Knee OsteoarthritisNCT03588195
Educational Program for Knee Osteoarthritis
A study testing Educational Program and Transcutaneous Nerve Electro-Stimulation in people with Knee Osteoarthritis, run by Federal University of São Paulo.
Trial summary
Sixty patients with a diagnosis of knee osteoarthritis, aged between 40 and 80 years, of both genders were included. The patients were divided into: experimental group that carried out an educational program - 5 consecutive sessions held once a week, with a duration of 60 minutes each class and at the end of the last… Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Educational Program and Transcutaneous Nerve Electro-Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2016to 17 Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of knee Osteoarthritis by American College of Rheumatology criteria;
- Age between 40 and 80 years;
- Both genders;
- Numerical Pain Scale in the knee between 3 and 8 centimeters on a scale of 0 to 10 centimeters.
Who cannot join
- Systemic inflammatory diseases or any condition that prevents the practice of physical activity;
- Regular physical activity started or changed in the last twelve weeks;
- No ambulation;
- Joint injection in the knee in the previous twelve weeks;
- Previous knee surgery or surgery planned for the next twenty-four weeks;
- Physiotherapy in the last twelve weeks;
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- Other disease that affects the lower limbs;
- Open wounds at the electrode application site;
- Planned trip in the next twelve weeks.
About this study
Official title: Evaluation of the Effectiveness of an Educational Program in Patients With Osteoarthritis of the Knee: a Randomized Controlled Trial
Sixty patients with a diagnosis of knee osteoarthritis, aged between 40 and 80 years, of both genders were included. The patients were divided into: experimental group that carried out an educational program - 5 consecutive sessions held once a week, with a duration of 60 minutes each class and at the end of the last class, a booklet was delivered for each patient with all the contents of the classes and the Transcutaneous Nerve Electro-Stimulation device - being performed twice weekly, for 5 weeks for 40 minutes each session; and control group who only underwent treatment with the Transcutaneous Nerve Electro-Stimulation in the same parameters as experimental group. The evaluations were performed at the beginning of the treatment, 4 and 12 weeks after the beginning of the treatment using a numerical pain scale; WOMAC; IDATE and SF-36 questionnaires; and 6-minute walk test.
- Conditions
- Knee Osteoarthritis
- Being tested
- Educational Program, Transcutaneous Nerve Electro-Stimulation
- Keywords
- Education, Pain, Function, Quality of life
- Medical subject headings
- Osteoarthritis, Knee, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational ProgramOther
Educational program consist in 5 consecutive sessions held once a week, with a duration of 60 minutes each class and at the end of the last class, a booklet was delivered for each patient with all the contents of the classes. This group also received Transcutaneous Nerve Electro-Stimulation twice weekly, for 5 weeks for 40 minutes each session
Transcutaneous Nerve Electro-StimulationDevice
Transcutaneous Nerve Electro-Stimulation performed twice weekly, for 5 weeks for 40 minutes each session
| Study group | Role | What they receive |
|---|---|---|
| Education Group | Experimental | Not described Receives: Other: Educational Program; Device: Transcutaneous Nerve Electro-Stimulation |
| Control Group | Active comparator | Not described Receives: Device: Transcutaneous Nerve Electro-Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pain
Evaluated using a numeric pain scale
Measured: Baseline and after 4 and 12 weeks
Secondary outcomes (4)
Change in function
Evaluated using the Western Ontario and McMaster Universities Osteoarthritis Index
Measured: Baseline and after 4 and 12 weeks
Change in Anxiety
Evaluated using the Inventory Anxiety Trait Inventory - State
Measured: Baseline and after 4 and 12 weeks
Change in Generic Quality of life
Evaluated using the SF-36 questionnaire
Measured: Baseline and after 4 and 12 weeks
Change in Functional capacity
Evaluated with the six minute walk test
Measured: Baseline and after 4 and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2018
- Study start1 Feb 2016
- Primary completion24 Oct 2017
- Study completion17 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anamaria Jones, Federal University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03588195
- Sponsor's protocol ID
- CEP UNIFESP 458293
- Status last verified
- Jul 2018
- First submitted
- 4 Jul 2018
- Last updated
- 26 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effectiveness of an Educational Program in Patients With Osteoarthritis of the Knee: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03588195
- Acronym / sponsor ID
- CEP UNIFESP 458293
- Conditions
- Knee Osteoarthritis
- Keywords
- Education, Pain, Function, Quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Study start
- 1 Feb 2016 (actual)
- Primary completion
- 24 Oct 2017 (actual)
- Study completion
- 17 Jun 2018 (actual)
- First posted
- 17 Jul 2018 (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.
Sixty patients with a diagnosis of knee osteoarthritis, aged between 40 and 80 years, of both genders were included. The patients were divided into: experimental group that carried out an educational program - 5 consecutive sessions held once a week, with a duration of 60 minutes each class and at the end of the last class, a booklet was delivered for each patient with all the contents of the classes and the Transcutaneous Nerve Electro-Stimulation device - being performed twice weekly, for 5 weeks for 40 minutes each session; and control group who only underwent treatment with the Transcutaneous Nerve Electro-Stimulation in the same parameters as experimental group. The evaluations were performed at the beginning of the treatment, 4 and 12 weeks after the beginning of the treatment using a numerical pain scale; WOMAC; IDATE and SF-36 questionnaires; and 6-minute walk test.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Education Group | Experimental | Other: Educational Program, Device: Transcutaneous Nerve Electro-Stimulation |
| Control Group | Active comparator | Device: Transcutaneous Nerve Electro-Stimulation |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of knee Osteoarthritis by American College of Rheumatology criteria;
- Age between 40 and 80 years;
- Both genders;
- Numerical Pain Scale in the knee between 3 and 8 centimeters on a scale of 0 to 10 centimeters.
Key exclusion criteria (9 listed)
- Systemic inflammatory diseases or any condition that prevents the practice of physical activity;
- Regular physical activity started or changed in the last twelve weeks;
- No ambulation;
- Joint injection in the knee in the previous twelve weeks;
- Previous knee surgery or surgery planned for the next twenty-four weeks;
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 |
|---|---|---|
| Educational ProgramEducational program consist in 5 consecutive sessions held once a week, with a duration of 60 minutes each class and at the end of the last class, a booklet was delivered for each patient with all the contents of the classes. This group also received Transcutaneous Nerve Electro-Stimulation twice weekly, for 5 weeks for 40 minutes each session | Other | Education Group |
| Transcutaneous Nerve Electro-StimulationTranscutaneous Nerve Electro-Stimulation performed twice weekly, for 5 weeks for 40 minutes each session | Device | Control Group, Education Group |
Primary outcome
Change in Pain
Time frame: Baseline and after 4 and 12 weeks
Evaluated using a numeric pain scale
4 secondary outcomes
Change in function
Time frame: Baseline and after 4 and 12 weeks
Change in Anxiety
Time frame: Baseline and after 4 and 12 weeks
Change in Generic Quality of life
Time frame: Baseline and after 4 and 12 weeks
Change in Functional capacity
Time frame: Baseline and after 4 and 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2018.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Educational Program and Transcutaneous Nerve Electro-Stimulation in people with Knee Osteoarthritis, run by Federal University of São Paulo.
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 9 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: finished, as of the sponsor's last update on 26 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pain (time frame: Baseline and after 4 and 12 weeks). 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 26 Jul 2018.