Addition of Transcranial Direct Current Stimulation and Transcutaneous Electrical Nerve Stimulation to an Education and Exercise Program in Subjects With Chronic Pain Due to Knee Osteoarthritis

Universidad de Murcia

Status: Completed

Conditions: Chronic Pain; Osteo Arthritis Knee

Treatments: Device: TENS; Device: transcranial direct current stimulation (tDCS); Behavioral: Exercise and General Education

Study type: Interventional

Funder types: Other

Identifiers

NCT05138471

JOS-2021-01

Details and patient eligibility

About

Knee osteoarthritis has a very high prevalence in the population over 50 years of age. Patients with osteoarthritis often suffer from chronic pain that becomes disabling, affecting both quality of life and mental and physical health. This pathology has also been linked to maladaptive plasticity in the brain, which can contribute to chronic pain. Therapies with neuromodulatory approaches, such as transcranial direct current stimulation (tDCS) and peripheral electrical stimulation (TENS), have been used therapeutically to counteract the maladaptive plasticity of the brain.

Transcranial therapy and TENS can be a possible effective treatment in the rehabilitation services of the health system for the improvement of chronic pain and quality of life in different pathologies, such as chronic low back pain, fibromyalgia or knee and hip osteoarthritis.

Enrollment: 65 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adults over fifty years of age with a diagnosis of knee osteoarthritis by radiography.
• Chronic pain of more than six months, compliance with the diagnostic criteria for knee osteoarthritis according to the Osteoarthritis Research Society International (OARSI) guideline:
• Pain in Analog Visual Scale more than 4/10
• Matutinal less than 30 minutes
• Absence of hyperthermia upon palpation in the joint
• Alteration of the bone image
• Crepitus

Exclusion criteria

• Patients who can provide low-quality or biased information discriminated by the Mini-Mental State Examination (Score less than 24).
• Severe hearing, visual or sensory impairment or comorbidities that prevent the correct completion of the questionnaires and mobility activities.
• Patients who have undergone knee replacement surgery on the contralateral knee.
• Patients who have received intervention (infiltration, blockages, etc...) in the last 6 weeks.
• Pain due to tendinopathy, knee fracture, low back pain radiating to the knee, or fibromyalgia.
• Patients who decline to participate out of fear or denial of therapy.
• Severe heart disease that prevent exercise.
• Body Mass Index above 45.
• Patients with neuropsychiatric disorders (schizophrenia, epilepsy or bipolar disorders) or taking medication for these conditions (antiepileptic drugs).
• Patients with metallic implants in the area (skull or knee).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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65 participants in 3 patient groups, including a placebo group

tDCS Active vs TENS Active

Experimental group

Treatment:

Behavioral: Exercise and General Education

Device: transcranial direct current stimulation (tDCS)

Device: TENS

tDCS Active vs TENS Placebo

Experimental group

Treatment:

Behavioral: Exercise and General Education

Device: transcranial direct current stimulation (tDCS)

tDCS Placebo vs TENS Placebo

Placebo Comparator group

Treatment:

Behavioral: Exercise and General Education