The purpose of this pilot study is to determine the feasibility of conducting a high quality clinical trial to investigate the effects of low intensity, pulsed ultrasound on knee osteoarthritis pain and physical function.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
1
1.5MHz, spatial average-temporal average intensity = 0.03W/cm2, pulsed (burst frequency 1kHz, burst duration 200µm, duty cycle 20%); self-administered to the medial side of the knee joint while sitting down for 20 minutes every day for 3 months.
no ultrasonic energy emitted; self-administered to the medial side of the knee joint while sitting down for 20 minutes every day for 3 months
Regional Joint Assessment Program - HHS/SJHH
Hamilton, Ontario, Canada
Rate of recruitment
Ability to recruit 30 participants over a 6 month period
Time frame: 6 months
Adherence to study protocol
Percent adherence to the protocols for randomization, recruitment, intervention, and assessment
Time frame: 26 weeks
Rate of retention
Number of participants completing the trial
Time frame: 26 weeks
Rate of all adverse events
Participants will be asked about serious and non-serious adverse events weekly during the 13 week intervention phase and monthly during the 13 week follow up phase. All adverse events will be recorded and addressed as indicated.
Time frame: 26 weeks
Western Ontario and McMaster Osteoarthritis Index (WOMAC)3.1NPR pain subscale
Change from baseline in pain at 13 weeks
Time frame: 13 weeks
Western Ontario and McMaster Osteoarthritis Index (WOMAC)3.1NPR physical function subscale
Change from baseline in Physical Function at 26 weeks
Time frame: 26 weeks
6 Minute Walk Test (6MWT)
Change from baseline distance (metres) walked in 6 minutes at 26 weeks
Time frame: 26 weeks
SF-36 (RAND 36-item Health Survey 1.0)
Change from baseline in Health Related Quality of Life at 26 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 26 weeks
Global Rating of Disease Severity
Change from baseline in Global Rating of Disease Severity at 13 and 26 weeks will be assessed using an 11-point scale ('Considering all the ways that your knee arthritis affects you, please rate how you are doing on a scale from 0 (very well) to 10 (very poor))
Time frame: 26 weeks
11-point Verbal Numeric Rating Scale (VNRS)
Change from baseline in pain intensity (average, minimum and maximum over the past 24 hours and following physical performance tests)
Time frame: 0 and 13 weeks
Lower Extremity Functional Scale (LEFS)
Change from baseline in physical function at 26 weeks
Time frame: 26 weeks
Stair Climb test
Time (seconds) to ascend and descend a staircase with 9 steps
Time frame: 26 weeks
Perceived change
Perceived change from baseline will be assessed at 13 and 26 weeks using an 11-point scale ('With respect to your OA knee treated with ultrasound, how would you describe yourself now compared to baseline assessment?' -5 = a very great deal worse, 0 = about the same, +5 = a very great deal better)
Time frame: 13 and 26 weeks