OsteoarthritisNCT01031576
Postural Analysis in Patients With Knee Osteoarthritis
An observational study of Osteoarthritis, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
Osteoarthritis is the result of the degeneration of the cartilage to articulate, being currently considered as having an multifactorial cause.The knees are one of the affected joints more due to overload that constitutes the main activator or determinative mechanism for the development of the illness. Read more about this study
- Who is it for?
- Ages 60 to 80 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis
- How many people
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- Feb 2006to Jun 2009
- Phase
- Observational
- 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 to 80 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: 15 with diagnosis of OA of knees unilaterally and 15 healthful citizens, both the groups will be of the feminine sex with age between 65 to 75 years
Who may be able to join
- Clinical diagnosis of Osteoarthritis Disease
Who cannot join
- Others Disease orthopedics
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Postural Analysis and Eletromiographic Activity in Patients With Knee Osteoarthritis
Osteoarthritis is the result of the degeneration of the cartilage to articulate, being currently considered as having an multifactorial cause.The knees are one of the affected joints more due to overload that constitutes the main activator or determinative mechanism for the development of the illness. Beyond pain it has important reduction of the amplitude of movement and the muscular force that causes functional limitation and posture's alterations intervening with the activities of daily life. Therefore, the main objective of this study will be to characterize the posture's alterations and the electromiographic activity in patients with osteoarthritis of knees. For this study 30 citizens will be evaluated, 15 with diagnosis of OA of knees unilaterally and 15 healthful citizens, both the groups will be of the feminine sex with age between 60 to 80 years. The selected patients will answer a questionnaire of personal dates and will have an evaluation fiche, in which will be written down: age, index of corporal mass (IMC), index of Lesquene, index WOMAC (Western Ontario and Mac Master), personal and familiar date of the diagnosis, antecedents, instituted treatments, date of the last x-ray, radiological classification of the osteoarthritis according to Scale of Kellgren, electromiographics date and seeming of the postural evaluation. For the electromiographic evaluation the activity of the muscles vastus lateralis and medial oblique in the isometric contraction maximum volunteer (ICMV) and in the march will be analyzed. And for the postural evaluation will be made three photographs in the sights previous frontal and sagittal right and left, being that, for the analysis of the posturais alterations the program will be used SAPO.
Read the detailed description
Osteoarthritis is the result of the degeneration of the cartilage to articulate, being currently considered as having an multifactorial cause. Of the histological point of view it is characterized for alterations of the loss of the natural viscoelasticity, giving to origin the foci of "softening" in the cartilaginous surface that if gets depressed becoming discontinues for the appearance of "fibrillation zones" provoking reaction of the subcondral bone that if condemns in the pressure areas (sclerosis) and proliferates together to the edges of the joint (osteophytic). It is that affect millions of people annually and one of the main and a common condition causes pain functional incapacity generating enormous economic load for the community. The knees are one of the affected joints more due to overload that constitutes the main activator or determinative mechanism for the development of the illness. Beyond pain it has important reduction of the amplitude of movement and the muscular force that causes functional limitation and posture's alterations intervening with the activities of daily life. Therefore, the main objective of this study will be to characterize the posture's alterations and the electromiographic activity in patients with osteoarthritis of knees. For this study 60 citizens will be evaluated, 30 with diagnosis of OA of knees unilaterally and 30 healthful citizens, both the groups will be of the feminine sex with age between 65 to 75 years. The selected patients will answer a questionnaire of personal dates and will have an evaluation fiche, in which will be written down: age, index of corporal mass (IMC), index of Lesquene, index WOMAC (Western Ontario and Mac Master), personal and familiar date of the diagnosis, antecedents, instituted treatments, date of the last x-ray, radiological classification of the osteoarthritis according to Scale of Kellgren, electromiographics date and seeming of the postural evaluation. For the electromiographic evaluation the activity of the muscles vastus lateralis and medial oblique in the isometric contraction maximum volunteer (ICMV) and in the march will be analyzed. And for the postural evaluation will be made three photographs in the sights previous frontal and sagittal right and left, being that, for the analysis of the posturais alterations the program will be used SAPO (software for postural evaluation - version 0.63).
In the analysis descriptive statistics the average, medium and shunting line will be used standard. The level of significance will be established in α < 0,05.
- Conditions
- Osteoarthritis
- Keywords
- Osteoarthritis, posture, knee
- Medical subject headings
- Osteoarthritis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2009 (estimated)
- Study startFeb 2006
- Primary completionJun 2008
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Investigators
- Luciano Sencovici, Principal investigator, USP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01031576
- Sponsor's protocol ID
- 12345
- Status last verified
- Apr 2008
- First submitted
- 2 Apr 2008
- Last updated
- 14 Dec 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postural Analysis and Eletromiographic Activity in Patients With Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT01031576
- Acronym / sponsor ID
- 12345
- Conditions
- Osteoarthritis
- Keywords
- Osteoarthritis, posture, knee
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Feb 2006
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 14 Dec 2009 (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.
