Osteoarthritis, KneeNCT06184451
Effects of TENS During the Performance of a Therapeutic Exercise Protocol in Individuals With Knee Osteoarthritis.
A study testing Therapeutic exercise and Transcutaneous electrical nerve stimulation in people with Osteoarthritis, Knee, run by University of Nove de Julho at 1 site in Brazil.
Trial summary
Research participants diagnosed with knee Osteoarthritis will be randomized through a draw using sealed opaque envelopes indicating two groups: 1. Therapeutic Exercises + Transcutaneous electrical nerve stimulation and 2. Therapeutic Exercises + placebo Transcutaneous electrical nerve stimulation. 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 Transcutaneous electrical nerve stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Mar 2024to 1 Jan 2027
- 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
- clinical diagnosis of unilateral osteoarthritis of the knee
- presenting knee pain for more than three months
- morning stiffness for less than 30 minutes
- crepitus, bone tenderness, and absence of palpable heat.
Who cannot join
- Bilateral knee osteoarthritis, hip osteoarthritis
- severe osteoporosis
- fibromyalgia
- medical history of tumors or cancer
- active inflammatory joint diseases (rheumatoid arthritis, gout),
- undergoing any lower extremity joint replacement
Show all 15Show fewer
- 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.
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
- Recruiting
Nove de Julho University
São Paulo, 01504-001
Cid Gomes
Cid Gomes, Phd
About this study
Official title: Effects of TENS During the Performance of a Therapeutic Exercise Protocol in Individuals With Knee Osteoarthritis: Controlled, Randomized, and Blinded Clinical Trial
Research participants diagnosed with knee Osteoarthritis will be randomized through a draw using sealed opaque envelopes indicating two groups: 1. Therapeutic Exercises + Transcutaneous electrical nerve stimulation and 2. Therapeutic Exercises + placebo Transcutaneous electrical nerve stimulation.
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.
- Conditions
- Osteoarthritis, Knee
- Being tested
- Therapeutic exercise, Transcutaneous electrical nerve stimulation, Placebo transcutaneous electrical nerve stimulation
- 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. 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 stimulationDevice
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 stimulationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Therapeutic exercise and Transcutaneous electrical nerve stimulation | Experimental | 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. Receives: Other: Therapeutic exercise; Device: Transcutaneous electrical nerve stimulation |
| Therapeutic exercise and Placebo Transcutaneous electrical nerve stimulation | Placebo comparator | 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. Receives: Other: Therapeutic exercise; Device: Placebo transcutaneous electrical nerve stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: Change from Baseline, after 5 weeks of intervention and 4 weeks after the end of the intervention.
Secondary outcomes (7)
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: Change from Baseline, after 5 weeks of intervention and 4 weeks after the end of the intervention.
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: Change from Baseline, after 5 weeks of intervention and 4 weeks after the end of the intervention.
Lower limb functionality
30 second sit and stand test. From a sitting position with feet flat on the floor and shoulder-width apart, arms crossed across the chest, the individual assessed must stand, with hips and knees fully extended. Then, he must sit down, with his lower part completely touching the seat, repeating these movements continuously for 30 seconds. The chair must be placed against the wall. The total number of complete cycles will be counted (standing up and sitting down represents one cycle).
Measured: Change from Baseline, after 5 weeks of intervention and 4 weeks after the end of the intervention.
Self-perceived functionality
Patient Specific Functional Scale. An easy-to-apply self-report instrument, validated for measuring disability related to specific tasks identified by the individual. The scale is made up of 11 (eleven) numbers, graduated from 0 (zero) to 10 (ten), where 0 (zero) represents inability to perform the activity and ten (ten) the ability to perform the activity at the level prior to the current condition.
Measured: Change from Baseline, after 5 weeks of intervention and 4 weeks after the end of the intervention.
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: Change from Baseline, after 5 weeks of intervention and 4 weeks after the end of the intervention.
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: Change from Baseline, after 5 weeks of intervention and 4 weeks after the end of the intervention.
Functionality
The World Health Organization Disability Assessment Schedule 2.0 short version (12 items) is a generic self-report assessment instrument developed by the World Health Organization (WHO) to assess functionality and disability during the last 30 days.For each item, a Likert-type scale will be used to define the severity of the limitation, with a score of 0 (Zero) denoting "no limitation" and 4 (four) denoting "extreme limitation or inability to function." The total score is the sum of all 12 items, where a score of 48 points represents the worst possible restriction.
Measured: Change from Baseline, after 5 weeks of intervention and 4 weeks after the end of the intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2023
- Study start1 Mar 2024
- Primary completion1 Jan 2026 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Model description
- Controlled clinical trial, two arms randomized and blind.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nove de Julho
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cid André Fidelis de Paula Gomes, University of Nove de Julho
- Investigators
- Cid Gomes, PhD, Principal investigator, Study Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06184451
- Sponsor's protocol ID
- 75610223.5.0000.5511
- Status last verified
- Oct 2024
- First submitted
- 14 Dec 2023
- Last updated
- 8 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Make data available remotely in digital cloud storage.
