Impact of Theraworx Foam on Pain and Motion and Patient-Reported Outcomes in Thumb Arthritis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 3
- 主要终点
- Pinch Strength
研究概览
简要总结
Thumb carpometacarpal osteoarthritis (CMC OA) affects up to 33% of people over the age of 40, which leads to inflammation, pain, and weakness of the CMC joint. Treatment modalities are both conservative and surgical with surgical options including osteotomy, bone excision, ligament reconstruction, and various prosthetic implants. The conservative treatment options, however, are limited to NSAIDs and bracing or steroid injections.
Advances in topical therapies have the potential to deliver focused treatment to the CMC joint. Novel treatment of inflammation can potentially reduce inflammation and pain associated with progressing osteoarthritis. Theraworx Relief is an FDA registered foam that has theoretical impact on inflammation reduction in human subjects treated with the topical foam.
详细描述
This pilot study seeks to investigate potential benefit in the use of Theraworx Foam in patients diagnosed with thumb CMC OA. Patients presenting to the upper extremity orthopedic surgery clinic for thumb/hand/wrist pain will be diagnosed by a Board Certified Hand Surgeon as per standard protocols. Patients who are recommended to follow a conservative treatment modality and are interested in participating in this study will be randomized into treatment or control groups. Both groups will undergo symptom assessment, strength testing, and range of motion testing prior to starting the standard conservative treatment of bracing. The treatment group will use the TheraWorx topical foam and the compression wrap nightly for 2 weeks for at least 6 hours per night. Control group will use a compression wrap for the same time period. Both groups will return at 1 and 2 weeks for repeat strength and range of motion testing and symptom assessment.
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
- Single (Participant)
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
- •Thumb CMC arthritis
- •greater than or equal to age 18
- •Interested in non-operative treatment of thumb arthritis
排除标准
- •Recent corticosteroid injection into the thumb joint
- •Non-English speaking
- •skin lesions or rashes on the thumb
- •current use of topical anti-inflammatory medications
- •concomitant thumb/wrist diagnoses that would impact the results (as determined by the PI)
- •known allergy to magnesium
研究组 & 干预措施
Foam and Compression Wrap
Patients will use Theraworx foam and a compression wrap
干预措施: Theraworx (Drug)
Placebo Foam and Compression Wrap
Patients will use placebo foam and a compression wrap
干预措施: Placebo (Drug)
Foam alone
Patients will use Theraworx foam without compression wrap
干预措施: Theraworx (Drug)
结局指标
主要结局
Pinch Strength
时间窗: 2 weeks
This measures pinch strength in pounds (0 is no pinch strength and 40 is maximum pinch strength), mean pinch in pounds reported at 2 weeks
Disabilities of the Arm, Shoulder, and Hand (DASH) Score
时间窗: 2 weeks
patient rated outcome score on scale of 0-100, with 0 being no disability and 100 complete disability, mean value at 2 weeks is reported
Thumb Range of Motion
时间窗: 2 weeks
This measures range of motion of the thumb in degrees from 0-90 degrees (0 degrees would be no motion and 90 degrees full motion), 2 week data is presented as a mean.
Grip Strength
时间窗: 2 weeks
This measures grip strength in pounds (0 is no grip strength 150 is maximum grip strength), mean grip strength in pounds reported at 2 weeks
Numeric Pain Rating Scale
时间窗: 2 weeks
patient rated pain on scale of 0-10 (0 no pain and 10 maximum pain). The mean score at 2 weeks is reported, not the change from baseline.
次要结局
未报告次要终点
研究者
John Fowler
Assistant Professor
University of Pittsburgh