Ultra Probe Laser System Osteoarthritis of the Hand Clinical Study.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 6
- 主要终点
- Hand pain rating on the VAS at 10 days after treatment onset.
研究概览
简要总结
The purpose of this study is to determine whether low level light therapy is effective in the treatment of osteoarthritis of the hand, when the treatment is applied to the hand by an individual in his or her own home.
详细描述
Osteoarthritis of the hand is a disease that breaks down the cartilage and causes formation of new bone around the joints of the hand, resulting in pain, discomfort, and often lowered ability to move the affected joints. Existing methods of treatment for osteoarthritis of the hand include oral and topical medications, physical therapy, occupational therapy, assistive device use, braces and surgery. This study is intended to evaluate the effectiveness of at-home use of a low level laser device in reducing the symptoms of osteoarthritis of the hand.
Comparison(s): Active low level laser units in addition to rescue pain medication, compared to non-active ('fake') low level laser units in addition to rescue pain medication.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical and radiographic diagnosis of osteoarthritis of the hand.
- •Hand symptoms such as pain, aching and stiffness present across the prior six months.
- •Willingness to use only Tylenol to relieve hand symptoms during the study.
- •Primary spoken language is English.
排除标准
- •Current use of narcotics, opiates, morphine, steroids.
- •Previous surgery to the hand.
- •Infection or wound in the hand.
- •Involvement in litigation, worker's compensation claim or receiving disability benefits because of osteoarthritis of the hand.
- •Participation in a research study during the prior 90 days.
- •Pregnant or lactating.
结局指标
主要结局
Hand pain rating on the VAS at 10 days after treatment onset.
次要结局
- Hand pain rating on the VAS at 6 weeks after treatment onset,
- Hand Range of Motion measurements at 10 days after treatment onset and at 6 weeks after treatment onset,
- Rescue medication use at 10 days after treatment onset and at 6 weeks after treatment onset,
- Scores on the Michigan Hand Outcomes Questionnaire at 10 days after treatment onset and at 6 weeks after treatment onset,
- Study outcome satisfaction rating at 10 days after treatment onset and at 6 weeks after treatment onset,
- Perceived group assignment by subjects at 10 days after treatment onset and at 6 weeks after treatment onset.