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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-75
SponsorUniversity of Nove de Julho

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Hip OA

Severe osteoporosis

Fibromyalgia

Clinical history of tumors or cancer

Trial design

Design model

Parallel

Treatments tested in this trial

  • Therapeutic Exercise

    Other intervention

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

  • 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.

  • 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

Treatment groups

138 Participants
are divided into 3 treatment groups
Group A: Therapeutic Exercise GroupActive comparator 1 intervention
Group B: Therapeutic Exercises Group + Interferential CurrentExperimental treatment 2 interventions
Group C: Therapeutic Exercises + placebo interferential current (ET + placebo IC) groupPlacebo comparator 2 interventions

Trial outcomes

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).

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

Secondary outcomes

1

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'.

Time frame
before the first treatment session, after 8 weeks of treatment and 4 weeks after the end of the last session
2

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).

Time frame
before the first treatment session, after 8 weeks of treatment and 4 weeks after the end of the last session
3

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.

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

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.

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

Other outcomes

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