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

Knee Osteoarthritis Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03076294
• Other study ID #: OA_TMS_Pain
• Status: Recruiting
• Phase: Phase 2
• First received: March 6, 2017
• Last updated: March 6, 2017
• Start date: January 2017
• Est. completion date: March 2019

Study information

• Verified date: March 2017
• Source: Universidade Federal de Pernambuco
• Contact: Kátia Monte-Silva, PhD
• Phone: +55 81 988631322
• Email: monte.silvakk[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: March 2019
• Est. primary completion date: March 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

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:
• 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).

Locations

Country	Name	City	State
Brazil	Applied Neuroscience Laboratory, Universidade Federal de Pernambuco	Recife	PE
Brazil	Kinesiotherapy and manual therapeutic resources laboratory	Recife	PE

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Federal de Pernambuco

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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)