OsteoarthritisNCT00415259
Effects of Shoes Insoles on Symptoms and Disease Progression in Knee Osteoarthritis
A study testing Laterally wedged shoe insoles in people with Osteoarthritis, run by University of Melbourne at 1 site in Australia.
Trial summary
It is hypothesised that laterally wedged insoles will result in reduced knee pain and cartilage volume loss after 12 months of wear, compared to control insoles. People with symptomatic knee osteoarthritis will be recruited from the community and randomised to wear either laterally wedged insoles or control insoles… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Laterally wedged shoe insoles
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteAustralia
- Study dates
- May 2005to Dec 2008
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Eligibility will be confirmed by radiographic and clinical examination
- People with medial tibiofemoral joint OA fulfilling American College of Rheumatology classification criteria and reporting average knee pain on walking >3 on an 11-point scale
- varus knee malalignment on standing anteroposterior lower limb x-ray.
Who cannot join
- advanced radiographic knee OA (Kellgren and Lawrence stage 4
- knee surgery or intra-articular corticosteroid injection within 6 months
- current or past (within 4 weeks) oral corticosteroid use
- systemic arthritic conditions
- history of tibiofemoral/patellofemoral joint replacement or tibial osteotomy
- any other muscular, joint or neurological condition affecting lower limb function
Show all 9Show fewer
- ankle/foot pathology or pain that precludes the use of insoles
- use of foot orthotics within past 6 months and
- use of footwear that does not accomodate an insole.
Trial locations and contacts
1 site in 1 country.
Australia1 site
Centre for Health Exercise & Sports Medicine, School of Physiotherapy, The University of Melbourne
Melbourne, Victoria, 3010
About this study
It is hypothesised that laterally wedged insoles will result in reduced knee pain and cartilage volume loss after 12 months of wear, compared to control insoles. People with symptomatic knee osteoarthritis will be recruited from the community and randomised to wear either laterally wedged insoles or control insoles for 12 months. Patients will be assessed at baseline and at 12 months.
- Conditions
- Osteoarthritis
- Being tested
- Laterally wedged shoe insoles, Control insole group
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laterally wedged shoe insolesDevice
Full-length 5 degree lateral wedged insoles worn inside the shoes daily for 12 months
Control insole groupDevice
Flat control insoles worn inside the shoes daily for 12 months
| Study group | Role | What they receive |
|---|---|---|
| Laterally wedged shoe insoles | Experimental | Full-length 5 degree lateral wedged insoles worn inside the shoes daily for 12 months Receives: Device: Laterally wedged shoe insoles |
| Flat control insoles | Other | Not described Receives: Device: Control insole group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee pain via a visual analogue scale
Measured: Measured at baseline and 12 months
Disease progression via MRI measurements of knee cartilage volume
Measured: Measured at baseline and 12 months
Secondary outcomes (4)
Western Ontario and McMaster Universities (WOMAC) Oestoarthritis Index
Measured: Measured at baseline and 12 months
Patient perceived response to treatment
Measured: Measured at baseline and 12 months.
Health-related quality-of-life (via SF-36, AQoL questionnaires)
Measured: Measured at baseline and 12 months
Recorded use of health care
Measured: Measured at baseline and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2006 (estimated)
- Study startMay 2005
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Melbourne
- Sponsor type
- University, hospital or other
- Collaborators
- National Health and Medical Research Council, Australia
- Responsible party
- Principal investigator, Kim Bennell, University of Melbourne
- Investigators
- Kim Bennell, PhD, Principal investigator, University of Melbourne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00415259
- Sponsor's protocol ID
- 350297
- Status last verified
- Jan 2013
- First submitted
- 21 Dec 2006
- Last updated
- 17 Jan 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Bennell KL, Bowles KA, Payne C, Cicuttini F, Williamson E, Forbes A, Hanna F, Davies-Tuck M, Harris A, Hinman RS. Lateral wedge insoles for medial knee osteoarthritis: 12 month randomised controlled trial. BMJ. 2011 May 18;342:d2912. doi: 10.1136/bmj.d2912.
