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

Primary Purpose

Plantar Fasciitis, Plantar Fasciitis, Chronic, Ultrasound Therapy

Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Intense Therapeutic Ultrasound
Sponsored by
Universidad Complutense de Madrid
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Plantar Fasciitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Diabetic foot Unit Complutense University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intense therapeutic Ultrasound

Control group

Arm 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.

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.

Outcomes

Primary Outcome Measures

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.
Plantar fasciia thickness reduction
Longitudinal view of the plantar fasciia with the use of ultrasound probe.

Secondary Outcome Measures

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

Full Information

First Posted
October 10, 2019
Last Updated
October 14, 2019
Sponsor
Universidad Complutense de Madrid
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1. Study Identification

Unique Protocol Identification Number
NCT04125264
Brief Title
Intense Therapeutic Ultrasound (ITU) to Treat Plantar Fasciitis
Acronym
ITU
Official Title
The Application of Intense Therapeutic Ultrasound in Plantar Fasciitis. A Randomized, Non-probabilistic and Superiority Controlled Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Unknown status
Study Start Date
October 2019 (Anticipated)
Primary Completion Date
October 2020 (Anticipated)
Study Completion Date
October 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad Complutense de Madrid

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Plantar Fasciitis, Plantar Fasciitis, Chronic, Ultrasound Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized, Non-probabilistic and Superiority Controlled Clinical Trial.
Masking
None (Open Label)
Masking Description
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.
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intense therapeutic Ultrasound
Arm Type
Experimental
Arm 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.
Arm Title
Control group
Arm Type
No Intervention
Arm 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.
Intervention Type
Device
Intervention Name(s)
Intense Therapeutic Ultrasound
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pain reduction
Description
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.
Time Frame
24 weeks
Title
Plantar fasciia thickness reduction
Description
Longitudinal view of the plantar fasciia with the use of ultrasound probe.
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Hypoechoic volume area reduction
Description
Longitudinal and transversal view of the hypoechoic area of plantar fasciia with the use of ultrasound probe.
Time Frame
24 weeks
Title
Ankle range of motion reduction
Description
Goniometry of the ankle in the extended and flexed position of the knee
Time Frame
24 weeks
Title
Time to incorporation to daily live activities
Description
Patients satisfaction scale (6 items)
Time Frame
24 weeks
Title
Autonomous gait without pain in the heel
Description
Patients autonomous gait scale (6 items)
Time Frame
24 weeks
Title
Improvement of patients satisfaction
Description
Patients satisfaction scale (6 items)
Time Frame
24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Raúl J. Molines Barroso, Phd
Phone
639059104
Ext
+34
Email
rauljmolines@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
José Luis Lázaro Martínez, Phd
Organizational Affiliation
Universidad Complutense Madrid
Official's Role
Principal Investigator
Facility Information:
Facility Name
Diabetic foot Unit Complutense University
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Raúl Juan Molines Barroso, Phd
Phone
639059104
Ext
+34
Email
rauljmolines@hotmail.com
First Name & Middle Initial & Last Name & Degree
José Luis Lázaro Martínez, Phd
First Name & Middle Initial & Last Name & Degree
Ángel Manuel Orejana García, Phd
First Name & Middle Initial & Last Name & Degree
Pedro Villalta García, Phd
First Name & Middle Initial & Last Name & Degree
Marta López Herranz, Phd

12. IPD Sharing Statement

Plan to Share IPD
No

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Intense Therapeutic Ultrasound (ITU) to Treat Plantar Fasciitis

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