The primary objective of this trial is to demonstrate the ability of a full length foam insole to provide relief from pain due to osteoarthritis of the knee or general knee pain when used in foot wear for a 4-week period of time. The secondary objectives comprise the evaluation of the insole's ability to provide appropriate shoe fit and comfort as well as relief from osteoarthritis/ general knee pain after short-term use. The safety and tolerability of the test articles in terms of adverse events (AE) will also be investigated.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
89
Full length foam insole
Focus & Testing, Inc.
Calabasas, California, United States
The Wolf Group
Cincinnati, Ohio, United States
Osteoarthritis knee pain according to Visual Analog Scale
100 mm Visual Analog Scale: 0 = no pain to 100 = worst pain possible
Time frame: Up to 4 weeks
General anterior knee pain according to Visual Analog Scale
100 mm Visual Analog Scale: 0 = no pain to 100 = worst pain possible
Time frame: Up to 4 weeks
Foot Comfort according to Likert scale
7-point Comfort/ Discomfort Likert scale, ranging from 1 = Extreme Discomfort to 7 = Extreme Comfort
Time frame: Up to 4 weeks
Shoe Fit according to Likert scale
7-point Comfort/ Discomfort Likert scale, ranging from -3 = Much too loose fit to 3 = Much too tight fit
Time frame: Up to 4 weeks
Number of subjects with adverse events
Time frame: Up to 4 weeks
Number of subjects with serious adverse events
Time frame: Up to 4 weeks
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