Exercise Therapy for Patellar Tendinopathy Evaluated With Advanced UTE-MRI

NCT02938143 | Unknown

• 1 other identifier: UTE MRI
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

Patellar tendinopathy is a frequent overuse injury that causes pain and impaired performance in jumping athletes. Exercise therapy is considered the best initial treatment option for tendinopathies as clinical improvements in pain and function have been demonstrated. Although painful eccentric exercise protocols have been promoted as standard care based on positive results in early studies, a recent systematic review demonstrated that these are not associated with improved tendon structure and are ineffective when applied in-season. Progressive tendon-loading exercise therapy for patellar tendinopathy constitutes a novel concept in sports medicine. A recent study advocates a progressive 4-stage criteria-based exercise protocol as it results in a less reactive tendon and ability to restore collagen alignment. This protocol consists of progressive isometric, isotonic, plyometric, and sport-specific exercises. Isometric exercises have been shown to reduce pain and decrease motor cortex inhibition of the quadriceps. This approach would enable jumping athletes to resume sports within the limits of pain, with improved muscle function, and sufficient tendon structure re-organization. The diagnostic imaging work-up of patellar tendinopathy typically consists of ultrasound, magnetic resonance imaging (MRI), or a combination of both. Ultrashort echo time (UTE) MRI is an advanced MRI technique, which enables assessment of tissues with short T2-time, such as tendon, the structure of which is invisible on regular MRI. UTE has been shown to quantitatively depict changes in tendon microstructure and therefore 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, have prognostic value for exercise treatment response, and offer additional value over ultrasound

Conditions

Tendinopathy

Keywords

Jumpers knee; Patellar Tendinopathy; Jumping Athletes; UTE MRI; Exercise Therapy; NBA

Outcome Measures

Primary Outcomes (1)

• The change of the validated and disease-specific VISA-P score over 24 weeks

  The change of the validated and disease-specific VISA-P score over 24 weeks

  24 weeks

Secondary Outcomes (10)

• Subjective patient satisfaction

  3 years

• Return to sports

  3 years

• Time to return to full training in desired sport

  3 years

• Pain rating on a Visual Analogue Scale (VAS)

  3 years

• Strength (N.kg.m) of the abductors and quadriceps muscles using dynamometry

  3 years

Other Outcomes (2)

• US:· Grey scale: maximum anterior-posterior (AP) thickness, presence of calcification

  3 years

• US: PDU: Doppler signal (neovascularisation score determined with the modified Ohberg Scale).

  3 years

Study Arms (2)

4-stage criteria-based exercise protocol

EXPERIMENTAL

a progressive 4-stage criteria-based exercise protocol within the limits of pain

Procedure: Exercise

Heavy-load eccentric exercise protocol

ACTIVE COMPARATOR

a 12-week painful heavy-load eccentric exercise protocol

Procedure: Exercise (usual care)

Interventions

Exercise PROCEDURE

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.

4-stage criteria-based exercise protocol

Exercise (usual care) PROCEDURE

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.

Heavy-load eccentric exercise protocol

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age 18-35 years old (the chosen age range will minimize chances of other conditions causing anterior knee pain such as osteoarthritis and osteochondrotic diseases like Sinding-Larsen-Johansson syndrome and Osgood-Schlatter disease) History of knee pain in patellar tendon or its patellar or tibial insertion in association with training and competition Playing sports for at least 3 times a week Palpation tenderness to the corresponding painful area On ultrasound, there needs to be a fusiform tendon thickening and/or decreased tendons structure and/or increased Doppler signal within the patellar tendon27 VISA-P score \< 80/100 points

You may not qualify if:

• Known presence of inflammatory joint diseases (e.g. spondylarthropathy, gout or rheumatoid arthritis) or familial hypercholesterolaemia.
• Contraindications for MRI (pregnancy, metallic implants, etc.) Daily use of drugs with a putative effect on the patellar tendon in the preceding year (e.g. fluoroqinolones and statins) Knee surgery in the history of the index knee Previous patellar tendon rupture of the index knee Local injection therapy with corticosteroids in the preceding 12 months Daily exercise therapy with a minimum duration of 4 weeks in total in the preceding 12 months Acute knee or patellar tendon injuries Inability to perform an exercise program Participation in other concomitant treatment programs Signs or symptoms of other coexisting knee pathology on physical examination (such as joint effusion and joint line tenderness) or additional diagnostics (Chondral lesion of the patella or trochlea on MRI or prepatellar bursitis on US).

Sponsors & Collaborators

• Erasmus Medical Center: lead

Study Sites (1)

ErasmusMC

Rotterdam, South Holland, 3015CE, Netherlands

Location

Related Publications (1)

• Deng J, Breda SJ, Eygendaal D, Oei EH, de Vos RJ. Association Between Physical Tests and Patients-Reported Outcomes in Athletes Performing Exercise Therapy for Patellar Tendinopathy: A Secondary Analysis of the JUMPER Study. Am J Sports Med. 2023 Nov;51(13):3523-3532. doi: 10.1177/03635465231200241. Epub 2023 Oct 10.

  PMID: 37815096 DERIVED

MeSH Terms

Conditions

Tendinopathy

Interventions

Exercise

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Tendon Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: dr

Study Record Dates

• First Submitted: October 3, 2016
• First Posted: October 19, 2016
• Study Start: January 1, 2017
• Primary Completion: January 1, 2024
• Study Completion: January 1, 2024
• Last Updated: March 23, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)