modulation of cortical activity of chronic knee ostearthritis pain subjects than manual therapy alone (usual peripheral approach).
For this purpose, patients included will be submitted to one session with active or sham hf-rTMS followed by a protocol of manual therapy.
Besides that another active group will have the sequence of interventions exchanged (manual therapy followed by hf-rTMS) in order to investigate whether this may influence in the final outcomes.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
15
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Kátia Monte-Silva, PhD
- Phone Number: +55 81 988631322
- Email: monte.silvakk@gmail.com
Study Contact Backup
- Name: Mannaly Mendonça, PT
- Phone Number: +55 81 995554000
- Email: mannaly@gmail.com
Study Locations
-
-
PE
-
Recife, PE, Brazil, 50670-900
- Recruiting
- Applied Neuroscience Laboratory, Universidade Federal de Pernambuco
-
Contact:
- Déborah Marques, MSc
- Phone Number: +55 81 997479444
- Email: deby.marques@gmail.com
-
Contact:
- Sérgio Rocha, MSc
- Phone Number: +55 81 997708502
- Email: srocha3105@gmail.com
-
Sub-Investigator:
- Mannaly Mendonça, PT
-
Sub-Investigator:
- Déborah Marques, MSc
-
Recife, PE, Brazil, 50670-900
- Recruiting
- Kinesiotherapy and manual therapeutic resources laboratory
-
Contact:
- Maria das Graças Araújo, PhD
- Phone Number: +55 81 999729856
- Email: mgrodriguesaraujo@hotmail.com
-
Sub-Investigator:
- Maria das Graças Araújo, PhD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Diagnosis of knee OA;
- 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:
- Individuals diagnosed with osteoporosis, fibromyalgia or other neurological disease;
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
|
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.
Other Names:
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 Names:
|
Experimental: 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).
|
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.
Other Names:
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 Names:
|
Sham Comparator: 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.
|
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.
Other Names:
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 Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain
Time Frame: Until one day (before and after the interventions)
|
Pain will be evaluated by pressure algometry before and after the interventions.
It's a evaluation technique which aims to quantify through physical stimulation (pressure in the nociceptors) the capacity of pain perception and toleration.
It will be used with the patient lying in supine and will have the purpose of measure the pressure pain threshold (PPT) in eight points around patellar region.
Besides that, two control points will be adopted, one in anterior tibial muscle (five centimeters distal of anterior tibial tuberosity) and another in the extensor carpi radialis longus muscle (five centimeters distal to lateral humerus epicondyle).
After marking, the algometer will be setted up 90° in contact with the skin and will be applied a 0,3 kgf/cm²/s pressure until the patient report pain by pressing a pen (Model/Brand: Algomed/Medoc).
The measure will be done twice in the demarcated points with a two minutes interval between them.
Will be considered a mean of the obtained values.
|
Until one day (before and after the interventions)
|
Pain Rating Scale (NPRS)
Time Frame: Until 30 days (before, after the interventions and until the last day with the same value of the first evaluation)
|
Is it used to quantify pain level, where 0 means no pain and 10 means worst pain possible.
NPRS is recommended as the main endpoint in chronic pain studies and it has been established that a decrease of at least 2 points or 30% represents a minimal clinically important difference.
The MDCI consists of the smaller variation in a clinical outcome perceived by the patient and that results in a relevant change in his state of health.
|
Until 30 days (before, after the interventions and until the last day with the same value of the first evaluation)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cortical excitability
Time Frame: One day (before and after the interventions)
|
The motor evoked potential (MEP) will be provided by twenty unconditioned stimuli (120% of motor resting threshould).
|
One day (before and after the interventions)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2017
Primary Completion (Anticipated)
March 1, 2018
Study Completion (Anticipated)
March 1, 2019
Study Registration Dates
First Submitted
March 6, 2017
First Submitted That Met QC Criteria
March 6, 2017
First Posted (Actual)
March 10, 2017
Study Record Updates
Last Update Posted (Actual)
March 10, 2017
Last Update Submitted That Met QC Criteria
March 6, 2017
Last Verified
March 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- OA_TMS_Pain
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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