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Clinical Trial NCT06744036 for Osteoarthritis, Knee is active, not recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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Effects of Including Interferential Current in a Therapeutic Exercise Program in Individuals With Knee Osteoarthritis 138 Randomized Exercise-Based
Clinical Trial NCT06744036 is an interventional study for Osteoarthritis, Knee that is active, not recruiting. It started on 20 January 2025 with plans to enroll 138 participants. Led by University of Nove de Julho, it is expected to complete by 28 May 2026. The latest data from ClinicalTrials.gov was last updated on 20 March 2026.
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...Show More
Detailed Description
The sample size calculation was revised to reflect a more appropriate and accurate outcome: The sample size was calculated based on the study's primary outcome, the Pain subscale of the KOOS. For the calculation, a clinically important difference between groups of 11.8 points was considered, a value derived from a systematic review specific to individuals with knee osteoarthritis undergoing non-surgical interventions...Show More
Official Title
Effects of Including Interferential Current in a Therapeutic Exercise Program in Individuals With Knee Osteoarthritis
Conditions
Osteoarthritis, KneeOther Study IDs
- 7.267.733
NCT ID Number
Start Date (Actual)
2025-01-20
Last Update Posted
2026-03-20
Completion Date (Estimated)
2026-05-28
Enrollment (Estimated)
138
Study Type
Interventional
PHASE
N/A
Status
Active, not recruiting
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Single
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
Active ComparatorTherapeutic Exercise Group The therapeutic exercise program includes a warm-up, resistance, neuromuscular, mobility, and balance exercises. | Therapeutic Exercise The therapeutic exercise program includes a warm-up, resistance, neuromuscular, mobility, and balance exercises. |
ExperimentalTherapeutic Exercises Group + Interferential Current The therapeutic exercise program includes a warm-up, resistance, neuromuscular, mobility, and balance exercises. However, the interferential current will be applied at the end of the therapeutic exercises. In this way, the IC will be used through a device (Endophasys® - NMS-0501, KLD Biosistemas® Equipamentos Eletrônicos Ltda). Four electrodes (8x5 cm), two upper and two lower (forming a square), will be positioned a...Show More | Therapeutic Exercise The therapeutic exercise program includes a warm-up, resistance, neuromuscular, mobility, and balance exercises. Interferential Current However, the interferential current will be applied at the end of the therapeutic exercises. In this way, the IC will be used through a device (Endophasys® - NMS-0501, KLD Biosistemas® Equipamentos Eletrônicos Ltda). Four electrodes (8x5 cm), two upper and two lower (forming a square), will be positioned around the center of the knee. The parameters used were as follows: carrier current frequency of 4000 Hz; amplitud...Show More |
Placebo ComparatorTherapeutic Exercises + placebo interferential current (ET + placebo IC) group The therapeutic exercise program includes a warm-up, resistance, neuromuscular, mobility, and balance exercises. However, the interferential current will be applied at the end of the therapeutic exercises. In this way, the IC will be used through a device (Endophasys® - NMS-0501, KLD Biosistemas® Equipamentos Eletrônicos Ltda). Four electrodes (8x5 cm), two upper and two lower (forming a square), will be positioned a...Show More | Therapeutic Exercise The therapeutic exercise program includes a warm-up, resistance, neuromuscular, mobility, and balance exercises. placebo interferential current However, the interferential current will be applied at the end of the therapeutic exercises. In this way, the IC will be used through a device (Endophasys® - NMS-0501, KLD Biosistemas® Equipamentos Eletrônicos Ltda). Four electrodes (8x5 cm), two upper and two lower (forming a square), will be positioned around the center of the knee. The parameters used were as follows: carrier current frequency of 4000 Hz; amplitud...Show More |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Reported pain | Knee Injury and Osteoarthritis Outcome Score (KOOS). It aims to evaluate the domains of pain, symptoms, activities of daily living, function related to recreation and sports, and quality of life related to the knee. Totaling 42 items, each item must be answered using a Likert scale that ranges from 0 (best score) to 4 (worst score), and the score for each subscale ranges from 0 (worst score) to 100 (best score). | before the first treatment session, after 8 weeks of treatment and 4 weeks after the end of the last session |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Numerical Pain Scale | The Numerical rating pain scale, a simple, easily administered scale evaluates the perceived intensity of pain, using an 11-point scale from 0, representing 'no pain', to 10, which is the 'worst possible pain'. | before the first treatment session, after 8 weeks of treatment and 4 weeks after the end of the last session |
