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Clinical Trials/NCT04125264
NCT04125264
Unknown
N/A

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

Universidad Complutense de Madrid1 site in 1 country30 target enrollmentOctober 2019

Overview

Phase
N/A
Intervention
Not specified
Conditions
Plantar Fasciitis
Sponsor
Universidad Complutense de Madrid
Enrollment
30
Locations
1
Primary Endpoint
Pain reduction
Last Updated
6 years ago

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.

Registry
clinicaltrials.gov
Start Date
October 2019
End Date
October 2021
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Raúl Juan Molines Barroso, Phd

Clinical Professor

Universidad Complutense de Madrid

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.

Outcomes

Primary Outcomes

Pain reduction

Time Frame: 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

Time Frame: 24 weeks

Longitudinal view of the plantar fasciia with the use of ultrasound probe.

Secondary Outcomes

  • 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 Sites (1)

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