Multimodal Treatment of Knee Osteoarthritis: Therapeutic Exercise and Noninvasive Neuromodulation (NESA) Versus Therapeutic Exercise and Transcutaneous Electrical Nerve Stimulation (TENS) in People Over 60 Years of Age.

NCT07258693 | Active Not Recruiting

• 1 other identifier: -UUJA
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Osteo Arthritis Knee

Outcome Measures

Primary Outcomes (14)

• Pain 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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  Up to eight weeks

Study Arms (2)

Exercise + NESA

EXPERIMENTAL

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.

Other: Therapeutic exercise and NESA VS. Therapeutic exercise and TENS

Exercise + TENS

EXPERIMENTAL

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.

Other: Therapeutic exercise and NESA VS. Therapeutic exercise and TENS

Interventions

Therapeutic exercise and NESA VS. Therapeutic exercise and TENS OTHER

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.

Exercise + NESA; Exercise + TENS

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Jaén: lead

Study Sites (1)

ICOT rehabilitation centers

Las Palmas de Gran Canaria, Spain

Location

MeSH Terms

Interventions

Exercise Therapy; Transcutaneous Electric Nerve Stimulation

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Electric Stimulation Therapy; Analgesia; Anesthesia and Analgesia

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: November 20, 2025
• First Posted: December 2, 2025
• Study Start: January 7, 2026
• Primary Completion: January 12, 2026
• Study Completion: April 7, 2026
• Last Updated: March 6, 2026

Record last verified: 2026-03

Locations

ES (1)