Overview

This trial is active, not recruiting.

Conditions tendinopathy, rupture of achilles tendon, chronic disease
Treatments 8° incline shoe, kinesitherapy
Sponsor Nantes University Hospital
Start date December 2014
End date January 2016
Trial size 74 participants
Trial identifier NCT02307708, RC13_0043

Summary

The purpose of the study is to compare the treatment by wearing shoes inclined at kinesitherapy because it is the first treatment offered by primary care physicians in chronic Achilles tendinopathy.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose supportive care
Arm
(Experimental)
The shoe is inclined from front to back and from top to bottom of 8 °. This causes a controlled and an eccentric contraction during the passage. During the walk we will have: In support tardigrade : an ankle dorsiflexion with a stretching the Achilles tendon (eccentric contractions). In support digitigrade: plantar flexion of ankle with a muscle contraction of triceps surae (concentric contraction).
8° incline shoe Wearing inclined shoes
Wearing inclined shoes for 6 weeks, walking 15 minutes (2 times/day). The shoe is inclined from front to back and from top to bottom of 8 °. This causes a controlled and an eccentric contraction during the passage. During the walk we will have: In support tardigrade : an ankle dorsiflexion with a stretching the Achilles tendon (eccentric contractions). In support digitigrade: plantar flexion of ankle with a muscle contraction of triceps surae (concentric contraction).
(Active Comparator)
The patient performs its home therapy and consults his physiotherapist once a week according to the protocol Stanish
kinesitherapy The kinesitherapy for the treatment of tendinopathy
Daily eccentric contraction at home and once per week for 6 weeks with the physiotherapist

Primary Outcomes

Measure
Evolution of the American Orthopaedic Foot and Ankle Score (AOFAS)
time frame: at Day 0 and 12 weeks

Secondary Outcomes

Measure
Evolution of amplitude to the tibio-tarsal
time frame: at 12 weeks
Pain Scores on the Visual Analog Scale
time frame: at 12 weeks

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

Inclusion Criteria: - Age: 18-75 years - Disease: chronic Achilles tendinopathy de novo or recurrent confirmed by ultrasound - Patients having signed the informed consent for the study participation - Patients covered by medical insurance - Patients having no behavioral disorders Exclusion Criteria: - History of rupture of the Achilles tendon (= stage 4) - Antibiotic treatment tendinotoxique (Quinolones, ...) - Inability to walk more than 30 minutes per day. - Haglund Syndrome - Treatment of tendinopathy or being older than six months - Minors - Major trust

Additional Information

Official title Reeducation of Chronic Achilles Tendinopathy by Wearing Shoes Inclined Versus Reeducation by Kinesitherapy
Principal investigator Bertrand Rousseau
Trial information was received from ClinicalTrials.gov and was last updated in December 2014.
Information provided to ClinicalTrials.gov by Nantes University Hospital.