Knee OsteoarthritisNCT02335034
Project Arthritis Recovering Quality of Life by Means Education II (PARQVE II)
A study testing Study Group Educational courses, DVD, print material of lectures in people with Knee Osteoarthritis and Osteoarthritis, run by University of Sao Paulo General Hospital at 2 sites in Brazil.
Trial summary
OBJECTIVE: To evaluate the improvement of patients with gonarthritis exposed to a multidisciplinary care program with and without associated classroom educational program. METHODS: 152 patients (men and women) aged 40 or older with arthritis stages I to III of Kelgren and Lawrence. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Knee Osteoarthritis, Osteoarthritis
- What is being tested?
- Study Group Educational courses, DVD, print material of lectures
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 222 participants
- Where
- 2 sitesBrazil
- Study dates
- Dec 2014to Mar 2019
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women diagnosed with primary osteoarthritis of the knee,
- Classified as stages I to III of Kelgreen and Lawrence (KL), ie any degree of gonarthritis without obliteration of the joint space.
- With indication for clinical treatment of OA.
Who cannot join
- Patients with cognitive, psychiatric and neurological disorders or whose symptoms during the evaluation are related or significantly interfere in the functions of attention, memory, logical thinking, understanding and interaction with the group in order to hinder the assimilation of the given guidelines.
- Missing classroom interventions
Trial locations and contacts
2 sites in 1 country.
Brazil2 sites
Instituto de Ortopedia e Traumatologia do Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo
São Paulo, 05403-010
Instituto de Ortopedia e Traumatologia - HCFMUSP
São Paulo, 05411-001
About this study
Official title: Project Osteoarthritis: Recovering Quality of Life by Means Education II (PARQVE II) - A Prospective Randomized Study Comparing the Multidisciplinary Care Associated With Education to Multidisciplinary Treatment Without Education.
OBJECTIVE: To evaluate the improvement of patients with gonarthritis exposed to a multidisciplinary care program with and without associated classroom educational program. METHODS: 152 patients (men and women) aged 40 or older with arthritis stages I to III of Kelgren and Lawrence. Have been treated with drugs, orthotics and referred to physical rehabilitation (physiotherapy and/or physical activity). Patients will be randomized into 2 groups of 76 and will go through pre-assessment with multidisciplinary team: Psychologist - assess cognitive ability; level of anxiety, and depression. Nutritionist - anthropometric parameters and diet quality. Social Worker - Level of education, religion, autonomy and mobility capacity to the hospital. Physiotherapist - range of motion, pain, function and quality of life. Occupational Therapy - range of motion and strength. Physical Educator - level of physical activity and functional capacity. Orthopaedic - additional examinations, disease classification, orthotics, report to Social Security and Traffic Department, evaluation questionnaires (SF 36, VAS, WOMAC, LEQUESNE), referral to physical therapy, physical activity and inform consent. A group will submitted to two interventions, with an interval of two months between each intervention. The control group will only make evaluations / consultations with all professional teams without classes for 2 years, then will attend the courses and will be followed by two more years. Interventions will be lectures and practices with the seven professional teams, covering the topic arthritis (orthopedic team), what is disease, being ill, and the role of the patient in the treatment (psychology) to obtain behavioral change. Lectures and practices with physical therapy and occupational therapy to show the importance of exercise in relieving symptoms (physical therapy), the importance of rest and proper ergonomics at home and at work (occupational therapy). The nutritionist shows proper alimentation. Lecture and practice with physical educator (showing the difference between the laber work and regular physical activity as well as the importance of strength exercises, resistance and stretching) and theoretical class with the social service by calling attention to the importance of leisure. After two months, the second intervention is made in order to verify the acquired concepts. Six months, 1, 2, 3 and 4 years after the first evaluation, the groups will be called to new multi evaluation.
- Conditions
- Knee Osteoarthritis, Osteoarthritis
- Being tested
- Study Group Educational courses, DVD, print material of lectures, Control Group only make evaluations / consultations with all professional teams
- Keywords
- Osteoarthritis, Knee, Education, Quality of life, Treatment outcome, Musculoskeletal pain
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis, Musculoskeletal Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Study Group Educational courses, DVD, print material of lecturesBehavioural
2 Educational courses (two months apart). Receive DVD and printed material of the lectures.
Control Group only make evaluations / consultations with all professional teamsBehavioural
Evaluations and consultations with all professional teams without classes for 2 years.
At two years: two days of lectures two months apart with DVD and printed material of the lectures. Will be followed by two more years.
