Plantar FasciitisITUNCT04125264
Intense Therapeutic Ultrasound (ITU) to Treat Plantar Fasciitis
A study testing Intense Therapeutic Ultrasound in people with Plantar Fasciitis and Plantar Fasciitis, Chronic, run by Universidad Complutense de Madrid at 1 site in Spain.
Trial summary
It was previously hypothesized that patients receiving Intense Therapeutic Ultrasound (ITU) in addition to the standard of care would have a more rapid resolution of pain, faster return to activities, and a decrease in intra- and perifascial lesions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Plantar Fasciitis, Plantar Fasciitis, Chronic, Ultrasound Therapy
- What is being tested?
- Intense Therapeutic Ultrasound
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- Oct 2019to Oct 2021
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Both sex patients.
- Plantar fasciitis diagnosis: pain during walking during the first steps in the morning; pain due to palpation of plantar fasciia insertion.
- Chronic pain of at least 6 month.
- Longitudinal thickness of the plantar fasciia more than 4 millimeters.
- No previous surgery in the plantar fasciia.
- No previous application of alternative treatments such us shock waves or injections (last ninety days)
Who cannot join
- Platelet count disorder or anticoagulation therapy.
- Anti-inflammatories usual treatment for the treatment of plantar fasciitis.
- Diabetic foot syndrome.
- Presence of metabolic disease such us: hypertension, hiper or hipothyroidism.
- Pregnancy or breastfeeding.
- Previous treatment with fluoroquinolones antibiotic.
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- Bilateral plantar fasciitis.
- Diagnosed Autoimmune disesase.
- Morphofunctional disorders in the foot and ankle.
- Diagnosed fibromyalgia.
- Heel disestesy.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Diabetic foot Unit Complutense University
Madrid, 28040
Raúl Juan Molines Barroso, Phd, 639059104 ext. +34, rauljmolines@hotmail.com
José Luis Lázaro Martínez, Phd
About this study
Official title: The Application of Intense Therapeutic Ultrasound in Plantar Fasciitis. A Randomized, Non-probabilistic and Superiority Controlled Clinical Trial
It was previously hypothesized that patients receiving Intense Therapeutic Ultrasound (ITU) in addition to the standard of care would have a more rapid resolution of pain, faster return to activities, and a decrease in intra- and perifascial lesions.
Read the detailed description
Intense Therapeutic Ultrasound (ITU) is an established ultrasound-based therapy in which sound waves are concentrated and focused into a well-defined specific area of musculoskeletal tissue. Previous researches hipothesize that the application of ITU improve and accelerate healing in patients with chronic plantar fasciitis.
- Being tested
- Intense Therapeutic Ultrasound
- Medical subject headings
- Fasciitis, Plantar
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intense Therapeutic UltrasoundDevice
Application of 1000 pulses, until 5000 joules (5 joules per pulse), during approximately 15 minutes, with the possibility of 5 minutes rest, depending on the tolerance of the patient.
| Study group | Role | What they receive |
|---|---|---|
| Intense therapeutic Ultrasound | Experimental | During the trial two applications of 1000 pulses each one (day one and day thirty) will be applied. Pulse regulation could be modified from 4 to 5 joules depending the presence or not of pain.
Conservative treatment of plantar fasciitis include: custom made foot orthosis with the same general characteristics plus plantar fasciia and achilles tendon stretching. Receives: Device: Intense Therapeutic Ultrasound |
| Control group | No intervention | Non ITU application. Conservative treatment of plantar fasciitis include: custom made foot orthosis with the same general characteristics plus plantar fasciia and achilles tendon stretching. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain reduction
Use of a Subjective Visual Analogue Scale (SVAS): the outmost left (0 cm) was labelled pain absence and the outmost right (10 cm) was labelled the maximum imagined pain.
Measured: 24 weeks
Plantar fasciia thickness reduction
Longitudinal view of the plantar fasciia with the use of ultrasound probe.
Measured: 24 weeks
Secondary outcomes (5)
Hypoechoic volume area reduction
Longitudinal and transversal view of the hypoechoic area of plantar fasciia with the use of ultrasound probe.
Measured: 24 weeks
Ankle range of motion reduction
Goniometry of the ankle in the extended and flexed position of the knee
Measured: 24 weeks
Time to incorporation to daily live activities
Patients satisfaction scale (6 items)
Measured: 24 weeks
Autonomous gait without pain in the heel
Patients autonomous gait scale (6 items)
Measured: 24 weeks
Improvement of patients satisfaction
Patients satisfaction scale (6 items)
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2019
- Study startOct 2019 (estimated)
- Primary completionOct 2020 (estimated)
- Study completionOct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plantar FasciitisStudies of the same condition, open and under way.
- More trials run by Universidad Complutense de MadridThe sponsor's other registered studies.
