Knee OsteoarthritisPhase 4NCT02835521
Influence of Perception of Patients Suffering of Knee Osteoarthritis Regarding Effectiveness of Intra-articular Injection
A Phase 4 study testing Reception and Joint injection with triamcinolone hexacetonide in people with Knee Osteoarthritis, run by Federal University of São Paulo.
Trial summary
Introduction; reception must be understood as the offered attention within the relationship between a healthcare worker and the patient, including attitudes of inclusion, hearing, valorization of complains and identification of needs, being these individual collective. Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Reception and Joint injection with triamcinolone hexacetonide
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Aug 2016to Jul 2017
- 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 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- knee osteoarthritis according to american college of rheumatology criteria
- no previous experience of joint injection
- stable use of drugs for osteoarthritis treatment for at least 3 months
- stable dose of corticosteroids, non hormonal anti-inflammatory and analgesics in the previous month
- pain on knee between 3 and 7 in the visual analogue scale
- signe the informed consent term
- radiologic classification between 1-3 (kellgren and Lawrence classification)
Who cannot join
- joint disease of different etiology
- coagulation alteration
- non treated fibromyalgia
- litigation
- diabetes mellitus and systemic arterial hypertension out of control
- allergy of lidocaine or triamcinolone hexacetonide
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Influence of Perception of Patients Suffering of Osteoarthritis of Knee Over the Effectiveness and Tolerance in Intra-articular Injection of Corticoids: a Prospective, Controlled and Randomized Study
Introduction; reception must be understood as the offered attention within the relationship between a healthcare worker and the patient, including attitudes of inclusion, hearing, valorization of complains and identification of needs, being these individual collective. As a part of this process, communication is a primary and indispensable toll through which the healthcare team and the patient interchange information.
Objective: to evaluate the influence of perception of patients suffering of knee osteoarthritis over fear, catastrophizing of pain and effectiveness, related to intra-articular injection od corticosteroids.
Material and method: it will be performed a prospective, controlled and randomized study eith a blind evaluator on patients with symptomatic knee osteoarthritis submitted to joint injection. A hundred patients suffering of symptomatic knee osteoarthritis coming from the outpatient area of Rheumatology Division of Federal University of Sao Paulo (UNIFESP) will be evaluated, 50 belonging to the intervention group (reception) and 50 to a control group.
- Conditions
- Knee Osteoarthritis
- Being tested
- Reception, Joint injection with triamcinolone hexacetonide
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ReceptionProcedure or surgery
Joint injection with triamcinolone hexacetonideDrug
joint injection with corticosteroids
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Patients will receive the reception treatment before the joint injection Receives: Procedure: Reception; Drug: Joint injection with triamcinolone hexacetonide |
| Control Group | Active comparator | patient will receive a joint injection Receives: Drug: Joint injection with triamcinolone hexacetonide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change on pain
Pain will be evaluated with an visual analogue scale
Measured: baseline, after 1, 4 and 12 weeks
Secondary outcomes (3)
Change on functional capacity
functional capacity will be evaluated with Health assesment questionary (HAQ)
Measured: baseline, after 1, 4 and 12 weeks
Change on Catastrophizing
Catastrophizing will be evaluated with an Catastrophizing test
Measured: baseline, after 1, 4 and 12 weeks
Change on functional capacity
functional capacity will be evaluated with the time to up and go test
Measured: baseline, after 1, 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 posted18 Jul 2016 (estimated)
- Study startAug 2016
- Primary completionFeb 2017 (estimated)
- Study completionJul 2017 (estimated)
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
- Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sandra Regina Toffolo, Federal University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02835521
- Sponsor's protocol ID
- CEP UNIFESP - 849746
- Status last verified
- Jul 2016
- First submitted
- 11 Jul 2016
- Last updated
- 18 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 18 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Perception of Patients Suffering of Osteoarthritis of Knee Over the Effectiveness and Tolerance in Intra-articular Injection of Corticoids: a Prospective, Controlled and Randomized Study
- ClinicalTrials.gov ID
- NCT02835521
- Acronym / sponsor ID
- CEP UNIFESP - 849746
- Conditions
- Knee Osteoarthritis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Study start
- Aug 2016
- Primary completion
- Feb 2017 (estimated)
- Study completion
- Jul 2017 (estimated)
- First posted
- 18 Jul 2016 (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.
Introduction; reception must be understood as the offered attention within the relationship between a healthcare worker and the patient, including attitudes of inclusion, hearing, valorization of complains and identification of needs, being these individual collective. As a part of this process, communication is a primary and indispensable toll through which the healthcare team and the patient interchange information.
Objective: to evaluate the influence of perception of patients suffering of knee osteoarthritis over fear, catastrophizing of pain and effectiveness, related to intra-articular injection od corticosteroids.
Material and method: it will be performed a prospective, controlled and randomized study eith a blind evaluator on patients with symptomatic knee osteoarthritis submitted to joint injection. A hundred patients suffering of symptomatic knee osteoarthritis coming from the outpatient area of Rheumatology Division of Federal University of Sao Paulo (UNIFESP) will be evaluated, 50 belonging to the intervention group (reception) and 50 to a control group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Procedure: Reception, Drug: Joint injection with triamcinolone hexacetonidePatients will receive the reception treatment before the joint injection |
| Control Group | Active comparator | Drug: Joint injection with triamcinolone hexacetonidepatient will receive a joint injection |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- knee osteoarthritis according to american college of rheumatology criteria
- no previous experience of joint injection
- stable use of drugs for osteoarthritis treatment for at least 3 months
- stable dose of corticosteroids, non hormonal anti-inflammatory and analgesics in the previous month
- pain on knee between 3 and 7 in the visual analogue scale
Key exclusion criteria (6 listed)
- joint disease of different etiology
- coagulation alteration
- non treated fibromyalgia
- litigation
- diabetes mellitus and systemic arterial hypertension out of control
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 |
|---|---|---|
| Reception | Procedure or surgery | Intervention Group |
| Joint injection with triamcinolone hexacetonidejoint injection with corticosteroids | Drug | Control Group, Intervention Group |
Primary outcome
Change on pain
Time frame: baseline, after 1, 4 and 12 weeks
Pain will be evaluated with an visual analogue scale
3 secondary outcomes
Change on functional capacity
Time frame: baseline, after 1, 4 and 12 weeks
Change on Catastrophizing
Time frame: baseline, after 1, 4 and 12 weeks
Change on functional capacity
Time frame: baseline, after 1, 4 and 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Reception and Joint injection with triamcinolone hexacetonide 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 7 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 18 Jul 2016. 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.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sandra R Toffolo, Msc nurse (551155764239, s-regina-toffolo@bol.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change on pain (time frame: baseline, after 1, 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 18 Jul 2016.