Have you or your loved ones been diagnosed with knee osteoarthritis?

You may be eligible to participate in a knee osteoarthritis clinical trial.

Have you or your loved ones been diagnosed with knee osteoarthritis? You may be eligible to participate in a knee osteoarthritis clinical trial.

What is a clinical trial? Is participating in a clinical trial right for you? Learn more

Knee Osteoarthritis Clinical Trial

NCT03076294 | Phase 2 | Interventional

Have you or your loved ones been diagnosed with knee osteoarthritis?

You may be eligible to participate in a knee osteoarthritis clinical trial.

Have you or your loved ones been diagnosed with knee osteoarthritis? You may be eligible to participate in a knee osteoarthritis clinical trial.

Recruiting

Male & Female

50 - 70

Years old

This study is looking to recruit 15 Participants

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.

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Details for the study

Brief Title

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

Official Title

Brief Summary

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.

Treatments and/or Procedures

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).

Outcome Measures

Outcome measures are the tests that investigators perform to prove whether or not a treatment being tested in a clinical trial is having any effect.

Primary

Pain

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)

Primary

Pain Rating Scale (NPRS)

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

Cortical excitability

The motor evoked potential (MEP) will be provided by twenty unconditioned stimuli (120% of motor resting threshould).

One day (before and after the interventions)

Study 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.