Knee OsteoarthritisPhase 4NCT02049879
Daily Activity After Corticosteroids Injection Among Knee Osteoarthritis Patients
A Phase 4 study testing Corticosteroids injection in people with Knee Osteoarthritis, run by Laval University at 1 site in Canada.
Trial summary
The objective of this study was to objectively measure daily physical activity and spatiotemporal gait pattern, as well as improvements in self reported symptoms and quality of life, before and six weeks after an intra-articular corticosteroids injection in patients suffering from knee osteoarthritis. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Corticosteroids injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2008to Aug 2012
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 50 years old or more
- Medial knee osteoarthritis (Kellgren \& Lawrence Grade I to III)
Who cannot join
- Intra-articular injection during the last six months
- Isolated femoro-patellar arthritis
- Rheumatoid arthritis
- Knee instability
- Spinal stenosis
- Lower limb fracture over the last year
- Lower limb surgery in the last three months
Trial locations and contacts
1 site in 1 country.
Canada1 site
Pavillon de l'Éducation Physique et des Sports - Université Laval
Québec, Quebec, G1V 0A6
About this study
Official title: Quantification of Daily Physical Activity After an Intra-articular Corticosteroid Injection in Patients With Knee Osteoarthritis
The objective of this study was to objectively measure daily physical activity and spatiotemporal gait pattern, as well as improvements in self reported symptoms and quality of life, before and six weeks after an intra-articular corticosteroids injection in patients suffering from knee osteoarthritis. Fourteen patients with unilateral knee osteoarthritis were recruited. The intra-articular corticosteroid injection was given at the end of the second week. Physical activity was objectively measured by an accelerometer worn by the participants for eight weeks. In addition, the Western Ontario and McMaster Universities Arthritis Index (WOMAC), the Medical Outcome Study Short Form-36 (MOS-SF36) and gait trials were completed every two weeks to assess symptoms, quality of life and spatiotemporal parameters of gait.
- Conditions
- Knee Osteoarthritis
- Being tested
- Corticosteroids injection
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Corticosteroids injectionDrug
A solution of triamcinolone 40 mg (Kenalog) mixed with 3 cc of 2% xylocaine without epinephrine.
| Study group | Role | What they receive |
|---|---|---|
| Injection | Experimental | Corticosteroids injection Receives: Drug: Corticosteroids injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Knee pain
Measured: Change from Baseline at 2, 4 and 6 weeks
Change in physical activity
Measured: Change from baseline at 2, 4 and 6 weeks
Secondary outcomes (2)
Change in function and quality of life
Assessment with WOMAC and MOS-SF36 questionnaires
Measured: Change from baseline at 2, 4 and 6 weeks
Change in Spatiotemporal gait parameters
Gait symmetry was verified with regards to the swing and stance phase durations and step length
Measured: Change from Baseline at 2, 4 and 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2014 (estimated)
- Study startNov 2008
- Primary completionAug 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 Laval UniversityThe 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laval University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Philippe Corbeil, Laval University
- Investigators
- Philippe Corbeil, PhD, Study director, Laval UniversityYoann Dessery, MSc, Principal investigator, Laval UniversityÉtienne Belzile, MD, Study director, Laval University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02049879
- Sponsor's protocol ID
- INF-2010
- Status last verified
- Feb 2014
- First submitted
- 28 Jan 2014
- Last updated
- 3 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Dessery Y, Belzile EL, Turmel S, Dore J, Diallo B, Corbeil P. Modulation of physical activity to optimize pain sensation following an intra-articular corticosteroid injection in patients with knee osteoarthritis. ScientificWorldJournal. 2014;2014:209165. doi: 10.1155/2014/209165. Epub 2014 Nov 16.
PubMed 25478585
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantification of Daily Physical Activity After an Intra-articular Corticosteroid Injection in Patients With Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT02049879
- Acronym / sponsor ID
- INF-2010
- Conditions
- Knee Osteoarthritis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Laval UniversityUniversity, hospital or other
- Study start
- Nov 2008
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 30 Jan 2014 (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.
The objective of this study was to objectively measure daily physical activity and spatiotemporal gait pattern, as well as improvements in self reported symptoms and quality of life, before and six weeks after an intra-articular corticosteroids injection in patients suffering from knee osteoarthritis. Fourteen patients with unilateral knee osteoarthritis were recruited. The intra-articular corticosteroid injection was given at the end of the second week. Physical activity was objectively measured by an accelerometer worn by the participants for eight weeks. In addition, the Western Ontario and McMaster Universities Arthritis Index (WOMAC), the Medical Outcome Study Short Form-36 (MOS-SF36) and gait trials were completed every two weeks to assess symptoms, quality of life and spatiotemporal parameters of gait.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Injection | Experimental | Drug: Corticosteroids injectionCorticosteroids injection |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 50 years old or more
- Medial knee osteoarthritis (Kellgren \& Lawrence Grade I to III)
Key exclusion criteria (7 listed)
- Intra-articular injection during the last six months
- Isolated femoro-patellar arthritis
- Rheumatoid arthritis
- Knee instability
- Spinal stenosis
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 |
|---|---|---|
| Corticosteroids injectionA solution of triamcinolone 40 mg (Kenalog) mixed with 3 cc of 2% xylocaine without epinephrine. | Drug | Injection |
Primary outcome
Change in Knee pain
Time frame: Change from Baseline at 2, 4 and 6 weeks
Change in physical activity
Time frame: Change from baseline at 2, 4 and 6 weeks
2 secondary outcomes
Change in function and quality of life
Time frame: Change from baseline at 2, 4 and 6 weeks
Change in Spatiotemporal gait parameters
Time frame: Change from Baseline at 2, 4 and 6 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 3 Mar 2014.
- Derived from this study: PubMed 25478585Dessery Y, Belzile EL, Turmel S, Dore J, Diallo B, Corbeil P. Modulation of physical activity to optimize pain sensation following an intra-articular corticosteroid injection in patients with knee osteoarthritis. ScientificWorldJournal. 2014;2014:209165. doi: 10.1155/2014/209165. Epub 2014 Nov 16.
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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.
Philippe Corbeil, PhD study director
Laval University
Yoann Dessery, MSc principal investigator
Laval University
Étienne Belzile, MD study director
Laval University
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 Corticosteroids injection in people with Knee Osteoarthritis, run by Laval University at 1 site in Canada.
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 7 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 3 Mar 2014. 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 Canada. 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 Knee pain (time frame: Change from Baseline at 2, 4 and 6 weeks). The study lists 2 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 NCT02049879, which also lists 1 linked publication.
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 3 Mar 2014.