Intense Therapeutic Ultrasound (ITU) to Treat Plantar Fasciitis (ITU)

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.

Study Overview

• Status: Unknown
• Conditions: Plantar Fasciitis; Ultrasound Therapy; Plantar Fasciitis, Chronic
• Intervention / Treatment: Device: Intense Therapeutic Ultrasound

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 Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain, 28040
    • Diabetic foot Unit Complutense University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Intense therapeutic Ultrasound; 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.	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.
NO_INTERVENTION: Control group; 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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Plantar fasciia thickness reduction	Longitudinal view of the plantar fasciia with the use of ultrasound probe.	24 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Universidad Complutense de Madrid
• Investigators: Principal Investigator: José Luis Lázaro Martínez, Phd, UNIVERSIDAD COMPLUTENSE MADRID

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): October 1, 2019
• Primary Completion (ANTICIPATED): October 1, 2020
• Study Completion (ANTICIPATED): October 1, 2021

Study Registration Dates

• First Submitted: October 10, 2019
• First Submitted That Met QC Criteria: October 11, 2019
• First Posted (ACTUAL): October 14, 2019

Study Record Updates

• Last Update Posted (ACTUAL): October 16, 2019
• Last Update Submitted That Met QC Criteria: October 14, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Foot Diseases; Musculoskeletal Diseases; Fasciitis; Fasciitis, Plantar
• Other Study ID Numbers: 18/399-R_P

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes