Achilles TendinopathyNCT03515148
Effectiveness of EE With Vibration Versus Cryotherapy in Rectus Abdomini Muscle Thickness and Inter-recti Distance
A study testing Cryotherapy and eccentric exercise and Vibration and eccentric exercise in people with Achilles Tendinopathy and Diastasis Recti, run by Universidad Europea de Madrid at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Achilles Tendinopathy, Diastasis Recti
- What is being tested?
- Cryotherapy and eccentric exercise and Vibration and eccentric exercise
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 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
- No healthy volunteers
- 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)
- Pain in palpation of Achilles, (3/10 VAS)
- Morning Stiffness
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
Show all 14Show fewer
- 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
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
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.
- Conditions
- Achilles Tendinopathy, Diastasis Recti
- Being tested
- Cryotherapy and eccentric exercise, Vibration and eccentric exercise
- Keywords
- Achilles Tendinopathy, Rectus Abominis, Vibration, Cryotherapy, Eccentric Exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cryotherapy and eccentric exerciseProcedure or surgery
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)
Vibration and eccentric exerciseProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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 Receives: Procedure: Vibration and eccentric exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inter-recti distance
Ultrasound diagnosis
Measured: 3 months
Rectus abdominis thickness
Ultrasound diagnosis
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2018
- 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 TendinopathyStudies 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
- 61 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
- Investigators
- Pedro J Martin, Principal investigator, Pejamalla@gmail.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03515148
- Sponsor's protocol ID
- Tendon02
- Status last verified
- May 2018
- First submitted
- 21 Apr 2018
- Last updated
- 8 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03515148
- Acronym / sponsor ID
- Tendon02
- Conditions
- Achilles Tendinopathy, Diastasis Recti
- Keywords
- Achilles Tendinopathy, Rectus Abominis, Vibration, Cryotherapy, Eccentric Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 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
- 3 May 2018 (actual)
- 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 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cryotherapy and eccentric exercise | Experimental | Procedure: Cryotherapy and eccentric exercise12 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) |
| Vibration and eccentric exercise | Experimental | Procedure: Vibration and eccentric exercise12 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 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 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 or surgery | Cryotherapy and eccentric exercise |
| Vibration and eccentric exercise12 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 or surgery | Vibration and eccentric exercise |
Primary outcome
Inter-recti distance
Time frame: 3 months
Ultrasound diagnosis
Rectus abdominis thickness
Time frame: 3 months
Ultrasound diagnosis
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 8 May 2018.
Related trials for Achilles Tendinopathy
Not yet recruitingObservational study
Open Versus Fully Endoscopic Calcaneoplasty With Achilles Tendon Insertional Reconstruction for Haglund Syndrome
Haglund Syndrome, Insertional Achilles Tendinopathy
Recruiting
Single-Row Versus Double-Row Repair for Achilles Insertional Tendinopathy
Achilles Insertional Tendinopathy, Achilles Tendinopathy
Enrolling by invitationObservational study
Achilles Non-SNIS REGENETEN
Complete Mid-portion Achilles Rupture
Not yet recruitingObservational study
Human Tendon Tissue Collection
Tendinopathy, Musculoskeletal Diseases or Conditions
Not yet recruiting
Extracorporeal Shockwave Therapy and Platelet-Rich Plasma for Midportion Achilles Tendinopathy
Achilles Injuries Tendon, Achilles Tendinopathy (AT)
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.
Pedro J Martin principal investigator
Pejamalla@gmail.com
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 Tendinopathy and Diastasis Recti, 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 8 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 8 May 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?
Inter-recti distance (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 8 May 2018.