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Comparison of two different exercise programs in mid-portion Achilles tendinopathy: a randomized trial.


- candidate number23581
- NTR NumberNTR5638
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR7-jan-2016
- Secondary IDsNL56035.041.15 
- Public TitleComparison of two different exercise programs in mid-portion Achilles tendinopathy: a randomized trial.
- Scientific TitleAlfredson versus Silbernagel exercise therapy in chronic mid-portion Achilles tendinopathy: a randomized controlled trial.
- ACRONYMASET-study
- hypothesisIt is hypothesized that the Silbernagel exercise program yields at least similar results in terms of symptom reduction (VISA-A score and VAS score)compared with the Alfredson eccentric exercise program.
- Healt Condition(s) or Problem(s) studiedAchilles tendinopathy
- Inclusion criteria- Clinical diagnosis of unilateral mid-portion Achilles tendinopathy (Achilles tendon pain and swelling 2-7 cm from calcaneal insertion);
- Duration of symptoms at least three months;
- Age 18-60 years of age;
- Male gender;
- Participating in sport involving Achilles tendon loading (i.e. running and/or jumping);
- Able to comply with both exercise programs.
- Exclusion criteria- Bilateral symptoms;
- Diagnosis of insertional Achilles tendinopathy (insertion of Achilles tendon onto posterior aspect of the calcaneus);
- Washout period of < four weeks from other treatments;
- Corticosteroid injections in the region of the Achilles tendon in the previous 12 months;
- Other lower limb injuries in previous 12 months;
- Previous surgery in the affected limb;
- History of Achilles tendon rupture in affected limb;
- Systemic diseases, such as rheumatoid arthritis and diabetes mellitus.
- mec approval receivedno
- multicenter trialyes
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-mei-2016
- planned closingdate1-mei-2018
- Target number of participants86
- InterventionsTwo different loading programs for the plantar flexor muscle-tendon unit; i.e. isolated eccentric loading according to the Alfredson program, or a combination of concentric and eccemtric loading according to the Silbernagel program.
- Primary outcome- Victorian Institute of Sports Assessment - Achilles (VISA-A) questionnaire
- Visual Analog Scale (VAS) for pain during sports activities
- Secondary outcome- VAS for pain during activities of daily life
- Morning stiffness
- Quality of life (EQ5D, SF-12)
- Perceived recovery
- Jumping height
- Plantar flexor endurance
- Variables related to cost-effectiveness
- TimepointsBaseline, 12 weeks, 6 months, and 12 months.
- Trial web siteNot applicable
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESPhD B.M.A. Huisstede
- CONTACT for SCIENTIFIC QUERIESMSc Bas Habets
- Sponsor/Initiator University Medical Center Utrecht (UMCU), Sport Medisch Centrum Papendal
- Funding
(Source(s) of Monetary or Material Support)
University Medical Center Utrecht (UMCU), Sport Medisch Centrum Papendal
- Publications
- Brief summaryBackground: Mid-portion Achilles tendinopathy (AT) is a common overuse injury of the lower extremity, often challenging for patients and therapists. Exercise therapy (i.e. tendon loading) is considered crucial in conservative management, but the most effective exercise program is unknown. Alfredson’s eccentric program and Silbernagel’s concentric-eccentric program have both shown beneficial results in the treatment of AT, but it is unknown whether any program is superior for use in clinical practice.

Objective: To investigate the difference in effectiveness between the Alfredson eccentric and the Silbernagel concentric-eccentric exercise program on patient-reported function and pain during sports in patients with chronic mid-portion AT after 12 weeks.

Study design: Prospective multicenter single blind randomized controlled trial.

Study population: A total of 86 recreational male athletes (18-60 years of age) with a clinical diagnosis of unilateral Achilles tendinopathy will be included.

Intervention: Two exercise programs will be compared. The first is the Alfredson eccentric exercise program, in which participants perform eccentric heel-drops on their injured leg, twice daily, for three sets of 15 repetitions, and both with a straight and bent knee (i.e. 180 repetitions per day). The other program is the Silbernagel concentric-eccentric program, in which participants perform various 2-legged and 1-legged heel-raising exercises, for three sets of 15 repetitions, but in this program exercises are only performed once daily.

Main study parameters/endpoints: The primary outcome measures for this study will be patient-reported function in daily activities and sport (measured with the Dutch version of the Victorian Institute of Sport Assessment – Achilles questionnaire) and pain during sports activities (measured with a visual analog scale) after 12 weeks.
- Main changes (audit trail)9-jul-2017 -MT:
Target number of participants: 86 instead of 66.

INCLUSION criteria
- Clinical diagnosis of unilateral mid-portion Achilles tendinopathy (Achilles tendon pain and swelling 2-7 cm from calcaneal insertion);
- Duration of symptoms at least three months;
- Age 18-60 years of age;
- Male gender;
- Participating in sport involving Achilles tendon loading (i.e. running and/or jumping);
- Able to comply with both exercise programs.

Replaced by
- Clinical diagnosis of unilateral mid-portion Achilles tendinopathy (Achilles tendon pain and swelling 2-7 cm from calcaneal insertion);
- Duration of symptoms at least three months;
- Age 18-60 years of age;
- Participating in sport involving Achilles tendon loading (i.e. running and/or jumping);
- Able to comply with both exercise programs.
- RECORD7-jan-2016 - 9-jul-2017


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