Additional effect of hydrolysed collagen/vitamin C in exercise treatment for Patellar Tendinopathy (Jumper*s knee); a randomized controlled trial

Recruiting

Conditions: or Jumpersknee
Patellar Tendinopathy
10043237

Registration Number: NL-OMON52228

Lead Sponsor: Ziekenhuisvoorzieningen Gelderse Vallei

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 76

Inclusion Criteria

- Signed informed consent.
- Age 16 - 40 years old
- 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 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.
- Willing to take (non-vegetarian) nutritional supplements.
- Willing and able to perform the PTLE program.

Exclusion Criteria

- Known presence of inflammatory joint diseases (e.g. spondylarthropathy, gout
or rheumatoid arthritis) or familial hypercholesterolaemia.
- 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).
- Daily use of drugs with a putative effect on the patellar tendon in the
preceding year (e.g. fluoroquinolones and statins).
- Having had a patellar tendon surgery.
- Having had a knee surgery without full recovery.
- 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 or patellar tendon injuries (other than PT).
- Participation in other concomitant treatment programs.
- Participation in other research projects during participation of the JUMPFOOD
study.
- Already using (hydrolysed) 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.
- Alcohol consumption for men >21 units/week and >4/day; for women >14
units/week and >3/day.
- Abuse of hard drugs.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary outcome measure is the change over time in the Dutch version of the<br /><br>VISA-P score. This simple, validated, reliable and injury-specific<br /><br>questionnaire assesses the severity of patellar tendinopathy and is sensitive<br /><br>to small changes in symptoms. It is specifically designed for patellar<br /><br>tendinopathy, assessing pain, symptoms, simple function test and ability to<br /><br>participate in tendon-loading sports [1]. A VISA-P score of 100 indicates no<br /><br>pain, maximum function and maximum ability to participate in sports. The score<br /><br>decreases with increasing severity of PT symptoms. The VISA-P questionnaire<br /><br>will be administered at baseline and after 24 weeks of follow-up. The primary<br /><br>outcome measure is the difference between intervention and placebo in<br /><br>difference score between t=24 and t=0.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary outcomes will include: Pain during functional tests, advanced imaging<br /><br>methods and tendon structure and stiffness measurements (ultrasound, UTC,<br /><br>Myoton), blood levels of amino acids and inflammatory markers measured in<br /><br>blood, and dietary habits, that will all be measured at baseline, at 12 weeks<br /><br>and at 24 weeks of follow-up. In addition, data on the compliance with the<br /><br>exercise program and supplement intake, training and competition load will be<br /><br>collected weekly using an online questionnaire.</p><br>