Knee OsteoarthritisPhase 4NCT00698412
Effectiveness of Cane in Osteoarthritis (OA) Patients
A Phase 4 study testing Cane in people with Knee Osteoarthritis, run by Federal University of São Paulo at 1 site in Brazil.
Trial summary
Sixty four participants were enrolled in a randomized, controlled clinical trial to evaluate the effectiveness of daily cane use on pain, function, quality of life and energy consumption during the gait in patients with knee osteoarthritis. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Cane
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2005to Jul 2007
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary Knee osteoarthritis (ACR criteria)
- VAS for knee pain between 3 and 7
- No changes the NSAID intake or physical activity in the previous 3 months
Who cannot join
- Symptomatic heart or pulmonary disease
- Severe systemic disease
- Other symptomatic disease in the lower limb or in the upper limb that will carry the cane
- Joint injection in the previous 3 months
- PT in the previous 3 months
- Previously cane use
- Start regular physical activity in the last month
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of Daily Cane Use on Pain, Function, Quality of Life and Energy Consumption During the Gait in Patients With Knee Osteoarthritis
Sixty four participants were enrolled in a randomized, controlled clinical trial to evaluate the effectiveness of daily cane use on pain, function, quality of life and energy consumption during the gait in patients with knee osteoarthritis.
Read the detailed description
Treatment, Randomized, Single Blind, Parallel Assignment, Efficacy Study
- Conditions
- Knee Osteoarthritis
- Being tested
- Cane
- Keywords
- Knee osteoarthritis, Daily cane use, Pain, Function, Quality of life, Energy consumption during the gait
- Medical subject headings
- Osteoarthritis, Knee, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CaneDevice
This group use the cane every day since the baseline
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Cane group Receives: Device: Cane |
| 2 | No intervention | Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain - visual analogue scale
Measured: T0, T30 and T60
Secondary outcomes (4)
Function - Lequesne index
Measured: T0, T30 and T60
Function - WOMAC questionnaire
Measured: T0,T30 and T60
Quality of life - SF-36
Measured: T0, T30 and T60
Energy consumption (VO2)- gas analysis with and without cane during the 6MWT
Measured: T0, T30 and T60
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2008 (estimated)
- Study startJan 2005
- Primary completionJul 2007
- Study completionJul 2007
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.
- 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
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Investigators
- Anamaria Jones, PT, Principal investigator, Federal University of São PauloJamil Natour, MD, Study chair, Federal University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00698412
- Sponsor's protocol ID
- UNIFESP-102/2004
- Status last verified
- May 2008
- First submitted
- 13 Jun 2008
- Last updated
- 17 Jun 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Jones A, Silva PG, Silva AC, Colucci M, Tuffanin A, Jardim JR, Natour J. Impact of cane use on pain, function, general health and energy expenditure during gait in patients with knee osteoarthritis: a randomised controlled trial. Ann Rheum Dis. 2012 Feb;71(2):172-9. doi: 10.1136/ard.2010.140178. Epub 2011 Nov 29.
PubMed 22128081
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Daily Cane Use on Pain, Function, Quality of Life and Energy Consumption During the Gait in Patients With Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT00698412
- Acronym / sponsor ID
- UNIFESP-102/2004
- Conditions
- Knee Osteoarthritis
- Keywords
- Knee osteoarthritis, Daily cane use, Pain, Function, Quality of life, Energy consumption during the gait
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Study start
- Jan 2005
- Primary completion
- Jul 2007 (actual)
- Study completion
- Jul 2007 (actual)
- First posted
- 17 Jun 2008 (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.
Sixty four participants were enrolled in a randomized, controlled clinical trial to evaluate the effectiveness of daily cane use on pain, function, quality of life and energy consumption during the gait in patients with knee osteoarthritis.
Detailed description
Treatment, Randomized, Single Blind, Parallel Assignment, Efficacy Study
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: CaneCane group |
| 2 | No intervention | –Control Group |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Primary Knee osteoarthritis (ACR criteria)
- VAS for knee pain between 3 and 7
- No changes the NSAID intake or physical activity in the previous 3 months
Key exclusion criteria (7 listed)
- Symptomatic heart or pulmonary disease
- Severe systemic disease
- Other symptomatic disease in the lower limb or in the upper limb that will carry the cane
- Joint injection in the previous 3 months
- PT in the previous 3 months
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 |
|---|---|---|
| CaneThis group use the cane every day since the baseline | Device | 1 |
Primary outcome
Pain - visual analogue scale
Time frame: T0, T30 and T60
4 secondary outcomes
Function - Lequesne index
Time frame: T0, T30 and T60
Function - WOMAC questionnaire
Time frame: T0,T30 and T60
Quality of life - SF-36
Time frame: T0, T30 and T60
Energy consumption (VO2)- gas analysis with and without cane during the 6MWT
Time frame: T0, T30 and T60
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 17 Jun 2008.
- Derived from this study: PubMed 22128081Jones A, Silva PG, Silva AC, Colucci M, Tuffanin A, Jardim JR, Natour J. Impact of cane use on pain, function, general health and energy expenditure during gait in patients with knee osteoarthritis: a randomised controlled trial. Ann Rheum Dis. 2012 Feb;71(2):172-9. doi: 10.1136/ard.2010.140178. Epub 2011 Nov 29.
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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.
Anamaria Jones, PT principal investigator
Federal University of São Paulo
Jamil Natour, MD study chair
Federal University of São Paulo
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 Cane 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 3 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 17 Jun 2008. 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?
Pain - visual analogue scale (time frame: T0, T30 and T60). 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 NCT00698412, 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 17 Jun 2008.