NCT01623804终止不适用
Can Very Low Intensity Ultrasound Therapy Improve Pain in People With Knee Osteoarthritis? A Pilot Randomized Controlled Trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 2
- 主要终点
- Rate of recruitment
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Rate of recruitment
时间窗: 6 months
Ability to recruit 30 participants over a 6 month period
Adherence to study protocol
时间窗: 26 weeks
Percent adherence to the protocols for randomization, recruitment, intervention, and assessment
Rate of retention
时间窗: 26 weeks
Number of participants completing the trial
Rate of all adverse events
时间窗: 26 weeks
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.
次要结局
- Lower Extremity Functional Scale (LEFS)(26 weeks)
- Western Ontario and McMaster Osteoarthritis Index (WOMAC)3.1NPR pain subscale(13 weeks)
- Western Ontario and McMaster Osteoarthritis Index (WOMAC)3.1NPR physical function subscale(26 weeks)
- 6 Minute Walk Test (6MWT)(26 weeks)
- SF-36 (RAND 36-item Health Survey 1.0)(26 weeks)
- Global Rating of Disease Severity(26 weeks)
- 11-point Verbal Numeric Rating Scale (VNRS)(0 and 13 weeks)
- Stair Climb test(26 weeks)
- Perceived change(13 and 26 weeks)
研究者
研究点 (2)
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