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Progressive Tendon-loading exercise therapy for patellar tendinopathy in jumping athletes: A randomized controlled clinical trial evaluated with advanced 3D UTE MRI

Progressive Tendon-loading exercise therapy for patellar tendinopathy in jumping athletes: A randomized controlled clinical trial evaluated with advanced 3D UTE MRI - Exercise therapy for patellar tendinopathy evaluated with advanced UTE-MRI

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON53044
Enrollment
101
Registered
2016-10-10
Start date
2017-01-09
Completion date
Unknown
Last updated
2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Jumper's knee

Interventions

None listed

Sponsors

Erasmus MC, Universitair Medisch Centrum Rotterdam
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Age 18-35 years old - 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 tendon - VISA-P score

Exclusion criteria

Exclusion criteria: - 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

Design outcomes

Primary

MeasureTime frame
The primary outcome measure is the change in Victorian Institute of Sports Assessment - Patella (VISA-P) score. The VISA-P score is a simple, validated and reliable instrument for measuring the severity of patellar tendinopathy and is sensitive to small changes in symptoms. It was specifically designed for patellar tendinopathy, rating pain, symptoms, simple test of function and the ability to participate in tendon-loading sports .

Secondary

MeasureTime frame
Secondary, we will explore baseline characteristics (personal characteristics, additional questionnaires and results of functional tests) that can aid in predicting the prognosis for these patients. For the secondary imaging outcome measures, we will measure the change over time of the parameters between both treatment groups (treatment response), correlate the imaging parameters with the clinical symptoms and determine the prognostic value of the baseline imaging parameters on the progression of clinical symptoms. The following measurements will be performed: MRI: - Conventional: maximum anterior-posterior (AP) thickness and signal abnormalities (intratendinous, peritendinous). - 3D UTE Cones: T2* relaxation time Ultrasonography: - Grey scale: maximum anterior-posterior (AP) thickness, presence of calcifications. - PDU: Doppler signal (neovascularisation score determined with the modified Ohberg Scale). - SWE: semi-quantitative assessment with SWE color maps, mean and maximum tissue rigidity (kPa) and mean and maximum shear wave speed (m/s). These outcome measurements will be compared to the results obtained in healthy athletes in order to investigate the diagnostic presentation of patellar tendinopathy on shear-wave elastography (SWE). - Accuracy: using 5-point likert scale by 3 experts (1: very inaccurate / misleading; 2: inaccurate; 3:somewhat accurate; 4: accurate; 5: very accurate) - Comprehensiveness: using 5-point likert scale by 3 experts (1: very incomprehensive; 2: incomprehensive; 3:somewhat incomprehensive; 4: comprehensive; 5: very comprehensive) - Readability: Flesch-Kincaid Grade Level (FKGL): a validated readability formula: 0.39*(total words/total sentences)*+*11.8*(total syllables/total words)***15.59. lower score represents *easy to read* and higher score represents most difficult to read. - Understandability and actionably: The Patient Education Materials Assessment Tool (PAMET). Score from 0% (low) to 100% (high)

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)