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Osteoarthritis, KneeNCT06744036

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

A study testing Therapeutic Exercise and Interferential Current in people with Osteoarthritis, Knee, run by University of Nove de Julho at 1 site in Brazil.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 40 to 75 years
Conditions the study is for
Osteoarthritis, Knee
What is being tested?
Therapeutic Exercise and Interferential Current
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
138 participants
Where
1 siteBrazil
Study dates
20 Jan 2025to 28 Jul 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 21Show fewer
  • 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 locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Brazil1 site, 1 recruiting
  • University of Nove de Julho

    São Paulo, 01504-001

    Cid A Gomes, Master of Science, +5511970941936, cid.andre@gmail.com

    Cid A Gomes, master of science

    Recruiting

Other trials in Brazil

About this study

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.

Read the 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, rounded to approximately 12 points for clinical interpretation purposes. A standard deviation of 18.2 points was adopted, based on a study involving individuals with mild to moderate knee osteoarthritis under non-surgical management. Considering a statistical power of 80% and α = 0.05, the required sample size of 38 per group was estimated. After adding 20% to account for possible losses, the final sample size was set at 46 participants per group.

Silva MDC, Perriman DM, Fearon AM, Couldrick JM, Scarvell JM. Minimal important change and difference for knee osteoarthritis outcome measurement tools after non-surgical interventions: a systematic review. BMJOpen. 2023;13(5):e063026. Published 2023 May 18. doi:10.1136/bmjopen-2022-063026

Being tested
Therapeutic Exercise, Interferential Current, placebo interferential current
Medical subject headings
Osteoarthritis, Knee

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Therapeutic ExerciseOther

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

  • Interferential CurrentDevice

    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 currentDevice

    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

Study groups in NCT06744036
Study groupRoleWhat they receive
Therapeutic Exercise GroupActive comparatorThe therapeutic exercise program includes a warm-up, resistance, neuromuscular, mobility, and balance exercises.
Receives: Other: Therapeutic Exercise
Therapeutic Exercises Group + Interferential CurrentExperimentalThe 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.
Receives: Other: Therapeutic Exercise; Device: Interferential Current
Therapeutic Exercises + placebo interferential current (ET + placebo IC) groupPlacebo comparatorThe 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.
Receives: Other: Therapeutic Exercise; Device: placebo interferential current

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

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

Secondary outcomes (7)
  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'.

    Measured: 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).

    Measured: 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.

    Measured: 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.

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

  5. 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.

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

  6. 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.

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

  7. 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Dec 2024
  2. Study start20 Jan 2025
  3. Primary completion30 Jun 2026 (estimated)
  4. Study completion28 Jul 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
138 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06744036
Sponsor's protocol ID
7.267.733
Status last verified
May 2026
First submitted
16 Dec 2024
Last updated
22 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Therapeutic Exercise and Interferential Current in people with Osteoarthritis, Knee, run by University of Nove de Julho at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Reported pain (time frame: before the first treatment session, after 8 weeks of treatment and 4 weeks after the end of the last session). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.

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