Short-term effect of hydrolized collagen (TENDOFORTE [Trademark] P) in the treatment of chronic midportion Achilles tendinopathy: a pilot study

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12615001035516
• Date of registration: 06/10/2015
• Prospective Registration: No
• Primary sponsor: GELITA Australia Pty Ltd
• Public title: Short-term effect of hydrolized collagen (TENDOFORTE [Trademark] P) in the treatment of chronic midportion Achilles tendinopathy: a pilot study
• Scientific title: In patients with chronic midportion Achilles tendinopathy, does the short term consumption of hydrolized collagen enhance recovery in comparison to placebo?
• Date of first enrolment: 02/10/2015
• Target sample size: 20
• Recruitment status: Completed
• URL: https://anzctr.org.au/ACTRN12615001035516.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Crossover;Type of endpoint: Efficacy;
• Phase: Not Applicable

Countries of recruitment

Australia

Contacts

• Name: Dr Stephan Praet

• Name: Dr Stephan Praet

Key inclusion & exclusion criteria

Inclusion criteria: Clinical diagnosis "chronic midportion Achilles tendinopathy" based on the following criteria:
1. Pain on palpation 2-7 cm above the insertion of the Achilles tendon (“midportion”)
2. Complaints from the Achilles tendon for at least 2 months

Exclusion criteria: 1. Clinical suspicion of insertional disorders (pain at the site of the insertion of the Achilles tendon on the calcaneum)
2. Clinical suspicion of an Achilles tendon rupture (Thompson test abnormal and palpable "gap")
3. Clinical suspicion of plantar flexor tenosynovitis (posteromedial pain when the toes are plantar flexed against resistance)
4. Clinical suspicion of n.suralis pathology (sensitive disorder in the area of the sural nerve)
5. Clinical suspicion of peroneal subluxation (visible luxation of the mm. Peroneï spot in combination with localized pain)
6. Suspicion of internal disorders: spondylarthropathy, gout, hyperlipidemia, Rheumatoid Arthritis and sarcoidosis. This will be determined both clinically and with blood (CRP, BSE, uric acid and total cholesterol).
7. Condition that prevents the patients from executing an active exercise programme
8. Patient that has already performed eccentric exercises, according to the schedule of Alfredson et al (12 weeks)
9. Patient that has already received any type of injection in the previous months
10. Patient does not wish, for whatever reason, to undergo one of the two treatments
11. Known presence of a pregnancy
12. Condition of the Achilles tendon caused by medications (arising in relation to moment of intake), such as quinolones and statins


Age minimum: 18 Years
Age maximum: 55 Years
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Physical Medicine / Rehabilitation - Physiotherapy

Chronic midportion Achilles tendinopathy;
Chronic midportion Achilles tendinopathy

Diet and Nutrition - Other diet and nutrition disorders

Musculoskeletal - Other muscular and skeletal disorders

Intervention(s)

12 weeks supplementation of TENDOFORTE [Trademark] P (containing 5g of highly bioactive collagen peptides) in drink form in combination with eccentric exercise therapy.

Participants will be asked to consume the treatment twice per day with each dose containing 2.5g of highly bioactive collagen peptides or placebo. Participants will consume either TENDOFORTE or placebo for 12 weeks followed by another 12 weeks of the opposite treatment (placebo or TENDOFORTE) without any washout period in between. Participants will be asked to bring back unused packets of the investigational product.

The eccentric calf muscle exercises will be performed with straight knee and with bent knee as described by Alfredson et al. Participants will be instructed to perform 90 repetition, twice a day, for a duration of 2 times 12 weeks without any washout period in between. Participants will be asked to begin the eccentric exercise program on the first day without a period of gradual increase. Participants will be instructed that these exercises commonly cause pain and that they should ignore this pain. They will also be instructed to increase the load when the exercises could be performed without any discomfort. Increasing load will be done using a backpack, with added weights, or a weight machine. When pain during or after exercises is unbearable or disabling, the patient will be advised to contact the clinician. The patients will be informed that they could expect muscle soreness, besides experiencing pain. All patients will be instructed to avoid weight-bearing sporting activities for the first 4 weeks. After 4 weeks, gradual return to sports activities will be encouraged if the pain allowed.

In a one-on-one instructional session, a physiotherapist will explain and de

Primary Outcome(s)

Ultrasonographic Tissue Characterization (UTC)
"Real-time” consecutive transverse ultrasound images will be taken of the Achillles tendon allowing the tendon to be evaluated in 3 "planes of view" and the stability of the ultrasound pattern can be quantified.
Measurements made by the UTC that are carried out: 1. maximum AP diameter 2. distance of the lesion from insertion 3. lesion type (I-IV) 4. percentage intact collagen bundles.
A composite of these imaging measurements forms the primary outcome
[0, 3 months, and 6 months (there is no wash out period between treatment 1 and 2) ]

Secondary Outcome(s)

Power Doppler ultrasound (PDU): using PDU, the thickness of the Achilles tendon and the degree of neovascularisation (Grade 0-4 +) can be determined.[0, 3 months and 6 months]

Bicomponent analysis of Achilles tendon volumes using ultra-short echo spins (UTE) on a 3T MRI after 3 and 6 months.
UTE analysis is currently a non-validated highly novel MRI analysis tool and will depend on the collaboration and intellectual property of a third party (Philips Health Care).[0, 3 months and 6 months]

VISA-A questionnaire: this is a validated instrument specifically designed to evaluate the clinical severity for patients with chronic Achilles tendinopathy. It is an easily self-administered questionnaire that evaluates symptoms and their effect on physical activity.[0, 3 months and 6 months]

2D Contrast enhanced Ultrasonography (using DEFINITY [registered trademark] microbubbles) to monitor subtle but clinically relevant changes in microvascular status of the Achilles tendon.[0, 3 months and 6 months]

Secondary ID(s)

Nil

Source(s) of Monetary Support

GELITA Australia Pty Ltd

Secondary Sponsor(s)

Australian Institute of Sport

Ethics review

Status: Approved
Approval date:
Contact:

Australian Institute of Sport Human Research Ethics Committee