Short-term effect of hydrolized collagen (TENDOFORTE [Trademark] P) in the treatment of chronic midportion Achilles tendinopathy: a pilot study
- Conditions
- Chronic midportion Achilles tendinopathyMusculoskeletal - Other muscular and skeletal disordersPhysical Medicine / Rehabilitation - PhysiotherapyDiet and Nutrition - Other diet and nutrition disorders
- Registration Number
- ACTRN12615001035516
- Lead Sponsor
- GELITA Australia Pty Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 20
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
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
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method ltrasonographic Tissue Characterization (UTC)<br>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.<br>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. <br>A composite of these imaging measurements forms the primary outcome<br>[0, 3 months, and 6 months (there is no wash out period between treatment 1 and 2) ]
- Secondary Outcome Measures
Name Time Method 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];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. <br>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]