Acupuncture for Insertional Achilles Tendinopathy in the Primary Care Setting: a Randomized Comparative Effectiveness Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 38
- 试验地点
- 4
- 主要终点
- Change in pain over time as measured by the Victorian Institute of Sports Assessment - Achilles Questionnaire (VISA-A)
研究概览
简要总结
The purpose of this study is to compare acupuncture plus a prescribed home exercise program versus a prescribed home exercise program alone to determine which has better outcomes at improving pain relief and physical function in adult patients with insertional Achilles tendinopathy.
The investigators want to compare a combination of two standard of care treatments (acupuncture plus a prescribed home exercise program) versus a single standard of care treatment (a prescribed home exercise program) to determine which has better outcomes with improving pain relief and physical function in patients with insertional Achilles tendinopathy. The investigators hypothesize that there will be a significant improvement in pain and functional outcomes, both acutely and over time, in the acupuncture plus a prescribed home exercise program group versus the group performing a prescribed home exercise program alone. The investigators will measure Achilles pain relief and physical function immediately prior to treatment (baseline), immediately after the initial treatment at day 1, 2 weeks, 4 weeks, 6 weeks, and 12 weeks using the Victorian Institute of Sports Assessment - Achilles Questionnaire (VISA-A). After 3 months, patients with continuing pain in the non-acupuncture arm will be given the option to crossover to the acupuncture arm of the study for an additional 12 weeks of treatment with the subject's concurrence.
详细描述
Screening Visit (research-related):
- Obtain and document signed Informed Consent document and HIPAA Authorization.
- Review past medical history in Armed Forces Health Longitudinal Technology Application (AHLTA) to verify the inclusion/exclusion criteria including previous encounter, vital signs review, co-morbidities, demographics, and problems list.
- Record: Date of birth, age, gender, race, ethnicity, DoD ID number, name of standard of care medications (over-the-counter and prescription), current email address (to be used for scheduling), height (in inches), weight (in pounds),history of prior injury to the injured leg, and note any prior acupuncture received for Achilles tendinopathy.
- If the subject is an active duty member, the investigators will ask: Have you or are you currently on a fitness restriction for Achilles tendinopathy.
If so, what are/were the dates of the restriction?
• There are several standard of care treatments for Achilles tendinopathy which include physical therapy as well as a prescribed home exercise program. The investigators will standardize what patients in this study are receiving by having all subjects follow a standard home exercise program defined as the Insertional Achilles Tendinopathy Eccentric Training Protocol and have them discontinue any formal physical therapy or other therapies when entering this study. Regular physical activity such as exercise is allowed.
Randomization: Subjects will be randomized into 1 of 2 research treatment groups using block randomization with repeated measures:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
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
- •** THIS STUDY IS BEING CONDUCTED AT A MILITARY INSTALLATION. YOU MUST HAVE MILITARY INSURANCE IN ORDER TO PARTICIPATE IN THIS STUDY **
- •Inclusion Criteria:
- •Male and female DoD beneficiaries, age 18 years or older
- •diagnosed with Achilles tendinopathy OR patients meeting criteria of pain 2cm or less from the insertion to the Achilles tendon on the calcaneus.
- •Patients must have had pain for greater than 8 weeks and a VISA-A score less than 60.
排除标准
- •Active cellulitis over the area of needle insertion.
结局指标
主要结局
Change in pain over time as measured by the Victorian Institute of Sports Assessment - Achilles Questionnaire (VISA-A)
时间窗: the first visit, 2 weeks, 4 weeks, 6 weeks, and 12 weeks
Change in pain over time as measured by the Victorian Institute of Sports Assessment - Achilles Questionnaire (VISA-A). The VISA-A is measured as a score out of 100, where a lower score indicates a worse outcome.
次要结局
未报告次要终点