Intense Therapeutic Ultrasound (ITU) to Treat Plantar Fasciitis

NCT04125264 | Unknown FDA Device

• 1 other identifier: 18/399-R_P
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Plantar Fasciitis; Plantar Fasciitis, Chronic; Ultrasound Therapy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Hypoechoic volume area reduction

  24 weeks

• Ankle range of motion reduction

  24 weeks

• Time to incorporation to daily live activities

  24 weeks

• Autonomous gait without pain in the heel

  24 weeks

• Improvement of patients satisfaction

  24 weeks

Study Arms (2)

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.

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.

Interventions

Intense Therapeutic Ultrasound DEVICE

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.

Intense therapeutic Ultrasound

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad Complutense de Madrid: lead

Study Sites (1)

Diabetic foot Unit Complutense University

Madrid, 28040, Spain

Location

MeSH Terms

Conditions

Fasciitis, Plantar

Condition Hierarchy (Ancestors)

Fasciitis; Musculoskeletal Diseases; Foot Diseases

Study Officials

• José Luis Lázaro Martínez, Phd

  Universidad Complutense Madrid

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Raúl J. Molines Barroso, Phd

CONTACT

639059104; rauljmolines@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Patient located in experimental group will be treated with ITU. Patient located in control group will be treated with the same protocoll of ITU without intensity.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Model Details: Randomized, Non-probabilistic and Superiority Controlled Clinical Trial.

Study Record Dates

• First Submitted: October 10, 2019
• First Posted: October 14, 2019
• Study Start: October 1, 2019
• Primary Completion: October 1, 2020
• Study Completion: October 1, 2021
• Last Updated: October 16, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)