Achilles TendonNCT03029910
Eccentric Training and Cryotherapy Vs Eccentric Training and Whole Body Vibration in Achilles Tendinopathy
A study testing Cryotherapy and eccentric exercise and Vibration and eccentric exercise in people with Achilles Tendon and Tendinopathy, run by Universidad Europea de Madrid at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Achilles Tendon, Tendinopathy
- What is being tested?
- Cryotherapy and eccentric exercise and Vibration and eccentric exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 1 siteSpain
- Study dates
- 30 Jan 2017to 15 Jan 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
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- Pain in palpation of Achilles, (3/10 VAS)
- Morning Stiffness
- Sports people
- Negative initial ultrasound diagnosis
- No syntomp of achilles tendinophaty
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Achilles Tendon, Tendinopathy
- Being tested
- Cryotherapy and eccentric exercise, Vibration and eccentric exercise
- Keywords
- Eccentric exercise, Whole body vibration, Cryotherapy
- Medical subject headings
- Tendinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cryotherapy and eccentric exerciseOther
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)
Vibration and eccentric exerciseOther
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
| Study group | Role | What they receive |
|---|---|---|
| Cryotherapy and eccentric exercise | Experimental | Not described Receives: Other: Cryotherapy and eccentric exercise |
| Vibration and eccentric exercise | Experimental | Not described Receives: Other: Vibration and eccentric exercise |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change at Achilles Tendon Cross Sectional Area
Ultrasound diagnosis.
Measured: 3 months
Change at Achilles Tendon Thickness
Ultrasound diagnosis.
Measured: 3 months
Secondary outcomes (1)
Differences between healthy volunteers and volunteers with Achilles tendinopathy
Ultrasound diagnosis
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2017 (estimated)
- Study start30 Jan 2017
- Primary completion15 Dec 2017
- Study completion15 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Achilles TendonStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Europea de Madrid
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pedro Javier Martin, Universidad Europea de Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03029910
- Sponsor's protocol ID
- UEMadrid-Tendon01
- Status last verified
- Feb 2018
- First submitted
- 17 Jan 2017
- Last updated
- 19 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Eccentric Training and Cryotherapy Vs Eccentric Training and Whole Body Vibration in Achilles Tendinopathy
- ClinicalTrials.gov ID
- NCT03029910
- Acronym / sponsor ID
- UEMadrid-Tendon01
- Conditions
- Achilles Tendon, Tendinopathy
- Keywords
- Eccentric exercise, Whole body vibration, Cryotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Universidad Europea de MadridUniversity, hospital or other
- Study start
- 30 Jan 2017 (actual)
- Primary completion
- 15 Dec 2017 (actual)
- Study completion
- 15 Jan 2018 (actual)
- First posted
- 24 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cryotherapy and eccentric exercise | Experimental | Other: Cryotherapy and eccentric exercise |
| Vibration and eccentric exercise | Experimental | Other: Vibration and eccentric exercise |
| Control | No intervention | – |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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)
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cryotherapy and eccentric exercise12 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) | Other | Cryotherapy and eccentric exercise |
| Vibration and eccentric exercise12 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 | Other | Vibration and eccentric exercise |
Primary outcome
Change at Achilles Tendon Cross Sectional Area
Time frame: 3 months
Ultrasound diagnosis.
Change at Achilles Tendon Thickness
Time frame: 3 months
Ultrasound diagnosis.
1 secondary outcome
Differences between healthy volunteers and volunteers with Achilles tendinopathy
Time frame: 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cryotherapy and eccentric exercise and Vibration and eccentric exercise in people with Achilles Tendon and Tendinopathy, run by Universidad Europea de Madrid at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change at Achilles Tendon Cross Sectional Area (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2018; AzTrials last refreshed its copy on 29 Oct 2026.