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | Intervention: study group will attend two days of classes (two months apart) with the seven professional teams, covering what is the disease arthritis, its causes and treatment options; what is disease, being ill, and the role of the patient in the treatment to obtain behavioral change; the importance of exercise in relieving symptoms, the importance of rest and proper ergonomics at home and at work; proper alimentation; the difference between labor work and regular physical activity as well as the importance of strength resistance and stretching exercises; and the importance of leisure. The second intervention verifies the acquired concepts. Receives: Behavioral: Study Group Educational courses, DVD, print material of lectures |
| Control Group | Experimental | The control group will only make evaluations / consultations with all professional teams without classes for 2 years, then will attend the courses and will be followed by two more years. Receives: Behavioral: Control Group only make evaluations / consultations with all professional teams |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in pain of patients with knee osteoarthritis by multi-professional care and education. (Visual Analogue Scale (VAS) and Womac)
Visual Analogue Scale (VAS) and Womac pain at 6 months, 1, 2, 3 and 4 years
Measured: 5 years
Improvement in function of patients with knee osteoarthritis by multi-professional care and education. (testing and HAQ (Health Assessment Questionnaire )and DASH (Disabilities of the Arm, Shoulder And Hand questionnaires)
Lequesne, Womac, TUG (Timed Up and Go), FTSST ( Five Time Sit to Stand Test), Sit to Stand 30 Second Test, Palmar pressure force, Digital pinch strength, Range of motion (ROM) of the upper limbs (UL), Application of HAQ (Health Assessment Questionnaire )and DASH (Disabilities of the Arm, Shoulder And Hand questionnaires) at 6 months, 1, 2, 3 and 4 years
Measured: 5 years
Improvement in percentage of body fat of patients with knee osteoarthritis by multi-professional care and education. (skinfolds measurements)
Nine skinfolds measurements at 6, 12, 24, 36 and 48 months
Measured: 5 years
quality of life of patients with knee osteoarthritis by multi-professional care and education..
SF-36 at 6, 12, 24, 36 and 48 months
Measured: 5 years
Secondary outcomes (2)
Evaluate increase physical activity of patients with knee osteoarthritis by multi-professional care and education. (Minutes per week of light, moderate or intense physical acitivity)
Minutes per week of light, moderate or intense physical acitivity
Measured: 5 years
Evaluate changes in BMI of patients with knee osteoarthritis by multi-professional care and education.
By measuring height and weight at 6, 12, 24, 36 and 48 months.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2015 (estimated)
- Study startDec 2014
- Primary completionMar 2019
- Study completionMar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by University of Sao Paulo General HospitalThe sponsor's other registered studies.
- 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 222 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- TRB Chemedica
- Responsible party
- Sponsor
- Investigators
- Marcia U Rezende, MD. PhD, Principal investigator, Department of Orthopedics and Traumatology - Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02335034
- Sponsor's protocol ID
- 12671/14
- Status last verified
- Jan 2019
- First submitted
- 22 Dec 2014
- Last updated
- 9 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Lane NE, Brandt K, Hawker G, Peeva E, Schreyer E, Tsuji W, Hochberg MC. OARSI-FDA initiative: defining the disease state of osteoarthritis. Osteoarthritis Cartilage. 2011 May;19(5):478-82. doi: 10.1016/j.joca.2010.09.013. Epub 2011 Mar 23.
PubMed 21396464Woolf AD, Pfleger B. Burden of major musculoskeletal conditions. Bull World Health Organ. 2003;81(9):646-56. Epub 2003 Nov 14.
PubMed 14710506WHO Scientific Group on the Burden of Musculoskeletal Conditions at the Start of the New Millennium. The burden of musculoskeletal conditions at the start of the new millennium. World Health Organ Tech Rep Ser. 2003;919:i-x, 1-218, back cover.
PubMed 14679827Kwok WY, Vliet Vlieland TP, Rosendaal FR, Huizinga TW, Kloppenburg M. Limitations in daily activities are the major determinant of reduced health-related quality of life in patients with hand osteoarthritis. Ann Rheum Dis. 2011 Feb;70(2):334-6. doi: 10.1136/ard.2010.133603. Epub 2010 Nov 15.
PubMed 21081529Dawson J, Linsell L, Zondervan K, Rose P, Randall T, Carr A, Fitzpatrick R. Epidemiology of hip and knee pain and its impact on overall health status in older adults. Rheumatology (Oxford). 2004 Apr;43(4):497-504. doi: 10.1093/rheumatology/keh086. Epub 2004 Feb 3.
