Data

FOLK BMJ Open 2022

The University of Melbourne

Dataset description

Demographic, baseline and 6-month follow-up data from the FOLK trial. 40 patients aged over 50 years with symptomatic radiographic lateral tibiofemoral knee osteoarthritis. Intervention was motion control (n = 18) or neutral shoes (n = 22) and advised to wear them >6 hours/day over 6 months. All data presented in the results paper (BMJ Open. 2022;12(9):e061627) available in XLSX format
Click to explore relationships graph

Related Datasets

Source Study

Trial acronym

FOLK

Trial ID

ACTRN12618001864213

Purpose

Treatment

Phase

Not Applicable

Funding

Government body,National Health and Medical Research Council

Scientific enquiries

Prof Rana Hinman

Brief Summary

We are conducting a research study to compare the effects of daily use of motion-control and neutral walking shoes on lateral tibiofemoral osteoarthritis clinical outcomes, over 6 months. To do this we will randomly allocate participants to receive either i) motion-control or; ii) neutral walking shoes. Participants will be provided a pair of shoes from their allocated group, to be worn daily for 6 months (minimum of 6 hours/day).

Key Inclusion Criteria

i) aged 50 years or older; ii) report knee pain on most days of the past month; iii) report a minimum pain score of 4 on an 11-point numeric rating scale during walking over the previous week; iv) demonstrate Grade 2-4 tibiofemoral osteoarthritis on x-ray as determined by the Kellgren & Lawrence grading system; and v) demonstrate grade of lateral tibiofemoral joint space narrowing greater than medial tibiofemoral joint space narrowing according to a radiographic atlas (where Grade 0=no narrowing ....
Read more

Key Exclusion Criteria

i) suffered knee pain for <3 months; ii) recent knee surgery (past 6 months) or planned surgery in next 6 months; iii) current use of shoe orthoses, customized shoes or ankle/knee braces; iv) current primary use of high heels, thongs or work boots that would restrict ability to wear study shoes 6 hours/day; v) had a hip or knee replacement on most painful knee; vi) had a high tibial osteotomy on most painful knee; vii) had any knee injections in the past 3 months or planned injections in next 6 ....
Read more

Can healthy volunteers participate?

No

 

Population

Sample Size    40

Min. age    50 Years

Max. age    No limit

Sex    Both males and females

Condition category    Knee Osteoarthritis

Condition code    Musculoskeletal

Intervention

Intervention code Treatment: Devices

This pragmatic comparative effectiveness trial will compare two different types of walking shoes manufactured by Asics. Following baseline assessment, participants will be randomly allocated to receive either i) motion-control or; ii) neutral walking shoes. Participants will be provided a pair of shoes from their allocated group, to be worn daily for 6 months (minimum of 6 hours/day), after which participants will be reassessed remotely via paper or web-based questionnaires. Motion-control shoes ....
Read more

Comparison

Control group Active

The comparator shoe will be the neutral walking shoes. These shoes have a mono-density mid-sole (i.e. equal medial and lateral stiffness).

Outcomes

Outcome: Severity of knee pain while walking Scored on an 11-point numerical rating scale (NRS) for average overall pain on walking in the last week.
Timepoint: Baseline, and 6 months after randomization

Study Protocol: Not Available
Data Dictionary: Data dictionary

Will individual participant data (IPD) for this trial be available?

yes

What data in particular will be shared?

All data published in the results paper will be made available (Paterson KL, et al. BMJ Open 2022;12:e061627. doi:10.1136/bmjopen-2022-061627).

When will data be available?

6/9/2022 - 6/9/2037 (a period of 15 years from publication)

Available to whom?

Data will be made available to researchers as required for specific, approved analyses. Data will be provided from locked, cleaned, and de- identified study database. Requests will be reviewed by the Principal Investigator prior to approval.

Available for what types of analyses?

The investigators endorse the concept of data sharing to advance medical science. All requests for data sharing will be reviewed by the Principal Investigator to ensure no conflict with any planned sub analyses and to ensure that the data are shared in an ethical and protected manner. Analyses aimed to improve treatment of knee osteoarthritis for non-commercial purposes are eligible.

Source study information is derived from the Australian New Zealand Clinical Trials Registry (ANZCTR). For more information on the ANZCTR, please see anzctr.org.au