Patellar Tendinopathy - The Role of Restitution Time in Exercise- Based Treatment: A Randomized Controlled Trial (the TEREX Trial)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 52
- 试验地点
- 2
- 主要终点
- Patient perception VISA-P
研究概览
简要总结
The purpose of the present project is to investigate if the restitution time from loading in an exercise-based 12 weeks rehabilitation regime for patellar tendinopathy influences the clinical outcome, tendon structure and function.
The investigators hypothesize that greater restitution from loading (1 exercise day per week) will yield a greater positive clinical outcome, and tissue structure and function in patients with patellar tendinopathy compared to less restitution (3 exercise days per week), when impact activities are restricted in both groups.
详细描述
This study is designed as a prospective, randomized, controlled, open label, superiority trial with a two-group parallel design and primary endpoint after 12 weeks. The study has two phases; The first phase includes the main trial in which a 12-week intervention period will be undertaken to test the hypotheses in patients with chronic patellar tendinopathy (symptoms > 3 months).
At 12 weeks, a smaller group of patients (responding and not-responding to the 12-week intervention period) will be offered to participate in sub-study 1. In this explorative cross-sectional study, the feasibility of mapping brain structure, function and metabolism using Magnetic resonance imaging (MRI) with Blood Oxygenation Level Dependent (BOLD) imaging technique in chronic patellar tendinopathy patients will be assessed.
The second phase in the main study includes the follow-up from 12 week to the secondary endpoint at 52 weeks after baseline. During this period the participants will be monitored via questionnaires for treatment satisfaction and improvements at 4-week intervals. What treatment and the duration of treatment patients will receive in this phase is based on the concept of personalized medicine. We expect the majority of patient to continue in the group with loading-based intervention. A smaller group of the 52 patients from the main study is expected to be included in sub-study two.
Sub study two is designed as an observational cohort study. In this sub study, patients reporting no self-evaluated improvement after 12 weeks of loading-based treatment will be asked to be part of a group receiving corticosteroid injection treatment followed by continued exercise-based treatment and avoidance of impact loading. The cohort will further include patients that after week 20, 24, 28, 32, 36 and 40 respond that they have not achieved their Patient Acceptable Symptom State (PASS).
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Sports active men and women.
- •Age (18-60) years old.
- •BMI (18.5-30)
- •Understand and read Danish
- •Uni- or bilateral patellar tendinopathy
- •Symptom onset >90 days ago
排除标准
- •Patellar tendinopathy longer than 24 months
- •Previous surgery in the knee on the ipsilateral side.
- •Corticosteroid injection in the patellar tendon on the ipsilateral side within the last 6 months.
- •Any confounding diagnosis to the knee joint
- •Known arthritis
- •Known diabetes
- •Inability to follow rehabilitation or complete follow-ups
- •Enrolled in a resistance based-rehabilitation program for the affected patellar tendon within the previous three month
- •Have a work were it is not feasible to avoid pain provoking tasks
- •Extra criteria sub-study one
- •Inclusion criteria:
- •Five patients from the main study, rating "improved" and "not improved" respectively, will be invited to participate in sub-study one.
- •Exclusion criteria:
- •Claustrophobia
- •Pregnancy
- •Breastfeeding
- •Extra criteria sub-study two:
- •Inclusion criteria:
- •Patients from the main study, that rate themselves 'not improved' in symptoms after 12 week.
- •Patients who have not achieved Patient Acceptable Symptom State (PASS) after week 20, 24, 28, 32, 36 and 40, will be invited to participate in sub- study two.
- •Exclusion criteria:
- •Pregnancy
- •Breastfeeding
- •Previously had an allergic reaction for steroid (Depomedrol).
- •Previously had an allergic reaction for local anesthesia treatment.
研究组 & 干预措施
Short restitution group (SR)
Resistance training for knee extensors three training session per week.
干预措施: Resistance training for knee extensors (Other)
Extended restitution group (ER)
Resistance training for knee extensors on training session per week (greater restitution from loading).
干预措施: Resistance training for knee extensors (Other)
结局指标
主要结局
Patient perception VISA-P
时间窗: Change from baseline at week 12
Change in Victorian Institute of Sports Assessment - patella (VISA-P) total score. The VISA-P asses symptoms, function and the ability to participate in sport. It consists of 8 questions, with a maximum score of 100 indicating the person is asymptomatic and fully per-forming and lower scores indicating more symptoms and limitations of function and activity.
次要结局
- Self-reported pain (NRS) - Preferred sport(Change from baseline at week 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52.)
- Self-reported pain (NRS) - Daily activities(Change from baseline at week 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52.)
- Care-seeking behavior(Week 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52.)
- Ultrasonography - tendon microvascularisation(Change from baseline at week 12 and 52.)
- Sports types(Week 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52.)
- Self-reported pain (NRS) - Rest(Change from baseline at week 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52.)
- Self-reported improvement (GROC)(Change from baseline at week 12, 16 and 52.)
- Sports participation(Week 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52.)
- Counter movement Jump height(Change from baseline at week 12 and 52.)
- Patient perception VISA-P truncated(Change from baseline at week 12, 16 and 52)
- Treatment received(Week 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52.)
- The single-leg decline squat (SLDS) will be used to assess pain during function(Change from baseline at week 12 and 52.)
- Muscle strength(Change from baseline at week 12 and 52.)
- Ultrasonography - tendon neovascularization(Change from baseline at week 12 and 52.)
- Sports intensity(Week 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52.)
- Self-reported satisfaction (PASS)(Week 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52)
- Ultrasonography - tendon thickness(Change from baseline at week 12 and 52.)
- Patient perception VISA-P secondary(Change from baseline at week 16 and 52)
研究者
Anne-Sofie Agergaard
Postdoc
Bispebjerg Hospital