None listed
Conditions
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.
Interventions
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 betwe
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.
Sponsors
GELITA Australia Pty Ltd
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Healthy volunteers
No
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
Outcome results
None listed