Effect of Collagen Supplementation on Tendinopathy

Tendinopathy Clinical Trial

Official title:

Effect of Collagen Supplementation on Tendinopathy in Elite Athletes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04578418
• Other study ID #: H-16019857
• Status: Recruiting
• Phase: N/A
• Start date: September 16, 2020
• Est. completion date: June 1, 2023

Study information

• Verified date: January 2021
• Source: Bispebjerg Hospital
• Contact: Kasper Dideriksen, PhD
• Phone: +4524251989
• Email: kasperjuel[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Randomized placebo-controlled intervention study with follow-up after one month

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 32
• Est. completion date: June 1, 2023
• Est. primary completion date: January 1, 2023
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Tendinopathy

Intervention

Dietary Supplement:
• Hydrolyzed collagen
Hydrolyzed collagen supplementation twice daily

Other:
• Heavy slow resistance training
Heavy slow resistance training 3 times weekly

Dietary Supplement:
• Placebo
Placebo supplementation twice daily

Locations

Country	Name	City	State
Denmark	Department of Physical and Occupational Therapy/Institute of Sports Medicine Copenhagen, Bispebjerg Hospital	Copenhagen NV

Sponsors (2)

Lead Sponsor	Collaborator
Bispebjerg Hospital	Team Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximal tendon pain during the past week at preferred sporting activity	Change from baseline - 12 weeks using the Numerical Rating Scale (NRS; 0= no pain, 10 = worst imaginable pain)	Baseline-12 weeks
Secondary	Maximal tendon pain during the past week at preferred sporting activity	Change from baseline - 6 weeks + 1 month follow-up using the Numerical Rating Scale (NRS; 0= no pain, 10 = worst imaginable pain)	Baseline, 6 weeks + 6 month follow-up
Secondary	Self-reported activity level of sporting activities (hours/week)	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	Baseline, 6 and 12 weeks + 6 month follow-up
Secondary	Single-leg decline squat (SLDS) test	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)	Baseline - 12 weeks
Secondary	Jump test	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)	Baseline - 12 weeks
Secondary	Treatment satisfaction	Participants will be asked after the intervention period whether they were satisfied or not with the treatment (dichotom : Yes vs. No)	12 weeks
Secondary	Collagen supplement	Participants will be asked on a weekly basis if taken their collagen supplement : Questionnaire (dichotom : Yes vs. No)	Baseline - 12 weeks + 6 month follow-up
Secondary	Adverse events (e.g. allergies, gastro-intestinal side effects) related to supplement ingestion	Participants will self-report adverse events during intervention period and at 6 month follow-up	Baseline - 12 weeks + 6 month follow-up
Secondary	Return-to-sport activities	Participants will self-report Return-to-sport activities during intervention period and at 6 month follow-up (dichotom : Yes vs. No)	Baseline - 12 weeks + 6 month follow-up
Secondary	Change from baseline Victorian Institute of Sports Assessment - Patella/Achilles Questionnaire (VISA-P/A) at 12 wks	Patient reported outcome regarding symptoms, function and the ability to participate in sports	Baseline, 6 and 12 weeks + 6 month follow-up
Secondary	Change from baseline Foot function index - Plantaris questionnaire at 12 wks	Patient reported outcome regarding symptoms, function and the ability to participate in sports	Baseline, 6 and 12 weeks + 6 month follow-up
Secondary	Tendon Doppler activity using Ultrasonography power Doppler	Using Ultrasonography, we will measure Doppler activity within the affected tendon and use ImageJ for the analysis	Baseline - 12 weeks
Secondary	Tendon thickness measured using Ultrasonography		Baseline - 12 weeks
Secondary	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