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临床试验/NCT01827306
NCT01827306已完成不适用

Effectiveness of Biofreeze® on Shoulder Pain and In-office Exercise Performance: A Preliminary Pilot Study

Sport and Spine Rehab Clinical Research Foundation1 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2013年3月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
34
试验地点
1
主要终点
Change From Baseline of American Shoulder and Elbow Surgeons (ASES) Questionnaire at 2 Weeks

研究概览

简要总结

Biofreeze® is a topical analgesic, frequently used in the office or given to a patient for home use as a way to mitigate pain during the course of treatment. Rehabilitative exercises are considered an important component of care for shoulder pain patients, although pain can be a limiting factor in the advancement of rehabilitation. The purpose of this study is to evaluate the addition of Biofreeze® to an in-office group of shoulder pain patients to determine its impact on pain reduction. Methods: Patients 18-64 years old with mechanical shoulder pain who are candidates for standard shoulder therapy will be randomized into two groups (N=20). The Control group (N=10) will receive standard shoulder therapy alone while the Intervention group (N=10) will receive standard shoulder therapy plus Biofreeze® just prior to initiating the in-office exercise program. Values of pain (NPRS) and disability (ASES) will be recorded at baseline, 2 weeks, and 4 weeks. Hypotheses will be addressed by repeated measures ANOVAs within and between group, time, and interaction main effects. Clinical Relevance: Progression of therapeutic exercises can be limited by pain and the associated disability. The ability to decrease shoulder pain and disability with a topical analgesic will allow health care professionals to advance patients through a therapeutic exercise program without the restriction of pain. In turn, patients will correct the underlying condition of their shoulder pain at a faster rate.

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
None

入排标准

年龄范围
18 Years 至 64 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 18-64 years old
  • mechanical shoulder pain
  • candidates for conservative care

排除标准

  • pregnancy
  • radicular symptoms
  • not a candidate for conservative care
  • history of recent shoulder surgery

研究组 & 干预措施

Biofreeze

Active Comparator

Apply 5 minutes before therapy by applying a small coin sized amount to the painful area. Subjects will then complete a standard shoulder therapy program.

干预措施: Biofreeze (Drug)

结局指标

主要结局

Change From Baseline of American Shoulder and Elbow Surgeons (ASES) Questionnaire at 2 Weeks

时间窗: 2 weeks

The American Shoulder and Elbow Surgeons (ASES) Questionnaire is a self-report questionnaire measuring pain and disability. It is measured from 0 to 100, 0 being completely disabled and 100 being pain free and normal function. The total score is calculated using the following equation: (10-NPRS) x 5 = __ + (5/3) x Cumulative ADL Score

Change From Baseline of Numeric Pain Rating Scale (NPRS) at 2 Weeks

时间窗: 2 weeks

The Numeric Pain Rating Scale (NPRS) is a self-report scale measuring pain. It is measured from 0 to 10, 0 being pain free and 10 being the worse imaginable pain.

Change From Baseline of American Shoulder and Elbow Surgeons (ASES) Questionnaire at 4 Weeks

时间窗: 4 weeks

The American Shoulder and Elbow Surgeons (ASES) Questionnaire is a self-report questionnaire measuring pain and disability. It is measured from 0 to 100, 0 being completely disabled and 100 being pain free and normal function. The total score is calculated using the following equation: (10-NPRS) x 5 = __ + (5/3) x Cumulative ADL Score

Change From Baseline of Numeric Pain Rating Scale (NPRS)at 4 Weeks

时间窗: 4 weeks

The Numeric Pain Rating Scale (NPRS) is a self-report scale measuring pain. It is measured from 0 to 10, 0 being pain free and 10 being the worse imaginable pain.

次要结局

未报告次要终点

研究者

发起方
Sport and Spine Rehab Clinical Research Foundation
申办方类型
Other
责任方
Sponsor

研究点 (1)

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