Clinical trial NCT05138471: 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
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteo Arthritis Knee
Chronic Pain
Keywords: tDCS
transcranial direct current stimulation
knee osteoarthritis
TENS
chronic knee pain
Lead sponsor: Universidad de Murcia
Sponsor class: OTHER
First posted: 2021-12-01
Enrollment: 65
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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).

Primary outcomes:
measure: Chronic Knee Pain
timeFrame: Through study completion, an average of 1 year.
Secondary outcomes:
measure: Function and Quality of Life
timeFrame: Through study completion, an average of 1 year.
measure: Force
timeFrame: Through study completion, an average of 1 year.
measure: Balance
timeFrame: Through study completion, an average of 1 year.
measure: Gait properties.
timeFrame: Through study completion, an average of 1 year.
measure: Coordination and Balance
timeFrame: Through study completion, an average of 1 year.
measure: Uncertainly
timeFrame: Through study completion, an average of 1 year.
measure: Catastrophizing
timeFrame: Through study completion, an average of 1 year.
measure: Kinesiophobia
timeFrame: Through study completion, an average of 1 year.
measure: Central Sensitization
timeFrame: Through study completion, an average of 1 year.
Other outcomes:
Locations:
city: Murcia
country: Spain
facility: University of Murcia
Study officials:
affiliation: Director
name: Joaquina JM Montilla, PhD, PT
role: STUDY_DIRECTOR
affiliation: Co-Director
name: Mariano MG Gacto, PhD, PT
role: STUDY_DIRECTOR
References: