Exercise Therapy for Patellar Tendinopathy Evaluated With Advanced UTE-MRI
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|ClinicalTrials.gov Identifier: NCT02938143|
Recruitment Status : Active, not recruiting
First Posted : October 19, 2016
Last Update Posted : February 11, 2020
|Condition or disease||Intervention/treatment||Phase|
|Tendinopathy||Procedure: Exercise Procedure: Exercise (usual care)||Not Applicable|
Patellar tendinopathy ('jumper's knee') is a clinical condition of gradually progressive activity-related pain at the insertion of the patellar tendon at the apex patellae. Prolonged repetitive stress of the knee-extensor apparatus can lead to this common overuse tendinopathy in athletes from different sports, resulting in pain and impaired performance in athletes. High prevalence rates have been reported in jumping sports such as volleyball and basketball (45% and 32% in elite athletes, respectively). Symptoms can be long-standing if not treated appropriately in the initial stages. Furthermore, there is currently no strong evidence for second-line treatments such as shockwave therapy and platelet-rich plasma. Therefore, it is important to improve exercise protocols as a first treatment of choice.
Tendinopathy is a widely accepted, generic term that encompasses any abnormal condition of a tendon. Clinical symptoms include activity-related pain associated with tenderness, localized swelling and impaired performance. Histopathologically, tendinopathy is characterized by structural disorganization of the tendon collagen that alters the loading capacity of a specific tendon.
Exercise therapy is considered as the best initial treatment option for tendinopathies as histopathological changes and clinical improvements on pain and function have been demonstrated. Most studies have been conducted using eccentric exercise protocols and early studies showed positive effects, resulting in promoting these isolated painful exercises as standard care. One hypothesis behind the potential beneficial effects of eccentric exercises is that increased load results in increased collagen synthesis and subsequent healing response. However, a recent systematic review demonstrated that the available literature does not support observable structural change as an explanation for the response of eccentric exercises. Furthermore, eccentric exercises may not be effective for reducing pain and improving strength when used in-season and might even increase symptoms in jumping athletes with patellar tendon pathology.
Progressive tendon-loading exercise therapy for patellar tendinopathy constitutes a novel concept in sports medicine. A recent publication advocates a progressive 4-stage criteria-based exercise protocol within the limits of pain, consisting of progressive isometric, isotonic, plyometric, and sport-specific exercises, resulting in a less reactive tendon, immediate decreased pain levels, diminished motor cortex inhibition of the quadriceps muscles, and potential to restore collagen alignment. These new insights are completely conflicting with the painful heavy-load eccentric exercise protocols currently applied as usual care. It is currently unknown which exercise therapy is the best strategy for athletes with patellar tendinopathy, as adequately powered randomized studies are lacking.
Although clinical examination represents the gold standard in the diagnosis of patellar tendinopathy, it is commonplace to perform diagnostic imaging of the patellar tendon to confirm the diagnosis and rule out alternative diagnoses. Furthermore, imaging can be used to estimate response to treatment. This diagnostic imaging work-up usually consists of magnetic resonance imaging (MRI), ultrasound or, occasionally, a combination of both. On "regular" MRI, increased tendon size and visually increased signal intensity within the proximal patellar tendon can be observed in patellar tendinopathy , but altered tendon microstructure is invisible. A novel innovative method to detect tendon abnormalities is the ultrashort echo time (UTE) MRI technique. UTE enables accurate detection of changes in a reactive tendon both visually and in a quantitative manner by measuring T2* relaxation time UTE MRI has also been shown to quantitatively depict changes in tendon microstructure and, therefore, this innovative imaging modality allows in-vivo evaluation of tendon regeneration. It is currently unknown whether quantitative UTE MRI parameters change after exercise treatment, are related to clinical symptoms of patellar tendinopathy, and have prognostic value for exercise treatment response.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||76 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Progressive Tendon-loading Exercise Therapy for Patellar Tendinopathy in Jumping Athletes: A Randomized Controlled Clinical Trial Evaluated With Advanced 3D UTE MR|
|Actual Study Start Date :||January 2017|
|Estimated Primary Completion Date :||January 2021|
|Estimated Study Completion Date :||January 2021|
Experimental: 4-stage criteria-based exercise protocol
a progressive 4-stage criteria-based exercise protocol within the limits of pain
The intervention treatment is a progressive 4-stage criteria-based exercise protocol within the limits of pain, consisting of progressive isometric, isotonic, plyometric, and sport-specific exercises.24 Progression criteria are individualized.
Active Comparator: Heavy-load eccentric exercise protocol
a 12-week painful heavy-load eccentric exercise protocol
Procedure: Exercise (usual care)
The control treatment is a painful heavy-load eccentric exercise program performed twice daily with 3 sets of 15 repetitions for 12 weeks on a 25° decline board. The downward component (eccentric component) will be performed with the symptomatic leg and the upward component (concentric phase) on the asymptomatic leg.
- The change of the validated and disease-specific VISA-P score over 24 weeks [ Time Frame: 24 weeks ]The change of the validated and disease-specific VISA-P score over 24 weeks
- Subjective patient satisfaction [ Time Frame: 3 years ]Subjective patient satisfaction (excellent / good / fair / poor)
- Return to sports [ Time Frame: 3 years ]Return to sports (Return to desired sport on pre-injury level / return to desired sport but on a lower level / return to sports but not desired sport / no return to sports
- Time to return to full training in desired sport [ Time Frame: 3 years ]Time to return to full training in desired sport
- Pain rating on a Visual Analogue Scale (VAS) [ Time Frame: 3 years ]Pain rating on a Visual Analogue Scale (VAS) in which 0 represents no pain, and 100 maximal pain
- Strength (N.kg.m) of the abductors and quadriceps muscles using dynamometry [ Time Frame: 3 years ]Strength (N.kg.m) of the abductors and quadriceps muscles using dynamometry Leg length of the upper extremity will be measured to be able to correct for lever arm.
- Flexibility of the calf muscles using the weight-bearing dorsiflexion lunge tes [ Time Frame: 3 years ]Flexibility of the calf muscles using the weight-bearing dorsiflexion lunge tes
- Compliance to the exercise program (total percentage of prescribed exercises performed). [ Time Frame: 3 years ]Compliance to the exercise program (total percentage of prescribed exercises performed). This will be asked on a weekly basis using a short online questionnaire.
- Training load [ Time Frame: 3 years ]Training load, which is defined as: Total duration of training and match play per week (minutes) multiplied by the experienced intensity of training sessions and games using the modified Borg CR-10 RPE scale.46 This will be asked on a weekly basis using a short online questionnaire.
- MRI: Conventional: maximum anterior-posterior (AP) thickness and signal abnormalities [ Time Frame: 3 years ]Conventional: maximum anterior-posterior (AP) thickness and signal abnormalities (intratendinous, peritendinous).
- MRI: 3D UTE Cones: T2* relaxation time [ Time Frame: 3 years ]3D UTE Cones: T2* relaxation time
- US:· Grey scale: maximum anterior-posterior (AP) thickness, presence of calcification [ Time Frame: 3 years ]Grey scale: maximum anterior-posterior (AP) thickness, presence of calcification
- US: PDU: Doppler signal (neovascularisation score determined with the modified Ohberg Scale). [ Time Frame: 3 years ]PDU: Doppler signal (neovascularisation score determined with the modified Ohberg Scale).
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02938143
|Rotterdam, Zuid Holland, Netherlands, 3015CE|
|Principal Investigator:||Edwin H Oei, Dr||Erasmus Medical Center|
|Principal Investigator:||Robert-Jan de Vos, Dr.||Erasmus Medical Center|
|Principal Investigator:||S Breda, Drs.||Erasmus Medical Center|