Tendinopathy
Conditions
Brief summary
Tendon injuries represent a significant problem in elite athletes. Therefore, prevention and effective treatment of tendon overload injury/tendinopathy is important. Among different treatment options, heavy-slow loading based rehabilitation is considered among the most efficient treatments in athletes. In this study, we will investigate if supplementation with hydrolyzed collagen in combination with a heavy-slow loading based 12 weeks rehabilitation regime can improve treatment of tendon overload injury/tendinopathy. The investigators will examine elite athletes with overload injury/tendinopathy with regards to symptoms (pain, function), tendon morphology (ultrasonography), and vascularization (Doppler US). The investigators hypothesize that collagen supplementation can have an improving effect on tendon pain and function. Thus, the investigation will show if a rehabilitation regime of collagen supplementation combined with heavy-slow mechanical loading can improve tendon healing compared to mechanical loading alone.
Detailed description
Randomized placebo-controlled intervention study with follow-up after one month
Interventions
DIETARY_SUPPLEMENTHydrolyzed collagen
Hydrolyzed collagen supplementation twice daily
Heavy slow resistance training 3 times weekly
DIETARY_SUPPLEMENTPlacebo
Placebo supplementation twice daily
Sponsors
Team Denmark
University of Aarhus
Bispebjerg Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
* Elite athletes * 18-40 years old * Exercise related tendon pain on one or both legs * Soreness during physical examination of tendon upon palpation * Uni- or bilateral tendinopathy symptoms \> 3 months
Exclusion criteria
* Previous tendon surgery * Diabetes * Arthritis * Corticosteroid injection for tendinopathy within the last 3 months * Any form of tendon injection within the last 3 months * Smoking
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximal tendon pain during the past week at preferred sporting activity | Baseline-12 weeks | Change from baseline - 12 weeks using the Numerical Rating Scale (NRS; 0= no pain, 10 = worst imaginable pain) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Self-reported activity level of sporting activities (hours/week) | Baseline, 6 and 12 weeks + 6 month follow-up | Participants will self-report how many hours a week they are performing sporting activities: We will monitor to see if they decrease, maintain or increase hours per week of sporting activity |
| Single-leg decline squat (SLDS) test | Baseline - 12 weeks | A reliable patellar tendon pain provocation test, will be used to assess pain during function using the Numerical Rating Scale (NRS; 0= no pain, 10 = worst imaginable pain) |
| Jump test | Baseline - 12 weeks | A reliable Achilles/Plantaris tendon pain provocation test, will be used to assess pain during function using the Numerical Rating Scale (NRS; 0= no pain, 10 = worst imaginable pain) |
| Treatment satisfaction | 12 weeks | Participants will be asked after the intervention period whether they were satisfied or not with the treatment (dichotomal : Yes vs. No) |
| Collagen supplement | Baseline - 12 weeks + 6 month follow-up | Participants will be asked on a weekly basis if taken their collagen supplement : Questionnaire (dichotomal : Yes vs. No) |
| Adverse events (e.g. allergies, gastro-intestinal side effects) related to supplement ingestion | Baseline - 12 weeks + 6 month follow-up | Participants will self-report adverse events during intervention period and at 6 month follow-up |
| Maximal tendon pain during the past week at preferred sporting activity | Baseline, 6 weeks + 6 month follow-up | Change from baseline - 6 weeks + 1 month follow-up using the Numerical Rating Scale (NRS; 0= no pain, 10 = worst imaginable pain) |
| Change from baseline Victorian Institute of Sports Assessment - Patella/Achilles Questionnaire (VISA-P/A) at 12 wks | Baseline, 6 and 12 weeks + 6 month follow-up | Patient reported outcome regarding symptoms, function and the ability to participate in sports |
| Change from baseline Foot function index - Plantaris questionnaire at 12 wks | Baseline, 6 and 12 weeks + 6 month follow-up | Patient reported outcome regarding symptoms, function and the ability to participate in sports |
| Tendon Doppler activity using Ultrasonography power Doppler | Baseline - 12 weeks | Using Ultrasonography, we will measure Doppler activity within the affected tendon and use the program ImageJ for the analysis |
| Tendon thickness measured using Ultrasonography | Baseline - 12 weeks | — |
| Pain rating on Numeric Rating Scale (NRS; 0 = no pain; 10 = worst imaginable pain) during training. | Baseline, 6 and 12 weeks + 6 month follow-up | — |
| Return-to-sport activities | Baseline - 12 weeks + 6 month follow-up | Participants will self-report Return-to-sport activities during intervention period and at 6 month follow-up (dichotomal : Yes vs. No) |
Countries
Denmark
Outcome results
None listed