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

Status: Recruiting
Location: See location...
Intervention Type: Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 16
Maximum Age: 40
Healthy Volunteers: t
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• 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.

Locations
Other Locations
Netherlands
Gelderse Vallei Hospital
RECRUITING
Ede
Time Frame
Start Date: 2023-04-01
Estimated Completion Date: 2026-05-01
Participants
Target number of participants: 76
Treatments
Experimental: Supplement + progressive tendon loading therapy
The intervention consists of a nutritional supplement with 10g hydrolysed collagen and 40 mg vitamin C, in comparison to a placebo supplement consisting of maltodextrin. All participants in both groups will receive education, load management advices and a criteria-based PTLE consisting of 4 stages within the limits of pain during 24-weeks. This (training) intervention has recently been proven to be superior to eccentric training. Participants will be randomly assigned to receive either the nutritional supplement collagen/vitamin C (intervention) or a placebo supplement.
Placebo_comparator: Placebo + progressive tendon loading therapy
The placebo consists of maltodextrin. In comparison the intervention consists of a nutritional supplement with 10g hydrolysed collagen and 40 mg vitamin C. All participants in both groups will receive education, load management advices and a criteria-based PTLE consisting of 4 stages within the limits of pain during 24-weeks. This (training) intervention has recently been proven to be superior to eccentric training. Participants will be randomly assigned to receive either the nutritional supplement collagen/vitamin C (intervention) or a placebo supplement.
Related Therapeutic Areas
Sponsors
Leads: Gelderse Vallei Hospital

This content was sourced from clinicaltrials.gov