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

NCT06744036 | Active Not Recruiting DMC

• 1 other identifier: 7.267.733
• Study Type: interventional
• Target: 138
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis, Knee

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (7)

• Numerical Pain Scale

  before the first treatment session, after 8 weeks of treatment and 4 weeks after the end of the last session

• Functional disability

  before the first treatment session, after 8 weeks of treatment and 4 weeks after the end of the last session

• Functional self-perception

  before the first treatment session, after 8 weeks of treatment and 4 weeks after the end of the last session

• Functional capacity

  before the first treatment session, after 8 weeks of treatment and 4 weeks after the end of the last session

• Inability

  before the first treatment session, after 8 weeks of treatment and 4 weeks after the end of the last session

Study Arms (3)

Therapeutic Exercise Group

ACTIVE COMPARATOR

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

Other: Therapeutic Exercise

Therapeutic Exercises Group + Interferential Current

EXPERIMENTAL

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.

Other: Therapeutic Exercise; Device: Interferential Current

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

PLACEBO COMPARATOR

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.

Other: Therapeutic Exercise; Device: placebo interferential current

Interventions

Therapeutic Exercise OTHER

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

Therapeutic Exercise Group; Therapeutic Exercises + placebo interferential current (ET + placebo IC) group; Therapeutic Exercises Group + Interferential Current

Interferential Current DEVICE

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 interferential current will be applied for 30 minutes.

Therapeutic Exercises Group + Interferential Current

placebo interferential current DEVICE

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 device will only be turned on in the first minute

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

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Nove de Julho: lead

Study Sites (1)

University of Nove de Julho

São Paulo, 01504-001, Brazil

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Exercise Therapy; Electric Stimulation Therapy

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The evaluator will only participate in the evaluation process.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 16, 2024
• First Posted: December 20, 2024
• Study Start: January 20, 2025
• Primary Completion: April 30, 2026
• Study Completion (Estimated): May 28, 2026
• Last Updated: March 20, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)