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临床试验/NCT03694730
NCT03694730已完成不适用

Continued Activity During Rehabilitation in Patients With Patellar Tendinopathy

University of Delaware2 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2018年3月11日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
15
试验地点
2
主要终点
Willingness to Participate

研究概览

简要总结

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.

详细描述

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
16 Years 至 40 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Physically active individuals with a diagnosis of patellar tendinopathy

排除标准

  • 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.

结局指标

主要结局

Willingness to Participate

时间窗: 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

Tendon Structure

时间窗: Change over time with evaluations at baseline, 6-weeks, and 12-weeks

Ultrasound imaging of tendon structure

Continuous Shear Wave Elastography (cSWE) to measure tendon mechanical properties

时间窗: Change over time with evaluations at baseline, 6-weeks, and 12-weeks

Continuous shear wave elastography (cSWE) will be used to measure shear modulus, viscosity and dynamic shear modulus of the patellar tendon.

Drop Out Rate

时间窗: Percentage over initial year of study recruitment

The percentage of participants that drop-out after study randomization.

Symptoms

时间窗: Change over time with evaluations at baseline, 6-weeks, and 12-weeks

Victorian Institute of Sport Assessment - Patella questionnaire (VISA-P)

Muscle-tendon function

时间窗: Change over time with evaluations at baseline, 6-weeks, and 12-weeks

Functional test battery consisting of two jump tests, one muscle strength and activation test.

次要结局

  • Knee Injury and Osteoarthritis Outcome Score - Quality of Life subscale (KOOS-QOL)(Change over time with evaluations at baseline, 6-weeks, and 12-weeks)
  • Pain Catastrophizing Scale (PCS)(Change over time with evaluations at baseline, 6-weeks, and 12-weeks)
  • Depression, Anxiety and Stress Scale (DASS-21)(Change over time with evaluations at baseline, 6-weeks, and 12-weeks)
  • Adverse Events(Number over first year of study recruitment)
  • Tampa Scale of Kinesiophobia (TSK)(Change over time with evaluations at baseline, 6-weeks, and 12-weeks)
  • Compliance with Activity Modification(Average compliance rate for each group over first year of study recruitment)
  • Numeric Pain Rating Scale (NPRS)(Change over time with evaluations at baseline, 6-weeks, and 12-weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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