Effects of TENS During the Performance of a Therapeutic Exercise Protocol in Individuals With Knee Osteoarthritis.
NCT ID: NCT06184451
Last Updated: 2024-10-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
90 participants
INTERVENTIONAL
2024-03-01
2027-01-01
Brief Summary
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Therefore, individuals of both sexes, aged 40 years or over, with a clinical diagnosis of unilateral osteoarthritis of the knee, who present with knee pain for more than three months, morning stiffness for less than 30 minutes, crepitus, bone sensitivity and absence of palpable heat, and diagnosis established radiographically (determined by Kellgren and Lawrence grade 1 to 3 on scale 1 to 4).
Exclusion criteria are bilateral knee Osteoarthritis, hip Osteoarthritis, severe osteoporosis, fibromyalgia, clinical history of tumors or cancer, active inflammatory joint diseases (rheumatoid arthritis, gout), undergoing any lower extremity joint replacement, neurological disorders (Parkinson's disease, stroke, multiple sclerosis, muscular dystrophies, motor neuron disease, Alzheimer's disease), infected wounds or osteomyelitis in the knee region, deep vein thrombosis or thrombophlebitis, sensory changes in the lower limbs, cognitive impairment, and cardiopulmonary disorders that may prevent or limit the execution of exercises, use of a walking assistance device, history of recent trauma to the knee, having undergone any form of treatment involving physiotherapy, intra-articular corticosteroids, anti-inflammatories or chondroprotective within the six months before the start of interventions.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Therapeutic exercise and Transcutaneous electrical nerve stimulation
The therapeutic exercise program includes a warm-up, resistance, neuromuscular, mobility, and balance exercises. Therapeutic exercises will be performed in up to three sets of 8-12 repetitions or 30-60 seconds each, with rest intervals of 90 seconds between sets. Therapeutic exercises will be performed in up to three sets of 8-12 repetitions or 30-60 seconds each, with rest intervals of 90 seconds between sets. TENS will be applied with a portable device during the therapeutic exercise program. The equipment has a two-phase and pulsed symmetric quadratic waveform. 5x5cm adhesive electrodes will be applied to the lateral and medial edges and superior and inferior to the patella, in a crossed manner, surrounding the region.
Therapeutic exercise
The therapeutic exercise program includes a warm-up, resistance, neuromuscular, mobility, and balance exercises. Therapeutic exercises will be performed in up to three sets of 8-12 repetitions or 30-60 seconds each, with rest intervals of 90 seconds between sets.
Transcutaneous electrical nerve stimulation
TENS will be applied with a portable device, Neurodyn Portable System from Ibramed, while carrying out the entire therapeutic exercise program. The equipment has a two-phase and pulsed symmetric quadratic waveform. 5x5cm adhesive electrodes will be applied to the lateral and medial edges and superior and inferior to the patella, in a crossed manner, surrounding the region.
The parameters established for the protocol of this study are based on a survey already carried out, with continuous pulse mode, frequency of 150Hz, duration of 150us, and amplitude varying from 1-60mA or more as long as tolerated by the study participant, without causing pain. The application time will be proportional to the time of the exercise session, approximately 60 minutes. The researcher will evaluate the need to adjust the current intensity through the pulse amplitude regularly so that the stimulus does not accommodate.
Therapeutic exercise and Placebo Transcutaneous electrical nerve stimulation
Participants in the control group will perform the same therapeutic exercise protocol previously reported in the experimental group, associated with placebo TENS. To do this, the device will only be turned on during the first minute of therapeutic exercises. The same TENS parameters as the experimental group will be applied for this.
Therapeutic exercise
The therapeutic exercise program includes a warm-up, resistance, neuromuscular, mobility, and balance exercises. Therapeutic exercises will be performed in up to three sets of 8-12 repetitions or 30-60 seconds each, with rest intervals of 90 seconds between sets.
Placebo transcutaneous electrical nerve stimulation
The equipment has a two-phase and pulsed symmetric quadratic waveform. 5x5cm adhesive electrodes will be applied to the lateral and medial edges and superior and inferior to the patella, in a crossed manner, surrounding the region.
The parameters established for the protocol of this study are based on a survey already carried out, with continuous pulse mode, frequency of 150Hz, duration of 150us, and amplitude varying from 1-60mA or more as long as tolerated by the study participant, without causing pain. To do this, the device will only be turned on during the first minute of therapeutic exercises. The same TENS parameters as the experimental group will be applied for this.
Interventions
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Therapeutic exercise
The therapeutic exercise program includes a warm-up, resistance, neuromuscular, mobility, and balance exercises. Therapeutic exercises will be performed in up to three sets of 8-12 repetitions or 30-60 seconds each, with rest intervals of 90 seconds between sets.
Transcutaneous electrical nerve stimulation
TENS will be applied with a portable device, Neurodyn Portable System from Ibramed, while carrying out the entire therapeutic exercise program. The equipment has a two-phase and pulsed symmetric quadratic waveform. 5x5cm adhesive electrodes will be applied to the lateral and medial edges and superior and inferior to the patella, in a crossed manner, surrounding the region.
The parameters established for the protocol of this study are based on a survey already carried out, with continuous pulse mode, frequency of 150Hz, duration of 150us, and amplitude varying from 1-60mA or more as long as tolerated by the study participant, without causing pain. The application time will be proportional to the time of the exercise session, approximately 60 minutes. The researcher will evaluate the need to adjust the current intensity through the pulse amplitude regularly so that the stimulus does not accommodate.
Placebo transcutaneous electrical nerve stimulation
The equipment has a two-phase and pulsed symmetric quadratic waveform. 5x5cm adhesive electrodes will be applied to the lateral and medial edges and superior and inferior to the patella, in a crossed manner, surrounding the region.
The parameters established for the protocol of this study are based on a survey already carried out, with continuous pulse mode, frequency of 150Hz, duration of 150us, and amplitude varying from 1-60mA or more as long as tolerated by the study participant, without causing pain. To do this, the device will only be turned on during the first minute of therapeutic exercises. The same TENS parameters as the experimental group will be applied for this.
Eligibility Criteria
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Inclusion Criteria
* presenting knee pain for more than three months
* morning stiffness for less than 30 minutes
* crepitus, bone tenderness, and absence of palpable heat.
Exclusion Criteria
* severe osteoporosis
* fibromyalgia
* medical history of tumors or cancer
* active inflammatory joint diseases (rheumatoid arthritis, gout),
* undergoing any lower extremity joint replacement
* neurological diseases (Parkinson's disease, Accident Cerebral Vascular, Multiple Sclerosis, muscular dystrophies, motor neuron disease, Alzheimer's disease)
* infected wounds or osteomyelitis in the knee region
* deep vein thrombosis or thrombophlebitis
* sensory changes in the lower limbs
* cognitive and cardiopulmonary impairment that may prevent or limit performing the exercises
* using a walking assistance device
* having a history of recent trauma to the knee,
* having undergone any form of treatment involving physiotherapy
* intra-articular corticosteroids, anti-inflammatories, or chondroprotective in the six months before the start of the interventions.
40 Years
75 Years
ALL
No
Sponsors
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University of Nove de Julho
OTHER
Responsible Party
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Cid André Fidelis de Paula Gomes
Principal Investigator
Principal Investigators
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Cid Gomes, PhD
Role: PRINCIPAL_INVESTIGATOR
Study Principal Investigator
Locations
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Nove de Julho University
São Paulo, , Brazil
Countries
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Central Contacts
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Facility Contacts
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Cid Gomes
Role: primary
Other Identifiers
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75610223.5.0000.5511
Identifier Type: -
Identifier Source: org_study_id
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