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Repetitive Transcranial Magnetic Stimulation Associated With Manual Therapy in Knee Ostearthritis Pain

This study is currently recruiting participants.
Verified March 2017 by Kátia Monte-Silva, Universidade Federal de Pernambuco
Sponsor:
ClinicalTrials.gov Identifier:
NCT03076294
First Posted: March 10, 2017
Last Update Posted: March 10, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Kátia Monte-Silva, Universidade Federal de Pernambuco
  Purpose
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.

Condition Intervention Phase
Knee Osteoarthritis Device: TMS Other: Manual therapy (MT) Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Kátia Monte-Silva, Universidade Federal de Pernambuco:

Primary Outcome Measures:
  • 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.

  • 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.


Secondary Outcome Measures:
  • 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).


Estimated Enrollment: 15
Study Start Date: January 2017
Estimated Study Completion Date: March 2019
Estimated Primary Completion Date: March 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Device: 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.
Other Name: non invasive brain stimulation, high frequency TMS
Other: 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 Name: Musculoskeletal manipulation
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).
Device: 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.
Other Name: non invasive brain stimulation, high frequency TMS
Other: 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 Name: Musculoskeletal manipulation
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.
Device: 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.
Other Name: non invasive brain stimulation, high frequency TMS
Other: 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 Name: Musculoskeletal manipulation

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03076294


Contacts
Contact: Kátia Monte-Silva, PhD +55 81 988631322 monte.silvakk@gmail.com
Contact: Mannaly Mendonça, PT +55 81 995554000 mannaly@gmail.com

Locations
Brazil
Applied Neuroscience Laboratory, Universidade Federal de Pernambuco Recruiting
Recife, PE, Brazil, 50670-900
Contact: Déborah Marques, MSc    +55 81 997479444    deby.marques@gmail.com   
Contact: Sérgio Rocha, MSc    +55 81 997708502    srocha3105@gmail.com   
Sub-Investigator: Mannaly Mendonça, PT         
Sub-Investigator: Déborah Marques, MSc         
Sub-Investigator: Sérgio Rocha, MSc         
Kinesiotherapy and manual therapeutic resources laboratory Recruiting
Recife, PE, Brazil, 50670-900
Contact: Maria das Graças Araújo, PhD    +55 81 999729856    mgrodriguesaraujo@hotmail.com   
Sub-Investigator: Maria das Graças Araújo, PhD         
Sponsors and Collaborators
Universidade Federal de Pernambuco
Investigators
Study Director: Kátia Monte-Silva, PhD Applied Neuroscience Laboratory, Universidade Federal de Pernambuco
  More Information

Responsible Party: Kátia Monte-Silva, PhD, Universidade Federal de Pernambuco
ClinicalTrials.gov Identifier: NCT03076294     History of Changes
Other Study ID Numbers: OA_TMS_Pain
First Submitted: March 6, 2017
First Posted: March 10, 2017
Last Update Posted: March 10, 2017
Last Verified: March 2017

Keywords provided by Kátia Monte-Silva, Universidade Federal de Pernambuco:
knee ostearthritis
transcranial magnetic stimulation
repetitive transcranial magnetic stimulation
chronic pain
musculoskeletal manipulations

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases