Effect of Collagen/Vitamin C in Jumper's Knee; a RCT
ConditionPatellar Tendinopathy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age16-40
SponsorGelderse Vallei Hospital
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Collagen + vitamin C
Dietary supplementParticipants take the supplement (or placebo) every day for 24 weeks. On three days per week they perform tendon loading exercises.
Treatment groups
76 Participants
are divided into 2 treatment groupsGroup A: Supplement + progressive tendon loading therapyExperimental treatment 1 intervention
Group B: Placebo + progressive tendon loading therapyPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
VISA-P Score
The primary outcome measure will be the change in the Dutch version of the VISA-P score. This simple, validated, reliable and injury-specific questionnaire scores 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 \[1\]. A VISA-P score of 100 indicates no pain, maximum function and maximum ability to play sports. The score decreases with increasing severity of symptoms of PT. The VISA-P questionnaire will be self-administered at baseline, and after 6, 12, 18, 24 and 52 weeks follow-up
Time frame
after 6 weeks follow-up2
VISA-P Score
The primary outcome measure will be the change in the Dutch version of the VISA-P score. This simple, validated, reliable and injury-specific questionnaire scores 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 \[1\]. A VISA-P score of 100 indicates no pain, maximum function and maximum ability to play sports. The score decreases with increasing severity of symptoms of PT. The VISA-P questionnaire will be self-administered at baseline, and after 6, 12, 18, 24 and 52 weeks follow-up
Time frame
after 12 weeks follow-up3
VISA-P Score
The primary outcome measure will be the change in the Dutch version of the VISA-P score. This simple, validated, reliable and injury-specific questionnaire scores 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 \[1\]. A VISA-P score of 100 indicates no pain, maximum function and maximum ability to play sports. The score decreases with increasing severity of symptoms of PT. The VISA-P questionnaire will be self-administered at baseline, and after 6, 12, 18, 24 and 52 weeks follow-up
Time frame
after 18 weeks follow-up4
VISA-P Score
The primary outcome measure will be the change in the Dutch version of the VISA-P score. This simple, validated, reliable and injury-specific questionnaire scores 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 \[1\]. A VISA-P score of 100 indicates no pain, maximum function and maximum ability to play sports. The score decreases with increasing severity of symptoms of PT. The VISA-P questionnaire will be self-administered at baseline, and after 6, 12, 18, 24 and 52 weeks follow-up
Time frame
after 24 weeks follow-upSecondary outcomes
1
Pain during functional tests
During several functional tests, pain will be measured on a visual analogue scale, with 0 meaning no pain and 10 meaning unbearable pain, at baseline, 12 weeks and 24 weeks of follow-up.
Time frame
after 12 weeks follow-up2
Pain during functional tests
During several functional tests, pain will be measured on a visual analogue scale, with 0 meaning no pain and 10 meaning unbearable pain, at baseline, 12 weeks and 24 weeks of follow-up.
Time frame
after 24 weeks follow-up3
Imaging methods
Several imaging methods will be performed to identify the physiological parameter tendon structure shown in percentages healthy and damaged cells, at baseline, 12 weeks and 24 weeks of follow-up.
Time frame
after 12 weeks follow-up4
Imaging methods
Several imaging methods will be performed to identify the physiological parameter tendon structure shown in percentages healthy and damaged cells, at baseline, 12 weeks and 24 weeks of follow-up.
Time frame
after 24 weeks follow-upSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov