Randomized Trial in knEe Osteoarthritis Using Low Intensity Ultrasound - Evaluating Feasibility (RELIEF)

Study Overview
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Brief Summary
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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.

Official Title
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Can Very Low Intensity Ultrasound Therapy Improve Pain in People With Knee Osteoarthritis? A Pilot Randomized Controlled Trial

Conditions
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Knee Osteoarthritis

Intervention / Treatment
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* Device: low intensity, pulsed ultrasound
* Device: sham ultrasound


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: over 40 years of age; have medial tibiofemoral compartment knee OA; have mild to moderate medial compartment radiographic OA severity (determined by the attending surgeon and/or Advanced Practice Physiotherapist on the basis of a standing x-ray or MRI scan depending upon which is available at initial consult); have stable ('not getting worse or better overall despite short-term fluctuations during the past three months') pain having an average intensity ≥ 3 and ≤ 8 on an 11-point verbal numeric rating scale, VNRS) in one knee which is aggravated by activity and eased with rest; limited pain from other lower extremity joints; and no change in first line pain medication in the past 2 months and willingness to forego alterations in pain medication for the duration of the study unless deemed medically necessary. Exclusion Criteria: history of traumatic OA or previous surgical intervention in the knee or knee effusion; intra-articular injection of the knee in the previous 6 months; received ultrasound treatment for knee OA within the past 6 months; body weight changed ≥ 5% in the past 2 months; level of physical function insufficient to perform the required assessments or administer the intervention (e.g. intermittent claudication, severe peripheral neuropathy, active proliferative retinopathy, unstable cardiac or pulmonary disease, disabling stroke, chronic pain, arthritis in joints other than the study knee, bone fracture in the past 3 months); conditions listed as precautions or unknown safety risks for using the EXOGEN EXPRESS ultrasound device (pregnant or nursing women, individuals with thrombophlebitis, vascular insufficiency, abnormal skin sensitivity, sensory paralysis, open wound at the medial joint line of the knee, taking steroids/anti-coagulants, prescription non-steroidal anti-inflammatory, calcium channel blocker or applying the EXOGEN EXPRESS in close proximity to someone wearing a cardiac pacemaker); unable to read, write and/or understand English; other illness or reasons judged by the participant, clinicians or researchers to make participation inadvisable (e.g. plans to move or travel, cognitive deficit resulting in difficulty comprehending and complying with instructions, caregiving demands/lack of social support for participation); unwillingness to sign informed consent; or participation in a competing study.

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Low intensity, pulsed ultrasound<br> | Device: low intensity, pulsed ultrasound<br>* 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.<br>* Other names: Exogen Express Ultrasound Bone Healing System;|
| Sham Comparator: Sham ultrasound<br> | Device: sham ultrasound<br>* 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<br>* Other names: sham Exogen Express Ultrasound Bone Healing System;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of recruitment | Ability to recruit 30 participants over a 6 month period | 6 months | 
| Adherence to study protocol | Percent adherence to the protocols for randomization, recruitment, intervention, and assessment | 26 weeks | 
| Rate of retention | Number of participants completing the trial | 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. | 26 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Western Ontario and McMaster Osteoarthritis Index (WOMAC)3.1NPR pain subscale | Change from baseline in pain at 13 weeks | 13 weeks | 
| Western Ontario and McMaster Osteoarthritis Index (WOMAC)3.1NPR physical function subscale | Change from baseline in Physical Function at 26 weeks | 26 weeks | 
| 6 Minute Walk Test (6MWT) | Change from baseline distance (metres) walked in 6 minutes at 26 weeks | 26 weeks | 
| SF-36 (RAND 36-item Health Survey 1.0) | Change from baseline in Health Related Quality of Life at 26 weeks | 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)) | 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) | 0 and 13 weeks | 
| Lower Extremity Functional Scale (LEFS) | Change from baseline in physical function at 26 weeks | 26 weeks | 
| Stair Climb test | Time (seconds) to ascend and descend a staircase with 9 steps | 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) | 13 and 26 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ultrasound therapy, Tibiofemoral joint, medial, Nonsurgical