OsteoarthritisNCT00506714
Walking Aids in the Management of Hip Osteoarthritis
A study testing single point cane in people with Osteoarthritis, run by Arthritis Foundation at 1 site in United States.
Trial summary
The purpose of this study is to determine whether or not the use of a nonpharmacologic intervention (single point cane) is effective in the treatment of knee osteoarthritis. Read more about this study
- Who is it for?
- Ages 60 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- single point cane
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2007to Sep 2009
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- hip OA (grades II-IV) of the Kellgren/Lawrence classification
- with pain in one hip for most days of the prior month
- Ability to walk 30 feet without postural sway
- Ability to stand unaided
- Ability to understand verbal instructions
- Ability to give informed consent
Who cannot join
- History of hip or knee trauma or surgery including arthroscopic surgery in the past six months
- Severe obesity (> 300 pounds)
- Neurological disorders that affect lower extremity function such as stroke or peripheral neuropathy, vestibular dysfunction or poor vision
- Injury or amputation to the lower extremity joints
- History of other types of arthritis or fibromyalgia
- Pain from spine, knee, ankle, or foot disease that would interfere with assessment of the hip
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- Poor health that would impair compliance or assessment such as shortness of breath with exertion, chest pain
- Foot deformities such as hallux rigidus, valgus deformity of the midfoot, previous ankle arthrodesis
- Greater trochanteric pain syndrome
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine whether or not the use of a nonpharmacologic intervention (single point cane) is effective in the treatment of knee osteoarthritis.
Read the detailed description
Osteoarthritis (OA), the most common joint disease in humans, is a significant cause of pain and disability. Non-pharmacological treatments for hip OA include education, exercise, appliances (walking sticks or insoles), and weight reduction if obese or overweight. Canes are often recommended to reduce adverse forces across joints although there is currently no research evidence regarding the efficacy of walking sticks for hip OA. Little information is available regarding the impact of walking aids on psychosocial function and quality of life in individuals with hip OA. This study will evaluate the effects of walking aids in hip OA by examining gait biomechanics, quality of life, pain, and opinions regarding using a cane.
Comparisons: Compare gait biomechanics in people with symptomatic unilateral hip OA while walking with and without a cane at baseline and after 4 weeks of cane use. Compare gait biomechanics in people with symptomatic unilateral hip OA with and without a cane to those of healthy, age-matched controls. Compare pain and health-related quality of life in people with symptomatic unilateral hip OA following 4 weeks of cane use. Determine the association between changes in gait biomechanics, pain, and health-related quality of life in people with symptomatic unilateral hip OA following 4 weeks of cane use.
- Conditions
- Osteoarthritis
- Being tested
- single point cane
- Keywords
- Osteoarthritis, Walking Sticks, Canes
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
single point caneDevice
Adjustable single point cane with SureGrip handle
| Study group | Role | What they receive |
|---|---|---|
| Adult subjects with hip osteoarthritis | Experimental | Walk with and without a single point cane at baseline and after four weeks Receives: Device: single point cane |
| Healthy Subjects | No intervention | Healthy adults walking without a cane at baseline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gait Velocity
Measured: Baseline
Secondary outcomes (2)
Gait Velocity With a Cane in Hip OA Subjects
Measured gait velocity when hip OA subjects walked with a cane at the baseline visit.
Measured: Baseline
Gait Velocity
Gait velocity when adults with symptomatic hip osteoarthritis walked with a cane after four weeks of cane use
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2007 (estimated)
- Study startJul 2007
- Primary completionJul 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arthritis Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Meika A. Fang, MD, Arthritis Foundation
- Investigators
- Meika A Fang, MD, Principal investigator, VA Greater Los Angeles Healthcare System Department of Medicine; UCLA Department of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00506714
- Sponsor's protocol ID
- 2007-030430
- Status last verified
- Sep 2012
- First submitted
- 20 Jul 2007
- Last updated
- 4 Oct 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Walking Aids in the Management of Hip Osteoarthritis
- ClinicalTrials.gov ID
- NCT00506714
- Acronym / sponsor ID
- 2007-030430
- Conditions
- Osteoarthritis
- Keywords
- Osteoarthritis, Walking Sticks, Canes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Arthritis FoundationUniversity, hospital or other
- Study start
- Jul 2007
- Primary completion
- Jul 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 25 Jul 2007 (estimated)
- Results
- Posted 28 Sep 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether or not the use of a nonpharmacologic intervention (single point cane) is effective in the treatment of knee osteoarthritis.
Detailed description
Osteoarthritis (OA), the most common joint disease in humans, is a significant cause of pain and disability. Non-pharmacological treatments for hip OA include education, exercise, appliances (walking sticks or insoles), and weight reduction if obese or overweight. Canes are often recommended to reduce adverse forces across joints although there is currently no research evidence regarding the efficacy of walking sticks for hip OA. Little information is available regarding the impact of walking aids on psychosocial function and quality of life in individuals with hip OA. This study will evaluate the effects of walking aids in hip OA by examining gait biomechanics, quality of life, pain, and opinions regarding using a cane.
Comparisons: Compare gait biomechanics in people with symptomatic unilateral hip OA while walking with and without a cane at baseline and after 4 weeks of cane use. Compare gait biomechanics in people with symptomatic unilateral hip OA with and without a cane to those of healthy, age-matched controls. Compare pain and health-related quality of life in people with symptomatic unilateral hip OA following 4 weeks of cane use. Determine the association between changes in gait biomechanics, pain, and health-related quality of life in people with symptomatic unilateral hip OA following 4 weeks of cane use.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adult subjects with hip osteoarthritis | Experimental | Device: single point caneWalk with and without a single point cane at baseline and after four weeks |
| Healthy Subjects | No intervention | –Healthy adults walking without a cane at baseline |
Who may qualify
- Ages
- 60 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- hip OA (grades II-IV) of the Kellgren/Lawrence classification
- with pain in one hip for most days of the prior month
- Ability to walk 30 feet without postural sway
- Ability to stand unaided
- Ability to understand verbal instructions
Key exclusion criteria (9 listed)
- History of hip or knee trauma or surgery including arthroscopic surgery in the past six months
- Severe obesity (> 300 pounds)
- Neurological disorders that affect lower extremity function such as stroke or peripheral neuropathy, vestibular dysfunction or poor vision
- Injury or amputation to the lower extremity joints
- History of other types of arthritis or fibromyalgia
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 |
|---|---|---|
| single point caneAdjustable single point cane with SureGrip handle | Device | Adult subjects with hip osteoarthritis |
Primary outcome
Gait Velocity
Time frame: Baseline
2 secondary outcomes
Gait Velocity With a Cane in Hip OA Subjects
Time frame: Baseline
Gait Velocity
Time frame: 4 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Meika A Fang, MD principal investigator
VA Greater Los Angeles Healthcare System Department of Medicine; UCLA Department of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing single point cane in people with Osteoarthritis, run by Arthritis Foundation at 1 site in United States.
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 6 inclusion and 9 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 4 Oct 2012. 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 United States. 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?
Yes. Results are posted in the registry (first posted 28 Sep 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Gait Velocity (time frame: Baseline). 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 4 Oct 2012.