Intense Therapeutic Ultrasound (ITU) to Treat Plantar Fasciitis

Universidad Complutense de Madrid

Status: Unknown

Conditions: Ultrasound Therapy; Plantar Fasciitis; Plantar Fasciitis, Chronic

Treatments: Device: Intense Therapeutic Ultrasound

Study type: Interventional

Funder types: Other

Identifiers

NCT04125264

18/399-R_P

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

30 participants in 2 patient groups

Intense therapeutic Ultrasound

Experimental group

Description:

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.

Treatment:

Device: Intense Therapeutic Ultrasound

Control group

No Intervention group

Description:

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.