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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00415259




Registration number
NCT00415259
Ethics application status
Date submitted
21/12/2006
Date registered
22/12/2006
Date last updated
17/01/2013

Titles & IDs
Public title
Effects of Shoes Insoles on Symptoms and Disease Progression in Knee Osteoarthritis
Scientific title
Effects of Shoes Insoles on Symptoms and Disease Progression in Knee Osteoarthritis
Secondary ID [1] 0 0
350297
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoarthritis 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Laterally wedged shoe insoles
Treatment: Devices - Control insole group

Experimental: Laterally wedged shoe insoles - Full-length 5 degree lateral wedged insoles worn inside the shoes daily for 12 months

Other: Flat control insoles -


Treatment: Devices: Laterally wedged shoe insoles
Full-length 5 degree lateral wedged insoles worn inside the shoes daily for 12 months

Treatment: Devices: Control insole group
Flat control insoles worn inside the shoes daily for 12 months
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Knee pain via a visual analogue scale
Timepoint [1] 0 0
Measured at baseline and 12 months
Primary outcome [2] 0 0
Disease progression via MRI measurements of knee cartilage volume
Timepoint [2] 0 0
Measured at baseline and 12 months
Secondary outcome [1] 0 0
Western Ontario and McMaster Universities (WOMAC) Oestoarthritis Index
Timepoint [1] 0 0
Measured at baseline and 12 months
Secondary outcome [2] 0 0
Patient perceived response to treatment
Timepoint [2] 0 0
Measured at baseline and 12 months.
Secondary outcome [3] 0 0
Health-related quality-of-life (via SF-36, AQoL questionnaires)
Timepoint [3] 0 0
Measured at baseline and 12 months
Secondary outcome [4] 0 0
Recorded use of health care
Timepoint [4] 0 0
Measured at baseline and 12 months

Eligibility
Key inclusion criteria
- 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.
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- 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

- 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/05/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2008
Sample size
Target
Accrual to date
Final
200
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Centre for Health Exercise & Sports Medicine, School of Physiotherapy, The University of Melbourne - Melbourne
Recruitment postcode(s) [1] 0 0
3010 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
University of Melbourne
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
National Health and Medical Research Council, Australia
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief 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 for 12 months. Patients will be assessed
at baseline and at 12 months.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00415259
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Kim Bennell, PhD
Address 0 0
University of Melbourne
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00415259