To analyze the effects of therapeutic exercise combined with noninvasive neuromodulation (NESA) or transcutaneous electrical nerve stimulation (TENS) on improving clinical symptoms such as joint pain and stiffness, as well as its impact on the functionality, mental health, and quality of life of people over 60 years of age with knee osteoarthritis.
A single-blind, randomized clinical trial with two intervention groups will be conducted. A pretest-posttest design will be used to evaluate individuals over 60 years of age. Participants will be divided into two groups: one group will receive an 8-week therapeutic exercise program combined with noninvasive neuromodulation (NESA); and the other group will receive the same therapeutic exercise program combined with transcutaneous electrical nerve stimulation (TENS) for 8 weeks. Variables will be measured for both groups using the same validated tools and by the same researchers to avoid information bias and differential misclassification. Assessments will be conducted at the beginning of the intervention and immediately after its completion. The results will be recorded in a database for analysis. For the independent variables, sociodemographic characteristics will be taken into account. The outcome variables will be divided by domain; pain will be assessed using the Numerical Pain Rating Scale (NPRS), which measures pain intensity. To assess the symptoms and functional capacity associated with knee osteoarthritis, the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) will be used. For the physical and functional assessment, the Timed Up and Go Test (TUG) will be used to assess functional mobility, balance, and agility. The Short Physical Performance Battery (SPPB) will be used to evaluate balance, gait, and strength/endurance. Balance and gait will also be assessed using the Tinetti Scale. Knee mobility will be measured with a mobile goniometry/inclinometer in flexion and extension. For strength, a dynamometer will be used to measure isometric strength of major knee movements. Among the psychosocial factors, catastrophizing will be measured with the PCS (Pain Catastrophizing) and kinesiophobia with the abbreviated version of the TSK-11 (Tampa Scale for Kinesiophobia). Fear of falling will be assessed using the Falls Efficacy Scale-International (FES-I). Quality of life will be measured using the Knee and Hip Osteoarthritis Quality of Life (OAKHQOL) questionnaire. Sleep quality will be measured using the Pittsburgh Index. The Hospital Anxiety and Depression Scale (HADS) will be used for anxiety and depression. Autonomic regulation will be assessed using heart rate variability. All variables will be measured pre- and post-intervention. As a result, a multimodal treatment is expected to significantly improve clinical symptoms associated with knee osteoarthritis, especially joint pain and stiffness. Additionally, the effectiveness of noninvasive neuromodulation (NESA) will be compared with transcutaneous electrical nerve stimulation (TENS), both in combination with therapeutic exercise. It is also expected to improve functionality, mental health, quality of life, and associated psychosocial factors in people over 60 years of age with knee osteoarthritis. Once the intervention is completed, a final evaluation will be conducted, and the comparative process will determine whether there are significant differences compared to the initial results.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
110
The study will include two treatment groups over an 8-week intervention. Group 1 will follow a therapeutic exercise program of 24 supervised sessions (three per week, 45-50 minutes each) combined with 24 sessions of non-invasive neuromodulation (NESA). Group 2 will perform the same therapeutic exercise program but combined with 24 sessions of transcutaneous electrical nerve stimulation (TENS), also delivered three times per week for 45 minutes. The exercise program will include strength, power, balance, and proprioception training, with loads individualized according to pain tolerance, physical condition, clinical phase, and symptoms, and progressed gradually by adjusting repetitions, external load, or range of motion. All participants will be assessed before and after the intervention period, with results recorded systematically.
ICOT rehabilitation centers
Las Palmas de Gran Canaria, Spain
RECRUITINGPain Score - Numeric Rating Scale for Pain (0-10)
Pain intensity will be assessed using the Numeric Rating Scale for Pain, which ranges from 0 to 10, where 0 indicates no pain and 10 represents the worst pain imaginable. A reduction of ≥2 points is considered clinically significant.
Time frame: Up to eight weeks
Western Ontario and McMaster Universities Osteoarthritis Index
Knee osteoarthritis symptoms will be assessed using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), which evaluates pain, stiffness, and physical function. Higher scores indicate worse symptoms.
Time frame: Up to eight weeks
Knee Range of Motion - Goniometer
Knee joint range of motion will be evaluated using a goniometer. Lower values indicate reduced mobility, commonly associated with disease severity.
Time frame: Up to eight weeks
Strength Tests - Hand-held Dynamometry
Isometric muscle strength of the quadriceps, hamstrings, and handgrip will be measured using a hand-held dynamometer, expressed in kilograms (kg) or newtons (N). Lower scores indicate muscle weakness, often linked to osteoarthritis progression.
Time frame: Up to eight weeks
Timed Up and Go (TUG) Performance
Functional mobility will be assessed using the Timed Up and Go test, measured in seconds (standing up, walking 3 m, turning, and sitting down). Values \>12 seconds indicate an increased risk of falls.
Time frame: Up to eight weeks
Short Physical Performance Battery - Global Score
Physical performance will be assessed through balance tests, gait speed, and sit-to-stand tasks. Scores ≤9 indicate functional limitation.
Time frame: Up to eight weeks
Tinetti Balance and Gait Score
Balance and gait will be evaluated using the Tinetti Assessment Tool, ranging from 0 to 28, where scores \<19 indicate a high risk of falls.
Time frame: Up to eight weeks
Pain Catastrophizing Scale.
Pain catastrophizing will be assessed with the Pain Catastrophizing Scale, ranging from 0 to 52. Scores ≥30 indicate clinically relevant catastrophizing.
Time frame: Up to eight weeks
Total TSK-11 Score - Tampa Scale for Kinesiophobia
Kinesiophobia will be measured using the 11-item Tampa Scale for Kinesiophobia, with scores ranging from 11 to 44. Scores ≥23 indicate high fear of movement.
Time frame: Up to eight weeks
Falls Efficacy Scale-International
Fear of falling will be assessed using the FES-I, ranging from 16 to 64. Scores \>23 indicate concern, and \>28 indicate high concern about falling.
Time frame: Up to eight weeks
Pittsburgh Sleep Quality Index
Sleep quality will be assessed using the Pittsburgh Sleep Quality Index, which ranges from 0 to 21, with scores \>5 indicating poor sleep quality.
Time frame: Up to eight weeks
Osteoarthritis Knee and Hip Quality of Life Questionnaire
Quality of life will be evaluated using the Osteoarthritis Knee and Hip Quality of Life Questionnaire, covering physical, mental, and social domains. Higher scores reflect greater impairment.
Time frame: Up to eight weeks
Hospital Anxiety and Depression Scale
Anxiety and depression will be evaluated using the Hospital Anxiety and Depression Scale, with each subscale ranging from 0 to 21. Scores ≥11 indicate clinically significant symptoms.
Time frame: Up to eight weeks
Heart Rate Variability Parameters
Autonomic regulation will be assessed through heart rate variability parameters (SDNN, RMSSD, LF/HF ratio) using ECG or a validated wearable device. Lower HRV indicates poorer autonomic regulation.
Time frame: Up to eight weeks
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