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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04125264
Other study ID # 18/399-R_P
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date October 2019
Est. completion date October 2021

Study information

Verified date October 2019
Source Universidad Complutense de Madrid
Contact Raúl J. Molines Barroso, Phd
Phone 639059104
Email rauljmolines@hotmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 30
Est. completion date October 2021
Est. primary completion date October 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- 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)

Exclusion Criteria:

- 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.

- Bilateral plantar fasciitis.

- Diagnosed Autoimmune disesase.

- Morphofunctional disorders in the foot and ankle.

- Diagnosed fibromyalgia.

- Heel disestesy.

Study Design


Intervention

Device:
Intense Therapeutic Ultrasound
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.

Locations

Country Name City State
Spain Diabetic foot Unit Complutense University Madrid

Sponsors (1)

Lead Sponsor Collaborator
Universidad Complutense de Madrid

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 24 weeks
Primary Plantar fasciia thickness reduction Longitudinal view of the plantar fasciia with the use of ultrasound probe. 24 weeks
Secondary Hypoechoic volume area reduction Longitudinal and transversal view of the hypoechoic area of plantar fasciia with the use of ultrasound probe. 24 weeks
Secondary Ankle range of motion reduction Goniometry of the ankle in the extended and flexed position of the knee 24 weeks
Secondary Time to incorporation to daily live activities Patients satisfaction scale (6 items) 24 weeks
Secondary Autonomous gait without pain in the heel Patients autonomous gait scale (6 items) 24 weeks
Secondary Improvement of patients satisfaction Patients satisfaction scale (6 items) 24 weeks
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