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RECRUITING

NCT05407194

Effect of Collagen/Vitamin C in Jumper's Knee; a RCT

Sponsor: Gelderse Vallei Hospital

View on ClinicalTrials.gov

Summary

Patellar tendinopathy (PT) is a tendon overuse injury with high prevalence rates in elite and recreational athletes. PT sometimes results in a prolonged absence from sport participation, hampering individuals to achieve their desired performance levels and to benefit from the health related effects of sports participation. Many treatment options are used but management of PT remains challenging. Current treatment involves progressive education, load management and tendon loading exercises (PTLE). Recent studies have shown that nutrition can positively affect collagen synthesis in musculoskeletal tissues. A study showed that supplementing 15g of gelatine combined with 50mg of Vitamin C, 1 hour before loading exercises, resulted in an increase in whole body collagen synthesis and increased mechanics and collagen content of human engineered ligaments. However the effectiveness of oral supplementation of hydrolysed collagen in combination with vitamin C in athletes with PT has not been studied in a randomized controlled trial yet. Objective: The primary aim of this RCT is to evaluate whether the use of oral supplementation of hydrolysed collagen/vitamin C in addition to usual care (education, load management and PTLE) is superior to usual care and placebo on VISA-P score after 12, 24 and 52 weeks for athletes with PT. The secondary aim of this RCT is to evaluate whether the use of oral supplementation of hydrolysed collagen/vitamin C in addition to usual care (education, load management and PTLE) is superior to usual care and placebo on other clinical outcome parameters, functional tests and tendon structure after 12 and 24 weeks for athletes with PT.

Official title: Additional Effect of Collagen/Vitamin C in Exercise Treatment for Patellar Tendinopathy (Jumper's Knee); a Randomized Controlled Trial

Key Details

Gender

All

Age Range

16 Years - 40 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2023-04-01

Completion Date

2026-05-01

Last Updated

2024-09-26

Healthy Volunteers

Yes

Conditions

Patellar Tendinopathy

Interventions

DIETARY_SUPPLEMENT

Collagen + vitamin C

Participants take the supplement (or placebo) every day for 24 weeks. On three days per week they perform tendon loading exercises.

Inclusion Criteria: * Age 16 - 40 years old (the chosen age range will minimize chances of other conditions causing anterior knee pain such as osteoarthritis among patients above 40 years and osteochondrotic diseases like Sinding-Larsen-Johansson syndrome and Osgood-Schlatter disease among patients below the age of 16). * History of focal knee pain in patellar tendon or its patellar or tibial insertion in association with training and/or competition. * Current symptom duration of at least 12 weeks. * Sports participation at least once a week for at least one year. * Palpation tenderness to the corresponding painful area on the patellar tendon. * Focal patellar tendon pain during patellar tendon loading with a pain provocation test (single leg decline squat and/or single leg jump squat) * Victorian Institute of Sports Assessment (VISA-P) score \< 80 out of 100 points. * Willingness to take (non-vegetarian) nutritional supplements. Exclusion Criteria: * Known presence of inflammatory joint diseases (e.g. spondylarthropathy, gout or rheumatoid arthritis) or familial hypercholesterolaemia. * Daily use of drugs with a putative effect on the patellar tendon in the preceding year (e.g. fluoroquinolones and statins) * Knee surgery without a full completion of the rehabilitation program in the history of the index knee * Previous patellar tendon rupture of the index knee * Local injection therapy with corticosteroids, other drugs, blood, platelet rich plasma or stem cells in the preceding 12 months * Acute knee injuries, including patellar tendon injuries with an acute onset * Inability to perform the PTLE program * Participation in other concomitant treatment programs * Signs or symptoms of other coexisting knee pathology on physical examination (such as patellofemoral pain syndrome, joint effusion and joint line tenderness) or additional diagnostics when found necessary by the sports physician (Chondral lesion of the patella or trochlea on MRI or prepatellar bursitis on US). * Already using collagen supplementation * Giving blood donation in a period of two months prior to each test day * Being pregnant or wish to become pregnant in the upcoming year * Abuse of hard drugs * An alcohol consumption \>21 units/week (men) or \>14 units/week (women)

Locations (1)

Gelderse Vallei Hospital

Ede, Gelderland, Netherlands