Intense Therapeutic Ultrasound (ITU) to Treat Plantar Fasciitis

Plantar Fasciitis Clinical Trial

— ITU  

Official title:

The Application of Intense Therapeutic Ultrasound in Plantar Fasciitis. A Randomized, Non-probabilistic and Superiority Controlled Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04125264
• Other study ID #: 18/399-R_P
• Status: Not yet recruiting
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Fasciitis
• Fasciitis, Plantar
• Plantar Fasciitis
• Plantar Fasciitis, Chronic
• Ultrasound Therapy

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