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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| tDCS Active vs TENS Active | Experimental |
| |
| tDCS Active vs TENS Placebo | Experimental |
| |
| tDCS Placebo vs TENS Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| transcranial direct current stimulation (tDCS) | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Chronic Knee Pain | The Visual Analogic Scale will be used to assess the impact on chronic knee pain. The values range from 0 to 10 (0 = No pain, 10 = the worst pain). | Through study completion, an average of 1 year. |
| Measure | Description | Time Frame |
|---|---|---|
| Function and Quality of Life | The Western Ontario and McMaster (WOMAC) scale will be used to assess pain, function, and quality of life in knee osteoarthritis and range from 0 to 96 (higher score, worst outcome). | Through study completion, an average of 1 year. |
| Force |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joaquina JM Montilla, PhD, PT | Director | Study Director |
| Mariano MG Gacto, PhD, PT | Co-Director | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Murcia | Murcia | 30100 | Spain |
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|
| TENS | 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 | 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. |
|
Using a dynamometer for quadriceps muscle (measurement in Kg, higher score means better outcome). |
| Through study completion, an average of 1 year. |
| Balance | A short physical performance battery (SPPB) will be used to measure balance. SPPB ranges from 0 (worst) to 12 (best). | Through study completion, an average of 1 year. |
| Gait properties. | 6 Minutes Walk Test (meters) measure exercise tolerance, less than 350 meters is high risk of death in some patients. More meters, more score. | Through study completion, an average of 1 year. |
| Coordination and Balance | Timed Up and Go Test (TUG), less than 10 seconds (low risk of falls) more than 20 seconds (high risk of falls). | Through study completion, an average of 1 year. |
| Uncertainly | Mishel's Uncertainly Scale (MUIS) range from 55 to 121 (more score, greater uncertainly, worst outcome). | Through study completion, an average of 1 year. |
| Catastrophizing | The Pain Catastrophizing Scale (PCS) range from 0 to 52 (more score, greater catastrophizing, worst outcome). | Through study completion, an average of 1 year. |
| Kinesiophobia | The Tampa Scale of Kinesiophobia (TSK) range from 11 to 44 (higher values are worst outcome). | Through study completion, an average of 1 year. |
| Central Sensitization | 8Central Sensitization Inventory (CSI) range from 0 to 100 (higher values are worst outcome) | Through study completion, an average of 1 year. |
| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D065908 | Transcranial Direct Current Stimulation |
| D004561 | Transcutaneous Electric Nerve Stimulation |
| D015444 | Exercise |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D003295 | Convulsive Therapy |
| D013000 | Psychiatric Somatic Therapies |
| D004191 | Behavioral Disciplines and Activities |
| D004597 | Electroshock |
| D011580 | Psychological Techniques |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
| D000698 | Analgesia |
| D000760 | Anesthesia and Analgesia |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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