Publications
Dos Santos PG, Liebano RE, Verengue BR, da Silva ACB, Miura BG, Girasol CE, Dibai-Filho AV, Fidelis-de-Paula-Gomes CA. Effects of Using High-Frequency TENS During an Exercise Therapy Program in Knee Osteoarthritis: A Randomized Sham-Controlled Trial. Physiother Res Int. 2026 Oct;31(4):e70351. doi: 10.1002/pri.70351.
PubMed 42775508
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of TENS During the Performance of a Therapeutic Exercise Protocol in Individuals With Knee Osteoarthritis: Controlled, Randomized, and Blinded Clinical Trial
- ClinicalTrials.gov ID
- NCT06184451
- Acronym / sponsor ID
- 75610223.5.0000.5511
- Conditions
- Osteoarthritis, Knee
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- University of Nove de JulhoUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 28 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Research participants diagnosed with knee Osteoarthritis will be randomized through a draw using sealed opaque envelopes indicating two groups: 1. Therapeutic Exercises + Transcutaneous electrical nerve stimulation and 2. Therapeutic Exercises + placebo Transcutaneous electrical nerve stimulation.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Controlled clinical trial, two arms randomized and blind.
| Arm | Type | Receives |
|---|---|---|
| Therapeutic exercise and Transcutaneous electrical nerve stimulation | Experimental | Other: Therapeutic exercise, Device: Transcutaneous electrical nerve stimulationThe 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 and Placebo Transcutaneous electrical nerve stimulation | Placebo comparator | Other: Therapeutic exercise, Device: Placebo transcutaneous electrical nerve stimulationParticipants 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. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- clinical diagnosis of unilateral osteoarthritis of the knee
- presenting knee pain for more than three months
- morning stiffness for less than 30 minutes
- crepitus, bone tenderness, and absence of palpable heat.
Key exclusion criteria (15 listed)
- Bilateral knee osteoarthritis, hip osteoarthritis
- severe osteoporosis
- fibromyalgia
- medical history of tumors or cancer
- active inflammatory joint diseases (rheumatoid arthritis, gout),
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Therapeutic exerciseThe 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. | Other | Therapeutic exercise and Placebo Transcutaneous electrical nerve stimulation, Therapeutic exercise and Transcutaneous electrical nerve stimulation |
| Transcutaneous electrical nerve stimulationTENS 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. | Device | Therapeutic exercise and Transcutaneous electrical nerve stimulation |
| Placebo transcutaneous electrical nerve stimulationThe 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. | Device | Therapeutic exercise and Placebo Transcutaneous electrical nerve stimulation |
Primary outcome
Functional disability
Time frame: Change from Baseline, after 5 weeks of intervention and 4 weeks after the end of the intervention.
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).
7 secondary outcomes
Numerical Pain Scale
Time frame: Change from Baseline, after 5 weeks of intervention and 4 weeks after the end of the intervention.
Functional self-perception
Time frame: Change from Baseline, after 5 weeks of intervention and 4 weeks after the end of the intervention.
Lower limb functionality
Time frame: Change from Baseline, after 5 weeks of intervention and 4 weeks after the end of the intervention.
Self-perceived functionality
Time frame: Change from Baseline, after 5 weeks of intervention and 4 weeks after the end of the intervention.
Maximum voluntary isometric contraction
Time frame: Change from Baseline, after 5 weeks of intervention and 4 weeks after the end of the intervention.
Global Perception of Change scale
Time frame: Change from Baseline, after 5 weeks of intervention and 4 weeks after the end of the intervention.
Functionality
Time frame: Change from Baseline, after 5 weeks of intervention and 4 weeks after the end of the intervention.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2024.
- Derived from this study: PubMed 42775508Dos Santos PG, Liebano RE, Verengue BR, da Silva ACB, Miura BG, Girasol CE, Dibai-Filho AV, Fidelis-de-Paula-Gomes CA. Effects of Using High-Frequency TENS During an Exercise Therapy Program in Knee Osteoarthritis: A Randomized Sham-Controlled Trial. Physiother Res Int. 2026 Oct;31(4):e70351. doi: 10.1002/pri.70351.
- Individual participant dataSharing planned: Undecided. Make data available remotely in digital cloud storage.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Cid Gomes, PhD principal investigator
Study Principal Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Therapeutic exercise and Transcutaneous electrical nerve stimulation 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 4 inclusion and 15 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 8 Oct 2024. 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?
Contact Cid Gomes, PhD (+5511970941936, cid.andre@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional disability (time frame: Change from Baseline, after 5 weeks of intervention and 4 weeks after the end of the intervention.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06184451, which also lists 1 linked publication.
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 8 Oct 2024.