Eccentric Training and Cryotherapy Vs Eccentric Training and Whole Body Vibration in Achilles Tendinopathy

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.

Study Overview

• Status: Completed
• Conditions: Tendinopathy; Achilles Tendon
• Intervention / Treatment: Other: Cryotherapy and eccentric exercise; Other: Vibration and eccentric exercise

• Study Type: Interventional
• Enrollment (Actual): 132
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain, 28022
    • Universidad Europea

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
NO_INTERVENTION: Control
EXPERIMENTAL: Cryotherapy and eccentric exercise	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)
EXPERIMENTAL: Vibration and eccentric exercise	Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change at Achilles Tendon Cross Sectional Area	Ultrasound diagnosis.	3 months
Change at Achilles Tendon Thickness	Ultrasound diagnosis.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Differences between healthy volunteers and volunteers with Achilles tendinopathy	Ultrasound diagnosis	2 weeks

Collaborators and Investigators

• Sponsor: Universidad Europea de Madrid

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 30, 2017
• Primary Completion (ACTUAL): December 15, 2017
• Study Completion (ACTUAL): January 15, 2018

Study Registration Dates

• First Submitted: January 17, 2017
• First Submitted That Met QC Criteria: January 23, 2017
• First Posted (ESTIMATE): January 24, 2017

Study Record Updates

• Last Update Posted (ACTUAL): February 19, 2018
• Last Update Submitted That Met QC Criteria: February 15, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: Cryotherapy; Whole body vibration; Eccentric exercise
• Additional Relevant MeSH Terms: Wounds and Injuries; Musculoskeletal Diseases; Muscular Diseases; Tendon Injuries; Tendinopathy
• Other Study ID Numbers: UEMadrid-Tendon01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No