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Trial registered on ANZCTR


Registration number
ACTRN12610000391077
Ethics application status
Approved
Date submitted
23/02/2010
Date registered
14/05/2010
Date last updated
14/05/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effectiveness of foot orthoses for knee pain
Scientific title
The effect of prefabricated foot orthoses on pain and function in individuals with patellofemoral pain syndrome
Secondary ID [1] 251773 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Patellofemoral pain (knee pain) 256870 0
Condition category
Condition code
Musculoskeletal 257021 257021 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Each participant will be prescribed a pair of prefabricated foot orthoses. They will be required to wear them as often as possible for a period of 12 weeks
Intervention code [1] 256064 0
Treatment: Devices
Comparator / control treatment
NA - no control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 257913 0
Patient perceived clinical success Likert scale (markedly better, moderately better, same, moderately worse or markedly worse)
Timepoint [1] 257913 0
6 and 12 weeks after intervention commencement
Secondary outcome [1] 263388 0
Anterior knee pain scale
Timepoint [1] 263388 0
6 and 12 weeks after intervention commencement
Secondary outcome [2] 263389 0
Lower extremity functional scale
Timepoint [2] 263389 0
6 and 12 weeks after intervention commencement
Secondary outcome [3] 263390 0
100 mm pain visual analogue scale ancored by 'no pain' and 'worst pain imaginable' for usual and worst pain in the previous week
Timepoint [3] 263390 0
6 and 12 weeks after intervention commencement
Secondary outcome [4] 263391 0
Change in the number of pain free step downs and single leg rises able to be completed
Timepoint [4] 263391 0
immediately after intervention commencement and 12 weeks later
Secondary outcome [5] 263392 0
Change in pain and ease of completing a single leg squat on a 5 point Likert scale:
Pain (markedly better, somewhat better, same, somewhat worse, markedly worse)
Ease (markedly easier, somewhat easier, same, somewhat harder, markedly harder)
Timepoint [5] 263392 0
immediately after intervention and 12 weeks later

Eligibility
Key inclusion criteria
1. Aged 18 – 35 years old
2. Insidious onset of peripatellar or retropatellar knee pain of at least 6 weeks duration
3. Worst pain in the previous week of at least 30 mm on a 100 mm visual analogue scale
4. Pain provoked by at least two activities from running, walking, hopping, squatting, stair negotiation, kneeling, or prolonged sitting
5. Pain elicited by patellar palpation, patellofemoral joint (PFJ) compression or resisted isometric quadriceps contraction
Minimum age
18 Years
Maximum age
35 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Use of foot orthoses in the previous five years
2. Physiotherapy treatment in the previous six months
3. Current use of anti-inflammatory medications
4. Concomitant injury or pain arising from the lumbar spine or hip
5. Knee internal derangement
6. Knee ligament insufficiency
7. Previous knee surgery
8. PFJ instability; or patellar tendinopathy.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
All potential participants first give written informed consent. Potential participants are screened by a registered physiotherapist to ensure eligibility. All participant eligible were then administered the same ype of prefabricated foot orthoses
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
NA
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 256568 0
University
Name [1] 256568 0
Musculoskeletal Research Centre
Address [1] 256568 0
La Trobe University Bundoora, Victoria, 3086
Country [1] 256568 0
Australia
Primary sponsor type
University
Name
Musculoskeletal Research Centre
Address
La Trobe University Bundoora, Victoria, 3086
Country
Australia
Secondary sponsor category [1] 255864 0
None
Name [1] 255864 0
Address [1] 255864 0
Country [1] 255864 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258605 0
La Trobe University's Faculty of Health Sciences Human Ethics Committee
Ethics committee address [1] 258605 0
La Trobe University, Bundoora, Victoria, 3086
Ethics committee country [1] 258605 0
Australia
Date submitted for ethics approval [1] 258605 0
Approval date [1] 258605 0
06/08/2008
Ethics approval number [1] 258605 0
FHEC08/102

Summary
Brief summary
Recent research indicates that shoe inserts are effective in treating some individuals with knee pain. However, not all individuals benefit from shoe inserts and research to determine who is most likely to benefit is limited. Therefore, this study is aiming to identify predictors of individuals with knee pain most likely to benefit from shoe inserts.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30873 0
Address 30873 0
Country 30873 0
Phone 30873 0
Fax 30873 0
Email 30873 0
Contact person for public queries
Name 14120 0
Christian Barton
Address 14120 0
Musculoskeletal Research Centre
La Trobe University
Bundoora, Victoria
3086
Country 14120 0
Australia
Phone 14120 0
+61 3 9479 5282
Fax 14120 0
Email 14120 0
c.barton@latrobe.edu.au
Contact person for scientific queries
Name 5048 0
Christian Barton
Address 5048 0
Musculoskeletal Research Centre
La Trobe University
Bundoora, Victoria
3086
Country 5048 0
Australia
Phone 5048 0
+61 3 9479 5282
Fax 5048 0
Email 5048 0
c.barton@latrobe.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary