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Trial registered on ANZCTR


Registration number
ACTRN12615001035516
Ethics application status
Approved
Date submitted
11/09/2015
Date registered
6/10/2015
Date last updated
16/08/2017
Type of registration
Retrospectively registered

Titles & IDs
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?
Secondary ID [1] 287436 0
Nil
Universal Trial Number (UTN)
U1111-1174-1366
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic midportion Achilles tendinopathy 296152 0
Condition category
Condition code
Musculoskeletal 296430 296430 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 296431 296431 0 0
Physiotherapy
Diet and Nutrition 296432 296432 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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 demonstrate the exercise programme and participants will also be shown a video of the exercises. Furthermore, the participants will be asked to perform a series of supervised eccentric drops, until the technique is correct.

In order to monitor adherence to the intervention, a research assistant will contact participants through e-mail on a weekly basis and ask them to fill out the number of successful eccentric exercises each day of the week. If the participant does not reply to this e-mail, he/she will be contacted by phone.

After 4, 12 and 24 weeks a face-to-face appointment with a physiotherapist will be scheduled to discuss the progress and check whether the correct technique is still being used.
Intervention code [1] 292806 0
Treatment: Other
Intervention code [2] 292925 0
Rehabilitation
Comparator / control treatment
12 weeks supplementation of Placebo (maltodextrose) drink
Control group
Placebo

Outcomes
Primary outcome [1] 296072 0
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
Timepoint [1] 296072 0
0, 3 months, and 6 months (there is no wash out period between treatment 1 and 2)
Secondary outcome [1] 317434 0
2D Contrast enhanced Ultrasonography (using DEFINITY [registered trademark] microbubbles) to monitor subtle but clinically relevant changes in microvascular status of the Achilles tendon.
Timepoint [1] 317434 0
0, 3 months and 6 months
Secondary outcome [2] 317435 0
Power Doppler ultrasound (PDU): using PDU, the thickness of the Achilles tendon and the degree of neovascularisation (Grade 0-4 +) can be determined.
Timepoint [2] 317435 0
0, 3 months and 6 months
Secondary outcome [3] 317436 0
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).
Timepoint [3] 317436 0
0, 3 months and 6 months
Secondary outcome [4] 317437 0
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.
Timepoint [4] 317437 0
0, 3 months and 6 months

Eligibility
Key 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
Minimum age
18 Years
Maximum age
55 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW

Funding & Sponsors
Funding source category [1] 292011 0
Commercial sector/Industry
Name [1] 292011 0
GELITA Australia Pty Ltd
Address [1] 292011 0
50 Flood Road Josephville QLD 4285
Country [1] 292011 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
GELITA Australia Pty Ltd
Address
50 Flood Road Josephville QLD 4285
Country
Australia
Secondary sponsor category [1] 290680 0
Government body
Name [1] 290680 0
Australian Institute of Sport
Address [1] 290680 0
Leverrier St
BRUCE ACT 2617
Country [1] 290680 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293500 0
Australian Institute of Sport Human Research Ethics Committee
Ethics committee address [1] 293500 0
Leverrier St
BRUCE ACT 2617
Ethics committee country [1] 293500 0
Australia
Date submitted for ethics approval [1] 293500 0
Approval date [1] 293500 0
23/06/2015
Ethics approval number [1] 293500 0
EC002299

Summary
Brief summary
The aim of this pilot research project is to perform a case control study with a cross-over design to explore the potential clinical benefits of 2 times 12 weeks (twice daily) supplementation of TENDOFORTE [Trademark] P (containing 2.5g of highly bioactive collagen peptides) or PLACEBO in chronic midportion Achilles tendinopathy patients as an add-on therapy to 24 weeks of eccentric exercise therapy.
To improve our understanding of the in vivo working mechanism of this nutraceutical, we aim to investigate the ultrastructural and microvascular changes of the Achilles tendon using contrast enhanced ultrasonography, ultrasonographic tissue characterization as well as bicomponent analysis of Achilles tendon volumes ultrashort echo spin (UTE) on a 3T MRI.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 60166 0
Dr Stephan Praet
Address 60166 0
Australian Institute of Sport
Leverrier St
BRUCE ACT 2617
Country 60166 0
Australia
Phone 60166 0
+61262141578
Fax 60166 0
Email 60166 0
stephan.praet@ausport.gov.au
Contact person for public queries
Name 60167 0
Dr Stephan Praet
Address 60167 0
Australian Institute of Sport
Leverrier St
BRUCE ACT 2617
Country 60167 0
Australia
Phone 60167 0
+61262141578
Fax 60167 0
Email 60167 0
stephan.praet@ausport.gov.au
Contact person for scientific queries
Name 60168 0
Dr Stephan Praet
Address 60168 0
Australian Institute of Sport
Leverrier St
BRUCE ACT 2617
Country 60168 0
Australia
Phone 60168 0
+61262141578
Fax 60168 0
Email 60168 0
stephan.praet@ausport.gov.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary