Knee OsteoarthritisPhase 4NCT02443974
Bracing to Treat Knee Osteoarthritis in Elderly
A Phase 4 study testing Brace (Fisiotensor®) and Sleeve (Fisiotensor®) in people with Knee Osteoarthritis, run by Federal University of São Paulo at 1 site in Brazil.
Trial summary
Background: Osteoarthritis (OA) is highly prevalent in the elderly, with the knee being the most commonly affected joint in this population. Knee braces are often used to prevent common problems in knees during daily activities. The purpose of these devices is to decrease pain and improve functionality. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Brace (Fisiotensor®) and Sleeve (Fisiotensor®)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteBrazil
- Study dates
- Apr 2015to Mar 2016
- Phase
- Phase 4
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- pain in numerical pain scale between 3 and 7cm;
- Knee ligamentous instability
Who cannot join
- fibromyalgia and neurologic disease;
- knee or hip replacement
- surgery scheduled in the following 6 months
- start physical activity or received joint injection in the past three months
- need to use walking aids or brace in knee
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Knee Bracing in Elderly With Knee Osteoarthritis: a Randomized, Controlled Trial
Background: Osteoarthritis (OA) is highly prevalent in the elderly, with the knee being the most commonly affected joint in this population. Knee braces are often used to prevent common problems in knees during daily activities. The purpose of these devices is to decrease pain and improve functionality. In the literature some studies have tested the effectiveness of unloader brace for valgus or varus. However, the braces most used in the investigators' clinical setting and the less costly ones have not been described in quality studies in the literature. There are only few studies on this subject and they are methodologically inadequate. There are no studies that compared the effectiveness between the knee brace with metal hinges (no alignment) and knee brace without metal hinges. Objective: To evaluate the effectiveness of knee braces on pain, function and quality of life in the elderly with knee OA. Methods: Elderly with knee OA, both genders, with pain scale 3-7cm on a 10cm pain numeric scale were included. Of the 222 patients screened, 120 met the eligibility criteria and were randomized to the groups: without metal hinges, with metal hinges or control group. The groups without and with metal hinges received knee brace and were instructed to use it in daily activities, every day, during three months. Assessment for pain (NPS), function (WOMAC and Knee Lequesne) and quality of life (SF-36) were done at baseline and after 45, 90 and 180 days by a blinded assessor.
- Conditions
- Knee Osteoarthritis
- Being tested
- Brace (Fisiotensor®), Sleeve (Fisiotensor®)
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brace (Fisiotensor®)Device
Sleeve (Fisiotensor®)Device
| Study group | Role | What they receive |
|---|---|---|
| Knee brace group | Experimental | Patients received knee brace with hinges (Fisiotensor®) and were instructed to use it in daily activities, every day, during six months Receives: Device: Brace (Fisiotensor®) |
| Knee sleeve group | Experimental | Patients received knee sleeve without hinges (Fisiotensor®) and were instructed to use it in daily activities, every day, during six months Receives: Device: Sleeve (Fisiotensor®) |
| Control group | No intervention | Keep medication usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pain measured by a numeric pain scale
Measured: Baseline, after 45, 90 and 180 days
Secondary outcomes (2)
Change in function measured by Lequesne and WOMAC questionnaires
Measured: Baseline, after 45, 90 and 180 days
Change in quality of life measured by SF-36 questionnaire
Measured: Baseline, after 45, 90 and 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2015 (estimated)
- Study startApr 2015
- Primary completionNov 2015
- Study completionMar 2016
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christine Brumini, Federal University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02443974
- Sponsor's protocol ID
- CEP 1248/09
- Status last verified
- Jun 2016
- First submitted
- 8 Apr 2015
- Last updated
- 1 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Knee Bracing in Elderly With Knee Osteoarthritis: a Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT02443974
- Acronym / sponsor ID
- CEP 1248/09
- Conditions
- Knee Osteoarthritis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- Nov 2015 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 14 May 2015 (estimated)
- 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.
Background: Osteoarthritis (OA) is highly prevalent in the elderly, with the knee being the most commonly affected joint in this population. Knee braces are often used to prevent common problems in knees during daily activities. The purpose of these devices is to decrease pain and improve functionality. In the literature some studies have tested the effectiveness of unloader brace for valgus or varus. However, the braces most used in the investigators' clinical setting and the less costly ones have not been described in quality studies in the literature. There are only few studies on this subject and they are methodologically inadequate. There are no studies that compared the effectiveness between the knee brace with metal hinges (no alignment) and knee brace without metal hinges. Objective: To evaluate the effectiveness of knee braces on pain, function and quality of life in the elderly with knee OA. Methods: Elderly with knee OA, both genders, with pain scale 3-7cm on a 10cm pain numeric scale were included. Of the 222 patients screened, 120 met the eligibility criteria and were randomized to the groups: without metal hinges, with metal hinges or control group. The groups without and with metal hinges received knee brace and were instructed to use it in daily activities, every day, during three months. Assessment for pain (NPS), function (WOMAC and Knee Lequesne) and quality of life (SF-36) were done at baseline and after 45, 90 and 180 days by a blinded assessor.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Knee brace group | Experimental | Device: Brace (Fisiotensor®)Patients received knee brace with hinges (Fisiotensor®) and were instructed to use it in daily activities, every day, during six months |
| Knee sleeve group | Experimental | Device: Sleeve (Fisiotensor®)Patients received knee sleeve without hinges (Fisiotensor®) and were instructed to use it in daily activities, every day, during six months |
| Control group | No intervention | –Keep medication usual |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- pain in numerical pain scale between 3 and 7cm;
- Knee ligamentous instability
Key exclusion criteria (5 listed)
- fibromyalgia and neurologic disease;
- knee or hip replacement
- surgery scheduled in the following 6 months
- start physical activity or received joint injection in the past three months
- need to use walking aids or brace in knee
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 |
|---|---|---|
| Brace (Fisiotensor®) | Device | Knee brace group |
| Sleeve (Fisiotensor®) | Device | Knee sleeve group |
Primary outcome
Change in pain measured by a numeric pain scale
Time frame: Baseline, after 45, 90 and 180 days
2 secondary outcomes
Change in function measured by Lequesne and WOMAC questionnaires
Time frame: Baseline, after 45, 90 and 180 days
Change in quality of life measured by SF-36 questionnaire
Time frame: Baseline, after 45, 90 and 180 days
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 1 Jul 2016.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Brace (Fisiotensor®) and Sleeve (Fisiotensor®) in people with Knee Osteoarthritis, run by Federal University of São Paulo 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 2 inclusion and 5 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 1 Jul 2016. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 measured by a numeric pain scale (time frame: Baseline, after 45, 90 and 180 days). 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 1 Jul 2016.