PubMed 14762225Dixon T, Shaw M, Ebrahim S, Dieppe P. Trends in hip and knee joint replacement: socioeconomic inequalities and projections of need. Ann Rheum Dis. 2004 Jul;63(7):825-30. doi: 10.1136/ard.2003.012724.
PubMed 15194578Mahomed NN, Barrett J, Katz JN, Baron JA, Wright J, Losina E. Epidemiology of total knee replacement in the United States Medicare population. J Bone Joint Surg Am. 2005 Jun;87(6):1222-8. doi: 10.2106/JBJS.D.02546.
PubMed 15930530Blagojevic M, Jinks C, Jeffery A, Jordan KP. Risk factors for onset of osteoarthritis of the knee in older adults: a systematic review and meta-analysis. Osteoarthritis Cartilage. 2010 Jan;18(1):24-33. doi: 10.1016/j.joca.2009.08.010. Epub 2009 Sep 2.
PubMed 19751691Jorgensen KT, Pedersen BV, Nielsen NM, Hansen AV, Jacobsen S, Frisch M. Socio-demographic factors, reproductive history and risk of osteoarthritis in a cohort of 4.6 million Danish women and men. Osteoarthritis Cartilage. 2011 Oct;19(10):1176-82. doi: 10.1016/j.joca.2011.07.009. Epub 2011 Jul 27.
PubMed 21835256Zhang W, Nuki G, Moskowitz RW, Abramson S, Altman RD, Arden NK, Bierma-Zeinstra S, Brandt KD, Croft P, Doherty M, Dougados M, Hochberg M, Hunter DJ, Kwoh K, Lohmander LS, Tugwell P. OARSI recommendations for the management of hip and knee osteoarthritis: part III: Changes in evidence following systematic cumulative update of research published through January 2009. Osteoarthritis Cartilage. 2010 Apr;18(4):476-99. doi: 10.1016/j.joca.2010.01.013. Epub 2010 Feb 11.
PubMed 20170770Rodrigues da Silva JM, de Rezende MU, Spada TC, da Silva Francisco L, Sabine de Farias FE, Clemente da Silva CA, Cernigoy CHA, Greve JMD, Ciolac EG. Educational program promoting regular physical exercise improves functional capacity and daily living physical activity in subjects with knee osteoarthritis. BMC Musculoskelet Disord. 2017 Dec 27;18(1):546. doi: 10.1186/s12891-017-1912-7.
PubMed 29282054
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Project Osteoarthritis: Recovering Quality of Life by Means Education II (PARQVE II) - A Prospective Randomized Study Comparing the Multidisciplinary Care Associated With Education to Multidisciplinary Treatment Without Education.
- ClinicalTrials.gov ID
- NCT02335034
- Acronym / sponsor ID
- 12671/14
- Conditions
- Knee Osteoarthritis, Osteoarthritis
- Keywords
- Osteoarthritis, Knee, Education, Quality of life, Treatment outcome, Musculoskeletal pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 222 participants (actual)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Collaborators
- TRB Chemedica
- Study start
- Dec 2014 (actual)
- Primary completion
- Mar 2019 (actual)
- Study completion
- Mar 2019 (actual)
- First posted
- 9 Jan 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.
OBJECTIVE: To evaluate the improvement of patients with gonarthritis exposed to a multidisciplinary care program with and without associated classroom educational program. METHODS: 152 patients (men and women) aged 40 or older with arthritis stages I to III of Kelgren and Lawrence. Have been treated with drugs, orthotics and referred to physical rehabilitation (physiotherapy and/or physical activity). Patients will be randomized into 2 groups of 76 and will go through pre-assessment with multidisciplinary team: Psychologist - assess cognitive ability; level of anxiety, and depression. Nutritionist - anthropometric parameters and diet quality. Social Worker - Level of education, religion, autonomy and mobility capacity to the hospital. Physiotherapist - range of motion, pain, function and quality of life. Occupational Therapy - range of motion and strength. Physical Educator - level of physical activity and functional capacity. Orthopaedic - additional examinations, disease classification, orthotics, report to Social Security and Traffic Department, evaluation questionnaires (SF 36, VAS, WOMAC, LEQUESNE), referral to physical therapy, physical activity and inform consent. A group will submitted to two interventions, with an interval of two months between each intervention. The control group will only make evaluations / consultations with all professional teams without classes for 2 years, then will attend the courses and will be followed by two more years. Interventions will be lectures and practices with the seven professional teams, covering the topic arthritis (orthopedic team), what is disease, being ill, and the role of the patient in the treatment (psychology) to obtain behavioral change. Lectures and practices with physical therapy and occupational therapy to show the importance of exercise in relieving symptoms (physical therapy), the importance of rest and proper ergonomics at home and at work (occupational therapy). The nutritionist shows proper alimentation. Lecture and practice with physical educator (showing the difference