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

Primary Purpose

Achilles Tendon, Tendinopathy

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Cryotherapy and eccentric exercise
Vibration and eccentric exercise
Sponsored by
Universidad Europea de Madrid
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Achilles Tendon focused on measuring Eccentric exercise, Whole body vibration, Cryotherapy

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Universidad Europea

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Cryotherapy and eccentric exercise

Vibration and eccentric exercise

Control

Arm Description

Outcomes

Primary Outcome Measures

Change at Achilles Tendon Cross Sectional Area
Ultrasound diagnosis.
Change at Achilles Tendon Thickness
Ultrasound diagnosis.

Secondary Outcome Measures

Differences between healthy volunteers and volunteers with Achilles tendinopathy
Ultrasound diagnosis

Full Information

First Posted
January 17, 2017
Last Updated
February 15, 2018
Sponsor
Universidad Europea de Madrid
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1. Study Identification

Unique Protocol Identification Number
NCT03029910
Brief Title
Eccentric Training and Cryotherapy Vs Eccentric Training and Whole Body Vibration in Achilles Tendinopathy
Official Title
Eccentric Training and Cryotherapy Vs Eccentric Training and Whole Body Vibration in Achilles Tendinopathy
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
January 30, 2017 (Actual)
Primary Completion Date
December 15, 2017 (Actual)
Study Completion Date
January 15, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad Europea de Madrid

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Achilles Tendon, Tendinopathy
Keywords
Eccentric exercise, Whole body vibration, Cryotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
132 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cryotherapy and eccentric exercise
Arm Type
Experimental
Arm Title
Vibration and eccentric exercise
Arm Type
Experimental
Arm Title
Control
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
Cryotherapy and eccentric exercise
Intervention Description
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)
Intervention Type
Other
Intervention Name(s)
Vibration and eccentric exercise
Intervention Description
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
Primary Outcome Measure Information:
Title
Change at Achilles Tendon Cross Sectional Area
Description
Ultrasound diagnosis.
Time Frame
3 months
Title
Change at Achilles Tendon Thickness
Description
Ultrasound diagnosis.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Differences between healthy volunteers and volunteers with Achilles tendinopathy
Description
Ultrasound diagnosis
Time Frame
2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Universidad Europea
City
Madrid
ZIP/Postal Code
28022
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No

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

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