NCT03515148

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
61

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 30, 2017

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2018

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 21, 2018

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 3, 2018

Completed
Last Updated

May 8, 2018

Status Verified

May 1, 2018

Enrollment Period

11 months

First QC Date

April 21, 2018

Last Update Submit

May 2, 2018

Conditions

Achilles TendinopathyDiastasis Recti

Keywords

Achilles TendinopathyRectus AbominisVibrationCryotherapyEccentric Exercise

Outcome Measures

Primary Outcomes (2)

  • Inter-recti distance

    Ultrasound diagnosis

    3 months

  • Rectus abdominis thickness

    Ultrasound diagnosis

    3 months

Study Arms (2)

Cryotherapy and eccentric exercise

EXPERIMENTAL

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

Vibration and eccentric exercise

EXPERIMENTAL

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

Interventions

Cryotherapy and eccentric exercisePROCEDURE

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)

Cryotherapy and eccentric exercise
Vibration and eccentric exercisePROCEDURE

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

Vibration and eccentric exercise

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad Europea

Madrid, 28022, Spain

Location

MeSH Terms

Interventions

CryotherapyVibration

Intervention Hierarchy (Ancestors)

TherapeuticsMechanical PhenomenaPhysical Phenomena

Study Officials

  • Pedro J Martin

    Pejamalla@gmail.com

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 21, 2018

First Posted

May 3, 2018

Study Start

January 30, 2017

Primary Completion

December 15, 2017

Study Completion

January 15, 2018

Last Updated

May 8, 2018

Record last verified: 2018-05

Locations

ES(1)