Functional disability | Knee Injury and Osteoarthritis Outcome Score (KOOS). It aims to evaluate the domains of pain, symptoms, activities of daily living, function related to recreation and sports, and quality of life related to the knee. Totaling 42 items, each item must be answered using a Likert scale that ranges from 0 (best score) to 4 (worst score), and the score for each subscale ranges from 0 (worst score) to 100 (best score). | before the first treatment session, after 8 weeks of treatment and 4 weeks after the end of the last session |
Functional self-perception | Pain self-efficacy questionnaire, structured into 10 items where each item is evaluated by selecting a number on a 7-point numerical scale (scores from 0 to 6), where 0 means "not at all confident" and 6 means "completely confident". The items cover different functions, from work, social activities, domestic tasks and coping with pain without medication. A total score is calculated from the sum of the scores for each of the 10 items, producing a total score that ranges from 0 to 60. Higher scores reflect stronger self-efficacy beliefs. | before the first treatment session, after 8 weeks of treatment and 4 weeks after the end of the last session |
Functional capacity | Sit and stand test. The volunteer will sit down and stand up from a chair for 30 seconds. A researcher will time the total time it takes to complete this activity. | before the first treatment session, after 8 weeks of treatment and 4 weeks after the end of the last session |
Inability | Patient-specific functional scale. The participant will indicate three activities that he/she has difficulty performing. For each of these activities, the participant will indicate a score from 0 to 10. Higher scores indicate how well the participant can perform the activity. Lower scores indicate an inability to perform the activity. | before the first treatment session, after 8 weeks of treatment and 4 weeks after the end of the last session |
Maximum voluntary isometric contraction | manual dynamometer portable (Lafayette Manual Muscle System, Modelo 01165, Lafayette Instrument Company, Lafayette, IN). Four 5-second readings will be taken during maximal voluntary isometric contraction (MVIC) with a 30-second rest period between contractions. The first CIVM will familiarize the volunteer with carrying out the task. A new set of readings will be taken if a volunteer can perform three contractions with at least 10% variability. Strong and constant verbal stimuli will be used throughout the test. Always with the research participants' hands positioned crossed on the chest. Thus, bilateral assessments of the muscles, quadriceps, and gluteus medius will be carried out. The order of CIVM readings will be randomized to avoid collection bias. The research participant will remain in lateral decubitus with a pillow positioned between the legs, with the limb to be tested superiorly in a neutral position. | before the first treatment session, after 8 weeks of treatment and 4 weeks after the end of the last session |
Global Perception of Change scale | The perception of the global effect of the treatment by the research participant will be evaluated by the Global Perception of Change scale. The Global Perception of Change scale is a direct scale on the patient's self-perception when the intervention is performed. This scale consists of 11 points, ranging from -5 (worsening compared to the start of treatment), 0 (neutral) and +5 (improvement compared to the start of treatment), using the Portuguese version. | before the first treatment session, after 8 weeks of treatment and 4 weeks after the end of the last session |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
40 Years
Eligible Sexes
All
- 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
- 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
Study Responsible Party
Cid André Fidelis de Paula Gomes, Principal Investigator, Professor, University of Nove de Julho
No contact data.
1 Study Locations in 1 Countries
University of Nove de Julho, São Paulo, 01504-001, Brazil