NCT06184451 Effects of TENS During the Performance of a Therapeutic Exercise Protocol in Individuals With Knee Osteoarthritis.
| NCT ID | NCT06184451 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Nove de Julho |
| Condition | Osteoarthritis, Knee |
| Study Type | INTERVENTIONAL |
| Enrollment | 90 participants |
| Start Date | 2024-03-01 |
| Primary Completion | 2026-01-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 90 participants in total. It began in 2024-03-01 with a primary completion date of 2026-01-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Research participants diagnosed with knee Osteoarthritis will be randomized through a draw using sealed opaque envelopes indicating two groups: 1. Therapeutic Exercises + Transcutaneous electrical nerve stimulation and 2. Therapeutic Exercises + placebo Transcutaneous electrical nerve stimulation. Therefore, individuals of both sexes, aged 40 years or over, with a clinical diagnosis of unilateral osteoarthritis of the knee, who present with knee pain for more than three months, morning stiffness for less than 30 minutes, crepitus, bone sensitivity and absence of palpable heat, and diagnosis established radiographically (determined by Kellgren and Lawrence grade 1 to 3 on scale 1 to 4). Exclusion criteria are bilateral knee Osteoarthritis, hip Osteoarthritis, severe osteoporosis, fibromyalgia, clinical history of tumors or cancer, active inflammatory joint diseases (rheumatoid arthritis, gout), undergoing any lower extremity joint replacement, neurological disorders (Parkinson's disease, stroke, multiple sclerosis, muscular dystrophies, motor neuron disease, Alzheimer's disease), infected wounds or osteomyelitis in the knee region, deep vein thrombosis or thrombophlebitis, sensory changes in the lower limbs, cognitive impairment, and cardiopulmonary disorders that may prevent or limit the execution of exercises, use of a walking assistance device, history of recent trauma to the knee, having undergone any form of treatment involving physiotherapy, intra-articular corticosteroids, anti-inflammatories or chondroprotective within the six months before the start of interventions.
Eligibility Criteria
Inclusion Criteria: * clinical diagnosis of unilateral osteoarthritis of the knee * presenting knee pain for more than three months * morning stiffness for less than 30 minutes * crepitus, bone tenderness, and absence of palpable heat. Exclusion Criteria: * Bilateral knee osteoarthritis, hip osteoarthritis * severe osteoporosis * fibromyalgia * medical history of tumors or cancer * active inflammatory joint diseases (rheumatoid arthritis, gout), * undergoing any lower extremity joint replacement * neurological diseases (Parkinson's disease, Accident Cerebral Vascular, Multiple Sclerosis, muscular dystrophies, motor neuron disease, Alzheimer's disease) * infected wounds or osteomyelitis in the knee region * deep vein thrombosis or thrombophlebitis * sensory changes in the lower limbs * cognitive and cardiopulmonary impairment that may prevent or limit performing the exercises * using a walking assistance device * having a history of recent trauma to the knee, * having undergone any form of treatment involving physiotherapy * intra-articular corticosteroids, anti-inflammatories, or chondroprotective in the six months before the start of the interventions.
Contact & Investigator
Cid Gomes, PhD
PRINCIPAL INVESTIGATOR
Study Principal Investigator
Frequently Asked Questions
Who can join the NCT06184451 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, up to 75 Years, studying Osteoarthritis, Knee. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06184451 currently recruiting?
Yes, NCT06184451 is actively recruiting participants. Contact the research team at cid.andre@gmail.com for enrollment information.
Where is the NCT06184451 trial being conducted?
This trial is being conducted at São Paulo, Brazil.
Who is sponsoring the NCT06184451 clinical trial?
NCT06184451 is sponsored by University of Nove de Julho. The principal investigator is Cid Gomes, PhD at Study Principal Investigator. The trial plans to enroll 90 participants.