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Effectiveness of EE With Vibration Versus Cryotherapy in Rectus Abdomini Muscle Thickness and Inter-recti Distance

Primary Purpose

Achilles Tendinopathy, Diastasis Recti

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 Tendinopathy focused on measuring Achilles Tendinopathy, Rectus Abominis, Vibration, Cryotherapy, Eccentric Exercise

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

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 Type

Experimental

Experimental

Arm Label

Cryotherapy and eccentric exercise

Vibration and eccentric exercise

Arm Description

12 weeks, 5 days/week, once a day, 2 exercise, 3 sets/execise, 15 repetition/set of eccentric exercise of foot plantar flexors First exercise with knee in extension, second exercise with knee in flexion. Previously subjects should cold their leg in ice water during sexteen minutes at a temperature of 8ºC (+/-2ºC)

12 weeks, 5 days/week, once a day, 2 exercise, 3 sets/execise, 15 repetition/set of eccentric 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. Vibrations parameters: Frequency: 35Hz, Amplitude: 4 milimeters, Force: 3,9G

Outcomes

Primary Outcome Measures

Inter-recti distance
Ultrasound diagnosis
Rectus abdominis thickness
Ultrasound diagnosis

Secondary Outcome Measures

Full Information

First Posted
April 21, 2018
Last Updated
May 2, 2018
Sponsor
Universidad Europea de Madrid
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1. Study Identification

Unique Protocol Identification Number
NCT03515148
Brief Title
Effectiveness of EE With Vibration Versus Cryotherapy in Rectus Abdomini Muscle Thickness and Inter-recti Distance
Official Title
Effectiveness of Eccentric Exercise With a Vibration Program Versus Cryotherapy in Rectus Abdomini Muscle Thickness and Inter-recti Distance in Patients With Chronic Mid Portion Achilles Tendinopathy: A Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 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 determinate de efectiveness of eccentric exercise combined with vibration or cryotherapy in achilles tendinopathy and its effects on the anterior rectus abdominis muscle. The investigators hypothesis is the combined eccentric exercise with vibration get better results than cryotherapy with eccentric exercise in rectus abdominis muscle parameters.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Achilles Tendinopathy, Diastasis Recti
Keywords
Achilles Tendinopathy, Rectus Abominis, Vibration, Cryotherapy, Eccentric Exercise

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Cryotherapy and eccentric exercise
Arm Type
Experimental
Arm Description
12 weeks, 5 days/week, once a day, 2 exercise, 3 sets/execise, 15 repetition/set of eccentric exercise of foot plantar flexors First exercise with knee in extension, second exercise with knee in flexion. Previously subjects should cold their leg in ice water during sexteen minutes at a temperature of 8ºC (+/-2ºC)
Arm Title
Vibration and eccentric exercise
Arm Type
Experimental
Arm Description
12 weeks, 5 days/week, once a day, 2 exercise, 3 sets/execise, 15 repetition/set of eccentric 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. Vibrations parameters: Frequency: 35Hz, Amplitude: 4 milimeters, Force: 3,9G
Intervention Type
Procedure
Intervention Name(s)
Cryotherapy and eccentric exercise
Intervention Description
12 weeks, 5 days/week, once a day, 2 exercise, 3 sets/execise, 15 repetition/set of eccentric exercise of foot plantar flexors First exercise with knee in extension, second exercise with knee in flexion. Previously subjects should cold their leg in ice water during sexteen minutes at a temperature of 8ºC (+/-2ºC)
Intervention Type
Procedure
Intervention Name(s)
Vibration and eccentric exercise
Intervention Description
12 weeks, 5 days/week, once a day, 2 exercise, 3 sets/execise, 15 repetition/set of eccentric 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. Vibrations parameters: Frequency: 35Hz, Amplitude: 4 milimeters, Force: 3,9G
Primary Outcome Measure Information:
Title
Inter-recti distance
Description
Ultrasound diagnosis
Time Frame
3 months
Title
Rectus abdominis thickness
Description
Ultrasound diagnosis
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pedro J Martin
Organizational Affiliation
Pejamalla@gmail.com
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universidad Europea
City
Madrid
ZIP/Postal Code
28022
Country
Spain

12. IPD Sharing Statement

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Effectiveness of EE With Vibration Versus Cryotherapy in Rectus Abdomini Muscle Thickness and Inter-recti Distance

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