Effects of Including Interferential Current in a Therapeutic Exercise Program in Individuals With Knee Osteoarthritis

University of Nove de Julho

Status: Enrolling

Conditions: Osteoarthritis, Knee

Treatments: Other: Therapeutic Exercise; Device: placebo interferential current; Device: Interferential Current

Study type: Interventional

Funder types: Other

Identifiers

NCT06744036

7.267.733

Details and patient eligibility

About

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=42) and therapeutic exercises + IC (n=42) and therapeutic exercises + IC placebo. 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.

Enrollment: 126 estimated patients

Sex: All

Ages: 40 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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126 participants in 3 patient groups, including a placebo group

Therapeutic Exercise Group

Active Comparator group

Description:

The therapeutic exercise program includes a warm-up, resistance, neuromuscular, mobility, and balance exercises.

Treatment:

Other: Therapeutic Exercise

Therapeutic Exercises Group + Interferential Current

Experimental group

Description:

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 around the center of the knee. The parameters used were as follows: carrier current frequency of 4000 Hz; amplitude modulated frequency of 50 Hz; sweep frequency of 50 Hz; oscillation pattern of 1:1 second, and the amplitude of the current will be increased until the research participants report strong but comfortable and non-painful stimulation paresthesia. The IC will be applied for 30 minutes.

Treatment:

Device: Interferential Current

Other: Therapeutic Exercise

Therapeutic Exercises + placebo interferential current (ET + placebo IC) group

Placebo Comparator group

Description:

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 around the center of the knee.The device will only be turned on for the first minute.

Treatment:

Device: placebo interferential current

Other: Therapeutic Exercise