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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03029910
Other study ID # UEMadrid-Tendon01
Secondary ID
Status Completed
Phase N/A
First received January 17, 2017
Last updated February 15, 2018
Start date January 30, 2017
Est. completion date January 15, 2018

Study information

Verified date February 2018
Source Universidad Europea de Madrid
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine the effectiveness of eccentric exercise combined with vibration or cryotherapy in Achilles tendon pathology.

The investigators hypothesis is that the combined eccentric exercise is better than the results presented by the exclusive eccentric exercise.

This intervention differs from the classic studies in that we maintain the intensity throughout the treatment.


Recruitment information / eligibility

Status Completed
Enrollment 132
Est. completion date January 15, 2018
Est. primary completion date December 15, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- Sports people

- Positive initial ultrasound diagnosis

- Presence of degenerative changes at achilles mid portion

- Chronic Achilles tendon pain, (3/10 VAS)

- Pain when walking or running of Achilles tendon, (3/10 VAS)

- Pain in load in plantar flexion of Achilles tendon, 3/10 VAS)

- Pain in palpation of Achilles, (3/10 VAS)

- Morning Stiffness

Inclusion Criteria Healthy pople:

- Sports people

- Negative initial ultrasound diagnosis

- No syntomp of achilles tendinophaty

Exclusion Criteria:

- Receive physical, orthotic or physiotherapeutic treatment

- Asociated low back pain, ankle/knee/hip injury that may affect the study

- Previous injury or surgery of Achilles tendon.

- Pathologies that may limit the joint of ankle

- Pregnancy

- Obesity

- Patients with diabetes and/or other endocrine or metabolic pathologies or neurologic pathologies

- Patients diagnosed with cardiovascular disease

- Subjets diagnosed with familiar hypercholesterolemia and/or presence of xanthomas or with hyperuricemia

- Patients who have received renal transplantation

- Subjects who have suffered retinal detachment

- Subjects who have received oral contraceptives, statins, corticoids or hormone replacement therapy in the last six months

- Subjects who have received treatment wiht fluoroquinolones in the last two years

- Subjects who have received treatment with AINE's in the last four weeks

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Cryotherapy and eccentric exercise
12 weeks, 5 days/week, once a day, 2 exercises, 3 sets/exercise, 15 repetition/set. Of excentric exercise of foot plantar flexors. First exercise with knee in extension. Second exercise with knee in flexion. Previously subjects should cool their leg in ice water during sixteen minutes at a temperature of 8ºC (+/-2ºC)
Vibration and eccentric exercise
12 weeks, 5 days/week, once a day, 2 exercises, 3 sets/exercise, 15 repetition/set. Of excentric exercise of foot plantar flexors. First exercise with knee in extension. Second exercise with knee in flexion. During the exercise subjects will be subjected to vibration. Vibration parameters: Frequency: 35Hz, Amplitude: 4 millimeters, Force: 3,9G

Locations

Country Name City State
Spain Universidad Europea Madrid

Sponsors (1)

Lead Sponsor Collaborator
Universidad Europea de Madrid

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change at Achilles Tendon Cross Sectional Area Ultrasound diagnosis. 3 months
Primary Change at Achilles Tendon Thickness Ultrasound diagnosis. 3 months
Secondary Differences between healthy volunteers and volunteers with Achilles tendinopathy Ultrasound diagnosis 2 weeks
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