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

Universidade Federal de Pernambuco

Status and phase: Unknown; Phase 2

Conditions: Knee Osteoarthritis

Treatments: Other: Manual therapy (MT); Device: TMS

Study type: Interventional

Funder types: Other

Identifiers

NCT03076294

OA_TMS_Pain

Details and patient eligibility

About

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.

Enrollment: 15 estimated patients

Sex: All

Ages: 50 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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15 participants in 3 patient groups

MT after rTMS group

Experimental group

Description:

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.

Treatment:

Device: TMS

Other: Manual therapy (MT)

rTMS after MT group

Experimental group

Description:

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).

Treatment:

Device: TMS

Other: Manual therapy (MT)

Control group

Sham Comparator group

Description:

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.

Treatment:

Device: TMS

Other: Manual therapy (MT)