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

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ClinicalTrials.gov Identifier: NCT03515148
Recruitment Status : Completed
First Posted : May 3, 2018
Last Update Posted : May 8, 2018
Sponsor:
Information provided by (Responsible Party):
Pedro Javier Martin, Universidad Europea de Madrid

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.


Condition or disease Intervention/treatment Phase
Achilles Tendinopathy Diastasis Recti Procedure: Cryotherapy and eccentric exercise Procedure: Vibration and eccentric exercise Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 61 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : January 30, 2017
Actual Primary Completion Date : December 15, 2017
Actual Study Completion Date : January 15, 2018

Resource links provided by the National Library of Medicine


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)
Procedure: 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)

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
Procedure: 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




Primary Outcome Measures :
  1. Inter-recti distance [ Time Frame: 3 months ]
    Ultrasound diagnosis

  2. Rectus abdominis thickness [ Time Frame: 3 months ]
    Ultrasound diagnosis



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03515148


Locations
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Spain
Universidad Europea
Madrid, Spain, 28022
Sponsors and Collaborators
Universidad Europea de Madrid
Investigators
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Principal Investigator: Pedro J Martin Pejamalla@gmail.com

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Responsible Party: Pedro Javier Martin, Principal Investigator, Universidad Europea de Madrid
ClinicalTrials.gov Identifier: NCT03515148     History of Changes
Other Study ID Numbers: Tendon02
First Posted: May 3, 2018    Key Record Dates
Last Update Posted: May 8, 2018
Last Verified: May 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Pedro Javier Martin, Universidad Europea de Madrid:
Achilles Tendinopathy
Rectus Abominis
Vibration
Cryotherapy
Eccentric Exercise
Additional relevant MeSH terms:
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Tendinopathy
Muscular Diseases
Musculoskeletal Diseases
Tendon Injuries
Wounds and Injuries