NCT06744036 Effects of Including Interferential Current in a Therapeutic Exercise Program in Individuals With Knee Osteoarthritis
| NCT ID | NCT06744036 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Nove de Julho |
| Condition | Osteoarthritis, Knee |
| Study Type | INTERVENTIONAL |
| Enrollment | 138 participants |
| Start Date | 2025-01-20 |
| Primary Completion | 2026-06-30 |
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 138 participants in total. It began in 2025-01-20 with a primary completion date of 2026-06-30.
⚠ 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
The first-line treatment for knee osteoarthritis (KOA) in terms of pain and functionality is physical exercise. The use of interferential current (IC) associated with other resources may be beneficial in reducing pain intensity and improving functionality. However, the effects of its simultaneous use with therapeutic exercise have not yet been fully established. The aim of this project will be to evaluate the effects of including IC in a therapeutic exercise program in relation to pain intensity, functionality, self-efficacy, maximum voluntary contraction and overall perceived effect in individuals with KOA. Therefore, research participants of both sexes, between 40 and 75 years old, with a clinical diagnosis of unilateral KOA, who have knee pain for more than 3 months, with a minimum score of 3 points on the numerical pain scale, morning stiffness for less than 30 minutes, crepitation, bone sensitivity, and absence of palpable heat will be recruited. The research participants will be randomized into three groups: therapeutic exercises (n=46) and therapeutic exercises + IC (n=46) and therapeutic exercises + IC placebo (n=46). Eight consecutive weeks of treatment will be carried out. The research participants will be evaluated before the intervention, after the end of the intervention of eight consecutive weeks of intervention and after four weeks at the end of the last week of intervention, through the instruments: numeric pain scale (NPS), Knee Injury and Osteoarthritis Outcome Score (KOOS), patient-specific functional scale (EFEP), Pain self-efficacy questionnaire (PSEQ), maximum voluntary isometric contraction (MVIC), 30-second sit-to-stand test (TSL30s), global perception scale (EPG). For data analysis, a normality test will be used to verify the distribution of the data and a statistical test appropriate for the appropriate intra and inter-group comparisons, thus considering two factors in the comparisons, time and group. A significance level of 5% will be adopted.
Eligibility Criteria
Inclusion Criteria: * both sexes * between 40 years old and 75 years old * with a clinical diagnosis of unilateral KOA * Who has had knee pain for more than 3 months * With a minimum score of 3 points on the numerical pain scale * Morning stiffness for less than 30 minutes * Crepitus * Bone tenderness and absence of palpable heat Exclusion Criteria: * Hip OA * Severe osteoporosis * Fibromyalgia * Clinical history of tumors or cancer * Active inflammatory joint diseases (rheumatoid arthritis, gout) * Undergoing any joint replacement in the lower extremity * Neurological diseases (Parkinson's disease, stroke * Multiple sclerosis * muscular dystrophies * Diseases involving motor neurons * Alzheimer's disease * Infected wounds or osteomyelitis in the knee region * Deep vein thrombosis or thrombophlebitis * Sensory alteration in the lower limbs * Cognitive and cardiopulmonary impairment that may prevent or limit the execution of exercises * Use of a walking assistance device * History of recent knee trauma * Having undergone any form of treatment involving physical therapy * intra-articular corticosteroids * anti-inflammatory drugs * opioid medication or chondroprotective in the six months before the start of the interventions
Frequently Asked Questions
Who can join the NCT06744036 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 NCT06744036 currently recruiting?
Yes, NCT06744036 is actively recruiting participants. Visit ClinicalTrials.gov or contact University of Nove de Julho to inquire about joining.
Where is the NCT06744036 trial being conducted?
This trial is being conducted at São Paulo, Brazil.
Who is sponsoring the NCT06744036 clinical trial?
NCT06744036 is sponsored by University of Nove de Julho. The trial plans to enroll 138 participants.