Intense Therapeutic Ultrasound (ITU) to Treat Plantar Fasciitis

Not Applicable

• Conditions: Plantar Fasciitis, Chronic; Plantar Fasciitis; Ultrasound Therapy
• Interventions: Device: Intense Therapeutic Ultrasound

• Registration Number: NCT04125264
• Lead Sponsor: Universidad Complutense de Madrid

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.

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 Timeline

• Status Verified: 2019-10
• Study Start: 2019-10
• Study First Submitted: 2019-10-10
• Study First Submitted QC: 2019-10-11
• Study First Posted: 2019-10-14
• Last Update Submitted: 2019-10-14
• Last Update Posted: 2019-10-16
• Primary Completion: 2020-10
• Study Completion: 2021-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intense therapeutic Ultrasound	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.

Primary Outcome Measures

Name	Time	Method
Pain reduction	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	24 weeks	Longitudinal view of the plantar fasciia with the use of ultrasound probe.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Diabetic foot Unit Complutense University; 🇪🇸 Madrid, Spain