Continued Activity During Rehabilitation in Patients With Patellar Tendinopathy
追踪信息 | |||
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首次提交日期 ICMJE | October 1, 2018 | ||
首次发布日期e ICMJE | October 3, 2018 | ||
最后更新发布日期 | October 5, 2018 | ||
预计研究开始日期 ICMJE | October 15, 2018 | ||
预计主要完成日期 | October 15, 2020 (主要结果测量的最终数据收集日期) | ||
目前主要观察指标 ICMJE |
Willingness to Participate[ Time Frame: Percentage over initial year of study recruitment ] The percentage of potential participants that are willing to enroll and be randomized to one of the two groups after being informed of the study Drop Out Rate[ Time Frame: Percentage over initial year of study recruitment ] The percentage of participants that drop-out after study randomization. Symptoms[ Time Frame: Change over time with evaluations at baseline, 6-weeks, 12-weeks, 6-months and 1-year ] Victorian Institute of Sport Assessment - Patella questionnaire (VISA-P) Tendon Structure[ Time Frame: Change over time with evaluations at baseline, 6-weeks, 12-weeks, 6-months and 1-year ] Ultrasound imaging of tendon structure Continuous Shear Wave Elastography (cSWE) to measure tendon mechanical properties[ Time Frame: Change over time with evaluations at baseline, 6-weeks, 12-weeks, 6-months and 1-year ] Continuous shear wave elastography (cSWE) will be used to measure shear modulus, viscosity and dynamic shear modulus of the patellar tendon. Muscle-tendon function[ Time Frame: Change over time with evaluations at baseline, 6-weeks, 12-weeks, 6-months and 1-year ] Functional test battery consisting of two jump tests, one muscle strength and activation test. |
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原始主要观察测量 ICMJE | 与当前相同 | ||
目前的二级观察 ICMJE |
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描述性信息 | |||
简略标题 ICMJE | Continued Activity During Rehabilitation in Patients With Patellar Tendinopathy | ||
正式标题 ICMJE | Continued Activity During Rehabilitation in Patients With Patellar Tendinopathy | ||
简要概况 | This pilot study will evaluate the feasibility of pain-guided activity modification during rehabilitation for patellar tendinopathy. The information provided will be utilized to conduct a larger randomized clinical trial to determine if there is a difference in recovery from patellar tendinopathy during rehabilitation between individuals that use pain-guided activity modification and those that halt all painful activities. Recovery from patellar tendinopathy will be assessed using pain ratings, tendon-specific outcome measures, tendon structure, tendon mechanical properties, and muscle function. |
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详细说明 | Patellar tendinopathy is a chronic, degenerative condition of the patellar tendon that results in pain, altered tendon structure, functional impairments, decreased sports performance, and lost playing time. It commonly affects jumping athletes in sports such as volleyball and basketball. The prevalence of patellar tendinopathy is high, with 11.8-14.4% of recreational and 32-45% of elite volleyball and basketball players reporting symptoms. Although many athletes will seek treatment, 27-49% will experience re-injury and over half of those injured will retire from their sport of choice due to recurrent symptoms. Additionally, the absence of symptoms does not ensure full recovery of tendon health and function, which may contribute to the high rates of recurrence. Exercise therapy for the treatment of patellar tendinopathy is supported by the highest level of evidence. However, exercise therapy has been found to be ineffective if the patients continue with full sports participation. On the other hand, it is unclear if it is necessary for athletes to completely halt physical activities while undergoing treatment. Absence from sport due to injury has been associated with increased anxiety, depression, and decreased self-esteem. Therefore, it is of interest to maintain sports participation, as long as it does not interfere with injury recovery. In a randomized controlled trial (RCT) the investigators evaluated if continued running and jumping during treatment with an Achilles tendon-loading strengthening program had an effect on the outcome in patients with Achilles tendinopathy. In this study the investigators found that there were no detrimental effects of being physically active when the level of activity was guided by a pain-monitoring model. However, the impact of pain-guided activity modification has not been investigated in patellar tendinopathy. The proposed pilot study will determine if continued activity, using a pain-monitoring model, is feasible during treatment for patients with patellar tendinopathy. Furthermore, the investigators will evaluate if there is a negative effect on recovery of symptoms, tendon structure and mechanical properties, and functional recovery when adding continued physical activity compared to rest during exercise therapy treatment. To achieve this objective, the investigators will conduct a RCT comparing patients with patellar tendinopathy that are allowed to continue sports participation during treatment, using a pain-monitoring model, to those that are not allowed to participate in activities that cause pain. Aim 1 is to evaluate feasibility by examining compliance and satisfaction with continued sports participation, guided by a pain-monitoring model, compared to refraining from sports participation during treatment. This will provide critical information to determine if a larger randomized clinical trial is feasible and if the study protocol needs to be modified. Aim 2 is to evaluate if there is a difference in change over time in symptoms, tendon structure and mechanical properties, and function between the two interventions. This study will be the first to evaluate continued sports participation, guided by a pain-monitoring model, during rehabilitation in patients with patellar tendinopathy. The results from this study will play a critical role in achieving the long-term research goal of understanding of how to develop tailored treatments for patients with tendon injury. Ultimately this work will inform clinician recommendations regarding activity modification and potentially, limit the negative psychosocial impacts of the injury. | ||
研究类型 ICMJE | Interventional | ||
研究阶段 | N/A | ||
研究设计 ICMJE | 分配: Randomized 干预模型: Parallel Assignment 干预模型描述: Two treatment groups receiving different activity modification instructions. 盲法: Interventional 盲法描述:The study staff responsible for collecting primary and secondary outcomes will be blinded to group allocation. 主要目的: Prevention |
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适用条件 ICMJE | |||
干预项目 ICMJE |
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研究工具 |
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招募信息 | |||
招募状态 ICMJE | Not yet recruiting | ||
预计入组 ICMJE |
30 | ||
原始预计入组 ICMJE | 与当前相同 | ||
预计研究完成日期 | October 15, 2020 | ||
预计主要完成日期 | October 15, 2020 (主要结果测量的最终数据收集日期) | ||
合格标准 ICMJE | Inclusion Criteria: - Diagnosis of patellar tendinopathy Exclusion Criteria: - Injury that limits ability to participate in testing - History of knee surgery within the last 6 months. - Injection, shockwave, tenotomy or Ten-X to the patellar tendon within the last 6 months. | ||
性别 |
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年龄 | 最小年龄:16 Years ,最大年龄:40 Years | ||
接受健康的志愿者 | 没有 | ||
可入组国家 ICMJE | |||
管理信息 | 数据检测委员会 | No | |
研究涉及美国FDA监管的产品 |
研究美国FDA监管的药品: No 研究涉及美国FDA监管的设备产品: No |
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IPD 共享声明 |
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责任方 | , | ||
研究赞助商 ICMJE | University of Delaware | ||
合作者 ICMJE | |||
研究员 ICMJE |
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PRS 账户 | |||
验证日期 | October 2018 | ||
ICMJE 国际医学期刊编辑委员会和 世界卫生组织 ICTRP 要求的元素 |