PubMed 21593096Bennell K, Bowles KA, Payne C, Cicuttini F, Osborne R, Harris A, Hinman R. Effects of laterally wedged insoles on symptoms and disease progression in medial knee osteoarthritis: a protocol for a randomised, double-blind, placebo controlled trial. BMC Musculoskelet Disord. 2007 Sep 24;8:96. doi: 10.1186/1471-2474-8-96.
PubMed 17892539
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Shoes Insoles on Symptoms and Disease Progression in Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT00415259
- Acronym / sponsor ID
- 350297
- Conditions
- Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University of MelbourneUniversity, hospital or other
- Collaborators
- National Health and Medical Research Council, Australia
- Study start
- May 2005
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 22 Dec 2006 (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.
It is hypothesised that laterally wedged insoles will result in reduced knee pain and cartilage volume loss after 12 months of wear, compared to control insoles. People with symptomatic knee osteoarthritis will be recruited from the community and randomised to wear either laterally wedged insoles or control insoles for 12 months. Patients will be assessed at baseline and at 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laterally wedged shoe insoles | Experimental | Device: Laterally wedged shoe insolesFull-length 5 degree lateral wedged insoles worn inside the shoes daily for 12 months |
| Flat control insoles | Other | Device: Control insole group |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Eligibility will be confirmed by radiographic and clinical examination
- People with medial tibiofemoral joint OA fulfilling American College of Rheumatology classification criteria and reporting average knee pain on walking >3 on an 11-point scale
- varus knee malalignment on standing anteroposterior lower limb x-ray.
Key exclusion criteria (9 listed)
- advanced radiographic knee OA (Kellgren and Lawrence stage 4
- knee surgery or intra-articular corticosteroid injection within 6 months
- current or past (within 4 weeks) oral corticosteroid use
- systemic arthritic conditions
- history of tibiofemoral/patellofemoral joint replacement or tibial osteotomy
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 |
|---|---|---|
| Laterally wedged shoe insolesFull-length 5 degree lateral wedged insoles worn inside the shoes daily for 12 months | Device | Laterally wedged shoe insoles |
| Control insole groupFlat control insoles worn inside the shoes daily for 12 months | Device | Flat control insoles |
Primary outcome
Knee pain via a visual analogue scale
Time frame: Measured at baseline and 12 months
Disease progression via MRI measurements of knee cartilage volume
Time frame: Measured at baseline and 12 months
4 secondary outcomes
Western Ontario and McMaster Universities (WOMAC) Oestoarthritis Index
Time frame: Measured at baseline and 12 months
Patient perceived response to treatment
Time frame: Measured at baseline and 12 months.
Health-related quality-of-life (via SF-36, AQoL questionnaires)
Time frame: Measured at baseline and 12 months
Recorded use of health care
Time frame: Measured at baseline and 12 months
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 Jan 2013.
- Derived from this study: PubMed 21593096Bennell KL, Bowles KA, Payne C, Cicuttini F, Williamson E, Forbes A, Hanna F, Davies-Tuck M, Harris A, Hinman RS. Lateral wedge insoles for medial knee osteoarthritis: 12 month randomised controlled trial. BMJ. 2011 May 18;342:d2912. doi: 10.1136/bmj.d2912.
- Derived from this study: PubMed 17892539Bennell K, Bowles KA, Payne C, Cicuttini F, Osborne R, Harris A, Hinman R. Effects of laterally wedged insoles on symptoms and disease progression in medial knee osteoarthritis: a protocol for a randomised, double-blind, placebo controlled trial. BMC Musculoskelet Disord. 2007 Sep 24;8:96. doi: 10.1186/1471-2474-8-96.
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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.
Kim Bennell, PhD principal investigator
University of Melbourne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laterally wedged shoe insoles in people with Osteoarthritis, run by University of Melbourne at 1 site in Australia.
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 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 17 Jan 2013. 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 Australia. 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?
Knee pain via a visual analogue scale (time frame: Measured at baseline and 12 months). 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 NCT00415259, which also lists 2 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 17 Jan 2013.