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

NCT ID: NCT05138471

Last Updated: 2024-05-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 65 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-17
• Study Completion Date: 2024-05-01

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.

Conditions

Osteo Arthritis Knee; Chronic Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

tDCS Active vs TENS Active

Group Type: EXPERIMENTAL

transcranial direct current stimulation (tDCS)

Intervention Type: DEVICE

tDCS intervention will consist in placing two electrodes, the cathode on the supraorbital surface on the same side as the painful knee, and the anode on the parietal area, corresponding to the area of the primary motor cortex, on the opposite side. The intensity will be 2 milli amperes (mA) and stimulation will be 20 minutes. The placebo will generate an initial sensation, and then descend until the stimulation is turned off.

TENS

Intervention Type: DEVICE

TENS intervention will consist in placing two electrodes on the sides of the patella of the affected knee. The frequency will be 10Herzts and the intensity will remain at a sensitive threshold level, without reaching the motor. The placebo will generate a sensation of current to descend to the minimum value that the equipment allows. Stimulation will last for 20 minutes.

Exercise and General Education

Intervention Type: BEHAVIORAL

The General Education Intervention consisting in an educational program will be applied to all groups using audiovisual material to increase the subject's knowledge about his/her pathology, about chronic pain and recommendations for supervised exercise based on the NEMEX protocol for osteoarthritis (Ageberg et al.)18: the participants will be taught analytical strengthening exercises (quadriceps and hamstrings) and neuromuscular functional exercises (getting up from the chair or going up a step), with their detailed dosage (2 to 3 series with 10 to 15 repetitions) and a home follow-up model where the participant must record compliance with exercise as well as pain during activity.

tDCS Active vs TENS Placebo

Group Type: EXPERIMENTAL

transcranial direct current stimulation (tDCS)

Intervention Type: DEVICE

tDCS intervention will consist in placing two electrodes, the cathode on the supraorbital surface on the same side as the painful knee, and the anode on the parietal area, corresponding to the area of the primary motor cortex, on the opposite side. The intensity will be 2 milli amperes (mA) and stimulation will be 20 minutes. The placebo will generate an initial sensation, and then descend until the stimulation is turned off.

Exercise and General Education

Intervention Type: BEHAVIORAL

The General Education Intervention consisting in an educational program will be applied to all groups using audiovisual material to increase the subject's knowledge about his/her pathology, about chronic pain and recommendations for supervised exercise based on the NEMEX protocol for osteoarthritis (Ageberg et al.)18: the participants will be taught analytical strengthening exercises (quadriceps and hamstrings) and neuromuscular functional exercises (getting up from the chair or going up a step), with their detailed dosage (2 to 3 series with 10 to 15 repetitions) and a home follow-up model where the participant must record compliance with exercise as well as pain during activity.

tDCS Placebo vs TENS Placebo

Group Type: PLACEBO_COMPARATOR

Exercise and General Education

Intervention Type: BEHAVIORAL

The General Education Intervention consisting in an educational program will be applied to all groups using audiovisual material to increase the subject's knowledge about his/her pathology, about chronic pain and recommendations for supervised exercise based on the NEMEX protocol for osteoarthritis (Ageberg et al.)18: the participants will be taught analytical strengthening exercises (quadriceps and hamstrings) and neuromuscular functional exercises (getting up from the chair or going up a step), with their detailed dosage (2 to 3 series with 10 to 15 repetitions) and a home follow-up model where the participant must record compliance with exercise as well as pain during activity.

Interventions

transcranial direct current stimulation (tDCS)

tDCS intervention will consist in placing two electrodes, the cathode on the supraorbital surface on the same side as the painful knee, and the anode on the parietal area, corresponding to the area of the primary motor cortex, on the opposite side. The intensity will be 2 milli amperes (mA) and stimulation will be 20 minutes. The placebo will generate an initial sensation, and then descend until the stimulation is turned off.

Intervention Type: DEVICE

TENS

TENS intervention will consist in placing two electrodes on the sides of the patella of the affected knee. The frequency will be 10Herzts and the intensity will remain at a sensitive threshold level, without reaching the motor. The placebo will generate a sensation of current to descend to the minimum value that the equipment allows. Stimulation will last for 20 minutes.

Intervention Type: DEVICE

Exercise and General Education

The General Education Intervention consisting in an educational program will be applied to all groups using audiovisual material to increase the subject's knowledge about his/her pathology, about chronic pain and recommendations for supervised exercise based on the NEMEX protocol for osteoarthritis (Ageberg et al.)18: the participants will be taught analytical strengthening exercises (quadriceps and hamstrings) and neuromuscular functional exercises (getting up from the chair or going up a step), with their detailed dosage (2 to 3 series with 10 to 15 repetitions) and a home follow-up model where the participant must record compliance with exercise as well as pain during activity.

Intervention Type: BEHAVIORAL

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).

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universidad de Murcia

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Joaquina JM Montilla, PhD, PT

Role: STUDY_DIRECTOR

Director

Mariano MG Gacto, PhD, PT

Role: STUDY_DIRECTOR

Co-Director

Locations

University of Murcia

Murcia, , Spain

Countries

Spain

Other Identifiers

JOS-2021-01

Identifier Type: -

Identifier Source: org_study_id