Osteoarthritis is the result of the degeneration of the cartilage to articulate, being currently considered as having an multifactorial cause.The knees are one of the affected joints more due to overload that constitutes the main activator or determinative mechanism for the development of the illness. Beyond pain it has important reduction of the amplitude of movement and the muscular force that causes functional limitation and posture's alterations intervening with the activities of daily life. Therefore, the main objective of this study will be to characterize the posture's alterations and the electromiographic activity in patients with osteoarthritis of knees. For this study 30 citizens will be evaluated, 15 with diagnosis of OA of knees unilaterally and 15 healthful citizens, both the groups will be of the feminine sex with age between 60 to 80 years. The selected patients will answer a questionnaire of personal dates and will have an evaluation fiche, in which will be written down: age, index of corporal mass (IMC), index of Lesquene, index WOMAC (Western Ontario and Mac Master), personal and familiar date of the diagnosis, antecedents, instituted treatments, date of the last x-ray, radiological classification of the osteoarthritis according to Scale of Kellgren, electromiographics date and seeming of the postural evaluation. For the electromiographic evaluation the activity of the muscles vastus lateralis and medial oblique in the isometric contraction maximum volunteer (ICMV) and in the march will be analyzed. And for the postural evaluation will be made three photographs in the sights previous frontal and sagittal right and left, being that, for the analysis of the posturais alterations the program will be used SAPO.
Detailed description
Osteoarthritis is the result of the degeneration of the cartilage to articulate, being currently considered as having an multifactorial cause. Of the histological point of view it is characterized for alterations of the loss of the natural viscoelasticity, giving to origin the foci of "softening" in the cartilaginous surface that if gets depressed becoming discontinues for the appearance of "fibrillation zones" provoking reaction of the subcondral bone that if condemns in the pressure areas (sclerosis) and proliferates together to the edges of the joint (osteophytic). It is that affect millions of people annually and one of the main and a common condition causes pain functional incapacity generating enormous economic load for the community. The knees are one of the affected joints more due to overload that constitutes the main activator or determinative mechanism for the development of the illness. Beyond pain it has important reduction of the amplitude of movement and the muscular force that causes functional limitation and posture's alterations intervening with the activities of daily life. Therefore, the main objective of this study will be to characterize the posture's alterations and the electromiographic activity in patients with osteoarthritis of knees. For this study 60 citizens will be evaluated, 30 with diagnosis of OA of knees unilaterally and 30 healthful citizens, both the groups will be of the feminine sex with age between 65 to 75 years. The selected patients will answer a questionnaire of personal dates and will have an evaluation fiche, in which will be written down: age, index of corporal mass (IMC), index of Lesquene, index WOMAC (Western Ontario and Mac Master), personal and familiar date of the diagnosis, antecedents, instituted treatments, date of the last x-ray, radiological classification of the osteoarthritis according to Scale of Kellgren, electromiographics date and seeming of the postural evaluation. For the electromiographic evaluation the activity of the muscles vastus lateralis and medial oblique in the isometric contraction maximum volunteer (ICMV) and in the march will be analyzed. And for the postural evaluation will be made three photographs in the sights previous frontal and sagittal right and left, being that, for the analysis of the posturais alterations the program will be used SAPO (software for postural evaluation - version 0.63).
In the analysis descriptive statistics the average, medium and shunting line will be used standard. The level of significance will be established in α < 0,05.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 60 to 80 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 15 with diagnosis of OA of knees unilaterally and 15 healthful citizens, both the groups will be of the feminine sex with age between 65 to 75 years
Key inclusion criteria (1 listed)
- Clinical diagnosis of Osteoarthritis Disease
Key exclusion criteria (1 listed)
- Others Disease orthopedics
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 14 Dec 2009.
Related trials for Osteoarthritis
Recruiting
Oral Nutritional Optimization in Total Joint Arthroplasty
Osteoarthritis
Not yet recruiting
Opioid Reduction and Enhanced Recovery in Orthopaedic Surgery (OREOS)-Knee
Knee Arthroplasty, Total, Partial Knee Arthroplasty
Recruiting
Trans-arterial Embolization for the Treatment of Facet Pain Due to Facet Arthropathy
Facet Joint Arthropathy, Pain
Not yet recruiting
Hybrid Closed Wedge High Tibial Osteotomy
Patello-femoral Osteoarthritis
Recruiting
Effects of Graded Motor Imagery in Individuals With Foot/Ankle Osteoarthritis
Ankle Osteoarthritis, Foot Osteoarthritis
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.
Luciano Sencovici principal investigator
USP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis, run by University of Sao 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 1 inclusion and 1 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 14 Dec 2009. 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.
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.
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 14 Dec 2009.