between the laber work and regular physical activity as well as the importance of strength exercises, resistance and stretching) and theoretical class with the social service by calling attention to the importance of leisure. After two months, the second intervention is made in order to verify the acquired concepts. Six months, 1, 2, 3 and 4 years after the first evaluation, the groups will be called to new multi evaluation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Behavioral: Study Group Educational courses, DVD, print material of lecturesIntervention: study group will attend two days of classes (two months apart) with the seven professional teams, covering what is the disease arthritis, its causes and treatment options; what is disease, being ill, and the role of the patient in the treatment to obtain behavioral change; the importance of exercise in relieving symptoms, the importance of rest and proper ergonomics at home and at work; proper alimentation; the difference between labor work and regular physical activity as well as the importance of strength resistance and stretching exercises; and the importance of leisure. The second intervention verifies the acquired concepts. |
| Control Group | Experimental | Behavioral: Control Group only make evaluations / consultations with all professional teamsThe control group will only make evaluations / consultations with all professional teams without classes for 2 years, then will attend the courses and will be followed by two more years. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Men and women diagnosed with primary osteoarthritis of the knee,
- Classified as stages I to III of Kelgreen and Lawrence (KL), ie any degree of gonarthritis without obliteration of the joint space.
- With indication for clinical treatment of OA.
Key exclusion criteria (2 listed)
- Patients with cognitive, psychiatric and neurological disorders or whose symptoms during the evaluation are related or significantly interfere in the functions of attention, memory, logical thinking, understanding and interaction with the group in order to hinder the assimilation of the given guidelines.
- Missing classroom interventions
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 |
|---|---|---|
| Study Group Educational courses, DVD, print material of lectures2 Educational courses (two months apart). Receive DVD and printed material of the lectures. | Behavioural | Study group |
| Control Group only make evaluations / consultations with all professional teamsEvaluations and consultations with all professional teams without classes for 2 years. At two years: two days of lectures two months apart with DVD and printed material of the lectures. Will be followed by two more years. | Behavioural | Control Group |
Primary outcome
Improvement in pain of patients with knee osteoarthritis by multi-professional care and education. (Visual Analogue Scale (VAS) and Womac)
Time frame: 5 years
Visual Analogue Scale (VAS) and Womac pain at 6 months, 1, 2, 3 and 4 years
Improvement in function of patients with knee osteoarthritis by multi-professional care and education. (testing and HAQ (Health Assessment Questionnaire )and DASH (Disabilities of the Arm, Shoulder And Hand questionnaires)
Time frame: 5 years
Lequesne, Womac, TUG (Timed Up and Go), FTSST ( Five Time Sit to Stand Test), Sit to Stand 30 Second Test, Palmar pressure force, Digital pinch strength, Range of motion (ROM) of the upper limbs (UL), Application of HAQ (Health Assessment Questionnaire )and DASH (Disabilities of the Arm, Shoulder And Hand questionnaires) at 6 months, 1, 2, 3 and 4 years
Improvement in percentage of body fat of patients with knee osteoarthritis by multi-professional care and education. (skinfolds measurements)
Time frame: 5 years
Nine skinfolds measurements at 6, 12, 24, 36 and 48 months
quality of life of patients with knee osteoarthritis by multi-professional care and education..
Time frame: 5 years
SF-36 at 6, 12, 24, 36 and 48 months
2 secondary outcomes
Evaluate increase physical activity of patients with knee osteoarthritis by multi-professional care and education. (Minutes per week of light, moderate or intense physical acitivity)
Time frame: 5 years
Evaluate changes in BMI of patients with knee osteoarthritis by multi-professional care and education.
Time frame: 5 years
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 9 Jun 2020.
- Background: PubMed 21396464Lane NE, Brandt K, Hawker G, Peeva E, Schreyer E, Tsuji W, Hochberg MC. OARSI-FDA initiative: defining the disease state of osteoarthritis. Osteoarthritis Cartilage. 2011 May;19(5):478-82. doi: 10.1016/j.joca.2010.09.013. Epub 2011 Mar 23.
- Background: PubMed 14710506Woolf AD, Pfleger B. Burden of major musculoskeletal conditions. Bull World Health Organ. 2003;81(9):646-56. Epub 2003 Nov 14.
