Multimodal Treatment of Knee Osteoarthritis: Comparison of the Combination of Therapeutic Exercise and Noninvasive Neuromodulation (NESA) Versus Therapeutic Exercise and Transcutaneous Electrical Nerve Stimulation (TENS) on Pain, Function, and Mental Health in People Over 60 Years of Age.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Pain Score - Numeric Rating Scale for Pain (0-10)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals over 60 years of age.
- •Diagnosis of knee osteoarthritis in at least one knee according to the clinical criteria of the American College of Rheumatology.
- •Ability to walk independently without the need for assistive devices.
- •No medical contraindications to physical exercise or the application of noninvasive neuromodulation (NESA).
- •Ability to understand and sign the informed consent form to participate in the study.
排除标准
- •Present medical contraindications to physical exercise or the application of noninvasive neuromodulation (NSA) (pacemaker, epilepsy, internal bleeding, acute febrile processes, acute thrombophlebitis, and/or phobia of electricity).
- •Present active oncological diseases or systemic autoimmune diseases.
- •Present severe psychiatric or neurological disorders that limit understanding and collaboration in treatment.
- •History of any surgery or fracture of the affected lower limb in the last 3 months.
- •Presence of severe gait or balance difficulties that impede the performance of the proposed exercises.
- •Simultaneous participation in other clinical trials.
研究组 & 干预措施
Exercise + NESA
A treatment group will be enrolled, following an initial assessment and with their consent, in a therapeutic exercise program combined with noninvasive neuromodulation (NESA). The intervention will last 8 weeks. The therapeutic exercise program will consist of 24 sessions, delivered three times a week with supervision, lasting 45-50 minutes per session. In addition, 24 noninvasive neuromodulation (NESA) sessions, each lasting 45 minutes, will be delivered three times a week over the course of the 8 weeks. The main exercise program will include strength, power, balance, and proprioception exercises. The loads will be individualized for each patient, adapting to their accepted pain threshold, physical characteristics, clinical stage, and symptoms. Progression criteria will be established to achieve progressive overload, modifying variables such as repetitions, external load, and range of motion.
干预措施: Therapeutic exercise and NESA VS. Therapeutic exercise and TENS (Other)
Exercise + TENS
A treatment group will receive the same therapeutic exercise program as the experimental group, along with transcutaneous electrical nerve stimulation (TENS). The intervention will last 8 weeks. The therapeutic exercise program will consist of 24 sessions, delivered three times a week with supervision, lasting 45-50 minutes per session. Additionally, 24 sessions of transcutaneous electrical nerve stimulation (TENS) will be delivered three times a week, lasting 45 minutes, distributed over the 8 weeks. The main exercise program will include strength, power, balance, and proprioception exercises. The loads will be individualized for each patient, adapting to their accepted pain threshold, physical characteristics, clinical stage, and symptoms. Progression criteria will be established to achieve progressive overload, modifying variables such as repetitions, external load, and range of motion.
干预措施: Therapeutic exercise and NESA VS. Therapeutic exercise and TENS (Other)
结局指标
主要结局
Pain Score - Numeric Rating Scale for Pain (0-10)
时间窗: Up to eight weeks
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.
Timed Up and Go (TUG) Performance
时间窗: Up to eight weeks
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.
Pain Catastrophizing Scale.
时间窗: Up to eight weeks
Pain catastrophizing will be assessed with the Pain Catastrophizing Scale, ranging from 0 to 52. Scores ≥30 indicate clinically relevant catastrophizing.
Total TSK-11 Score - Tampa Scale for Kinesiophobia
时间窗: Up to eight weeks
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.
Hospital Anxiety and Depression Scale
时间窗: Up to eight weeks
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.
Heart Rate Variability Parameters
时间窗: Up to eight weeks
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.
Strength Tests - Hand-held Dynamometry
时间窗: Up to eight weeks
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.
Western Ontario and McMaster Universities Osteoarthritis Index
时间窗: Up to eight weeks
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.
Knee Range of Motion - Goniometer
时间窗: Up to eight weeks
Knee joint range of motion will be evaluated using a goniometer. Lower values indicate reduced mobility, commonly associated with disease severity.
Falls Efficacy Scale-International
时间窗: Up to eight weeks
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.
Pittsburgh Sleep Quality Index
时间窗: Up to eight weeks
Sleep quality will be assessed using the Pittsburgh Sleep Quality Index, which ranges from 0 to 21, with scores \>5 indicating poor sleep quality.
Osteoarthritis Knee and Hip Quality of Life Questionnaire
时间窗: Up to eight weeks
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.
Short Physical Performance Battery - Global Score
时间窗: Up to eight weeks
Physical performance will be assessed through balance tests, gait speed, and sit-to-stand tasks. Scores ≤9 indicate functional limitation.
Tinetti Balance and Gait Score
时间窗: Up to eight weeks
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.
次要结局
未报告次要终点
研究者
Agustín Aibar Almazán
Principal investigator
University of Jaén