- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03515148
Effectiveness of EE With Vibration Versus Cryotherapy in Rectus Abdomini Muscle Thickness and Inter-recti Distance
May 2, 2018 updated by: Pedro Javier Martin, Universidad Europea de Madrid
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
61
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Madrid, Spain, 28022
- Universidad Europea
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 63 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
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
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Cryotherapy and eccentric exercise
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)
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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)
|
Experimental: Vibration and eccentric exercise
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
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Inter-recti distance
Time Frame: 3 months
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Ultrasound diagnosis
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3 months
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Rectus abdominis thickness
Time Frame: 3 months
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Ultrasound diagnosis
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3 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Pedro J Martin, Pejamalla@gmail.com
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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
April 21, 2018
First Submitted That Met QC Criteria
April 21, 2018
First Posted (Actual)
May 3, 2018
Study Record Updates
Last Update Posted (Actual)
May 8, 2018
Last Update Submitted That Met QC Criteria
May 2, 2018
Last Verified
May 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Tendon02
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Achilles Tendinopathy
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University of CalgarySport Science Association of Alberta (SSAA)UnknownAchilles Tendinopathy | Achilles Tendon Enthesopathy | Mid-Portion Achilles Tendinopathy | Insertional Achilles Tendinopathy | Non-Insertional Achilles TendinopathyCanada
-
Krankenhaus Barmherzige Schwestern LinzActive, not recruitingAchilles Tendinopathy | Insertional Achilles TendinopathyAustria
-
University of DelawareActive, not recruitingAchilles Tendinopathy | Achillodynia | Achilles Tendon Pain | Achilles Tendonitis | Achilles DegenerationUnited States
-
Guna S.p.aRecruitingTendinopathy | Achilles Tendinopathy | Insertional Achilles Tendinopathy | PeritendinitisItaly
-
Chinese University of Hong KongNot yet recruitingAchilles Tendinopathy | Achilles Tendon RuptureHong Kong
-
Philadelphia College of Osteopathic MedicineRecruitingAchilles Tendinopathy | Achilles Tendon Pain | Achilles Tendonitis | Ankle StrainUnited States
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University of DelawareRecruitingSever's Disease | Achilles Tendinopathy | Insertional Achilles Tendinopathy | Apophysitis; CalcaneusUnited States
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University of Gran RosarioRecruitingTendon Injuries | Achilles Tendinopathy | Achilles Tendon PainArgentina
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Chinese University of Hong KongNot yet recruiting
-
North Park PodiatryRecruiting
Clinical Trials on Cryotherapy and eccentric exercise
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Universidad Europea de MadridCompletedTendinopathy | Achilles TendonSpain
-
Wilfrid Laurier UniversityUnknown
-
Oslo University HospitalUniversity of OsloCompleted
-
University of MalagaUnknownRotator Cuff Tendinopathy
-
Queen Margaret UniversityUnknownTendinopathy | Achilles TendonUnited Kingdom
-
Utah State UniversityNot yet recruitingBlood Flow Restriction
-
New York Institute of TechnologyRecruitingHypermobility SyndromeUnited States
-
Centre Hospitalier Universitaire de BesanconUnknownVentilatory Adaptation to Concentric Versus Eccentric Exercise in Patients With Severe COPD (CONvEX)Chronic Obstructive Pulmonary Disease SevereFrance
-
University Hospital, Clermont-FerrandUnknown
-
Uppsala UniversityThe Swedish Research Council; Uppsala County Council, Sweden; Amersham FoundationCompleted