- Background: PubMed 14679827WHO Scientific Group on the Burden of Musculoskeletal Conditions at the Start of the New Millennium. The burden of musculoskeletal conditions at the start of the new millennium. World Health Organ Tech Rep Ser. 2003;919:i-x, 1-218, back cover.
- Background: PubMed 21081529Kwok WY, Vliet Vlieland TP, Rosendaal FR, Huizinga TW, Kloppenburg M. Limitations in daily activities are the major determinant of reduced health-related quality of life in patients with hand osteoarthritis. Ann Rheum Dis. 2011 Feb;70(2):334-6. doi: 10.1136/ard.2010.133603. Epub 2010 Nov 15.
- Background: PubMed 14762225Dawson J, Linsell L, Zondervan K, Rose P, Randall T, Carr A, Fitzpatrick R. Epidemiology of hip and knee pain and its impact on overall health status in older adults. Rheumatology (Oxford). 2004 Apr;43(4):497-504. doi: 10.1093/rheumatology/keh086. Epub 2004 Feb 3.
- Background: PubMed 15194578Dixon T, Shaw M, Ebrahim S, Dieppe P. Trends in hip and knee joint replacement: socioeconomic inequalities and projections of need. Ann Rheum Dis. 2004 Jul;63(7):825-30. doi: 10.1136/ard.2003.012724.
- Background: PubMed 15930530Mahomed NN, Barrett J, Katz JN, Baron JA, Wright J, Losina E. Epidemiology of total knee replacement in the United States Medicare population. J Bone Joint Surg Am. 2005 Jun;87(6):1222-8. doi: 10.2106/JBJS.D.02546.
- Background: PubMed 19751691Blagojevic M, Jinks C, Jeffery A, Jordan KP. Risk factors for onset of osteoarthritis of the knee in older adults: a systematic review and meta-analysis. Osteoarthritis Cartilage. 2010 Jan;18(1):24-33. doi: 10.1016/j.joca.2009.08.010. Epub 2009 Sep 2.
- Background: PubMed 21835256Jorgensen KT, Pedersen BV, Nielsen NM, Hansen AV, Jacobsen S, Frisch M. Socio-demographic factors, reproductive history and risk of osteoarthritis in a cohort of 4.6 million Danish women and men. Osteoarthritis Cartilage. 2011 Oct;19(10):1176-82. doi: 10.1016/j.joca.2011.07.009. Epub 2011 Jul 27.
- Background: PubMed 20170770Zhang W, Nuki G, Moskowitz RW, Abramson S, Altman RD, Arden NK, Bierma-Zeinstra S, Brandt KD, Croft P, Doherty M, Dougados M, Hochberg M, Hunter DJ, Kwoh K, Lohmander LS, Tugwell P. OARSI recommendations for the management of hip and knee osteoarthritis: part III: Changes in evidence following systematic cumulative update of research published through January 2009. Osteoarthritis Cartilage. 2010 Apr;18(4):476-99. doi: 10.1016/j.joca.2010.01.013. Epub 2010 Feb 11.
- Derived from this study: PubMed 29282054Rodrigues da Silva JM, de Rezende MU, Spada TC, da Silva Francisco L, Sabine de Farias FE, Clemente da Silva CA, Cernigoy CHA, Greve JMD, Ciolac EG. Educational program promoting regular physical exercise improves functional capacity and daily living physical activity in subjects with knee osteoarthritis. BMC Musculoskelet Disord. 2017 Dec 27;18(1):546. doi: 10.1186/s12891-017-1912-7.
- Instituto Brasileiro de Geografia e Estatística. Dados preliminares do Censo 2010 já revelam mudanças na pirâmide etária brasileiraLink provided by the sponsor.
- POF 2008-2009: desnutrição cai e peso das crianças brasileiras ultrapassa padrão internacionalLink provided by the sponsor.
- PARQVE-Project Arthritis Recovering Quality of Life by Means of Education Short-term Outcome in a Randomized Clinical TrialLink provided by the sponsor.
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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.
Marcia U Rezende, MD. PhD principal investigator
Department of Orthopedics and Traumatology - Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Study Group Educational courses, DVD, print material of lectures in people with Knee Osteoarthritis and Osteoarthritis, run by University of Sao Paulo General Hospital at 2 sites 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 3 inclusion and 2 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 9 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
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?
Improvement in pain of patients with knee osteoarthritis by multi-professional care and education. (Visual Analogue Scale (VAS) and Womac) (time frame: 5 years). The study lists 4 primary outcomes in all. 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 NCT02335034, which also lists 11 linked publications.
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 9 Jun 2020.