Intense Therapeutic Ultrasound (ITU) to Treat Plantar Fasciitis

Study Overview
=================
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.

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

Conditions
-----------------
Plantar Fasciitis, Plantar Fasciitis, Chronic, Ultrasound Therapy

Intervention / Treatment
-----------------
* Device: Intense Therapeutic Ultrasound


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized, Non-probabilistic and Superiority Controlled Clinical Trial.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intense therapeutic Ultrasound<br>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<br>* 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.<br>|
| No Intervention: Control group<br>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 |