- 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
- Model description
- Randomized, Non-probabilistic and Superiority Controlled Clinical Trial.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Complutense de Madrid
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Raúl Juan Molines Barroso, Phd, Universidad Complutense de Madrid
- Investigators
- José Luis Lázaro Martínez, Phd, Principal investigator, Universidad Complutense Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04125264
- Sponsor's protocol ID
- 18/399-R_P
- Acronym
- ITU
- Status last verified
- Oct 2019
- First submitted
- 10 Oct 2019
- Last updated
- 16 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Application of Intense Therapeutic Ultrasound in Plantar Fasciitis. A Randomized, Non-probabilistic and Superiority Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT04125264
- Acronym / sponsor ID
- ITU / 18/399-R_P
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Universidad Complutense de MadridUniversity, hospital or other
- Study start
- Oct 2019 (estimated)
- Primary completion
- Oct 2020 (estimated)
- Study completion
- Oct 2021 (estimated)
- First posted
- 14 Oct 2019 (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.
It was previously hypothesized that patients receiving Intense Therapeutic Ultrasound (ITU) in addition to the standard of care would have a more rapid resolution of pain, faster return to activities, and a decrease in intra- and perifascial lesions.
Detailed description
Intense Therapeutic Ultrasound (ITU) is an established ultrasound-based therapy in which sound waves are concentrated and focused into a well-defined specific area of musculoskeletal tissue. Previous researches hipothesize that the application of ITU improve and accelerate healing in patients with chronic plantar fasciitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized, Non-probabilistic and Superiority Controlled Clinical Trial.
| Arm | Type | Receives |
|---|---|---|
| Intense therapeutic Ultrasound | Experimental | Device: Intense Therapeutic UltrasoundDuring the trial two applications of 1000 pulses each one (day one and day thirty) will be applied. Pulse regulation could be modified from 4 to 5 joules depending the presence or not of pain. Conservative treatment of plantar fasciitis include: custom made foot orthosis with the same general characteristics plus plantar fasciia and achilles tendon stretching. |
| Control group | No intervention | –Non ITU application. Conservative treatment of plantar fasciitis include: custom made foot orthosis with the same general characteristics plus plantar fasciia and achilles tendon stretching. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Both sex patients.
- Plantar fasciitis diagnosis: pain during walking during the first steps in the morning; pain due to palpation of plantar fasciia insertion.
- Chronic pain of at least 6 month.
- Longitudinal thickness of the plantar fasciia more than 4 millimeters.
- No previous surgery in the plantar fasciia.
Key exclusion criteria (11 listed)
- Platelet count disorder or anticoagulation therapy.
- Anti-inflammatories usual treatment for the treatment of plantar fasciitis.
- Diabetic foot syndrome.
- Presence of metabolic disease such us: hypertension, hiper or hipothyroidism.
- Pregnancy or breastfeeding.
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 |
|---|---|---|
| Intense Therapeutic UltrasoundApplication of 1000 pulses, until 5000 joules (5 joules per pulse), during approximately 15 minutes, with the possibility of 5 minutes rest, depending on the tolerance of the patient. | Device | Intense therapeutic Ultrasound |
Primary outcome
Pain reduction
Time frame: 24 weeks
Use of a Subjective Visual Analogue Scale (SVAS): the outmost left (0 cm) was labelled pain absence and the outmost right (10 cm) was labelled the maximum imagined pain.
Plantar fasciia thickness reduction
Time frame: 24 weeks
Longitudinal view of the plantar fasciia with the use of ultrasound probe.
5 secondary outcomes
Hypoechoic volume area reduction
Time frame: 24 weeks
Ankle range of motion reduction
Time frame: 24 weeks
Time to incorporation to daily live activities
Time frame: 24 weeks
Autonomous gait without pain in the heel
Time frame: 24 weeks
Improvement of patients satisfaction
Time frame: 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2019.
- Individual participant dataSharing planned: No
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Hip Muscle Strengthening and Calf Myofascial Release in Females With Chronic Plantar Fasciitis
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F-18 Sodium Fluoride PET/CT-Guided Pain Palliation in Chronic Plantar Fasciitis: A Comparative Study of ¹⁷⁷Lutetium-Corticosteroid-Local Anaesthetic Injection vs Corticosteroid-Local Anaesthetic Injection
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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.
José Luis Lázaro Martínez, Phd principal investigator
Universidad Complutense Madrid
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intense Therapeutic Ultrasound in people with Plantar Fasciitis and Plantar Fasciitis, Chronic, run by Universidad Complutense 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 6 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 16 Oct 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Raúl J. Molines Barroso, Phd (639059104 ext. +34, rauljmolines@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain reduction (time frame: 24 weeks). 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 16 Oct 2019.