CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 41 enrolled
Drug / intervention
Intense Therapeutic Ultrasound Treatment - ITUdevice
Likely dose
Not stated in record
Key inclusion· 5
  • Chronic plantar fasciitis pain lasting more than 90 days that has failed standard of care treatment
  • No prior surgery on the affected foot/plantar fascia
  • No alternative treatment procedures within the last 90 days
  • Pain limited to one foot (unilateral)
Key exclusion· 4
  • Currently enrolled in another non-conservative, device, or investigational drug trial
  • Participation in any clinical study involving an investigational product within 30 days prior to enrollment that could affect outcomes
  • Prior non-conservative treatment to the symptomatic limb (excluding conservative treatment)
  • Any condition or medical history that the Principal Investigator deems disqualifying

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03255655
NCT03255655N/ACompleted

Intense Therapeutic Ultrasound for Chronic Plantar Fascia Musculoskeletal Pain Reduction

Guided Therapy Systems·interventional·Posted Aug 21, 2017·Updated Dec 13, 2017

In Brief

A clinical study evaluating Intense Therapeutic Ultrasound Treatment - ITU for Chronic Plantar Fasciitis. Completed, enrolled 41 participants across 1 site.

Detailed Summary

Double-blinded feasibility study for the treatment of pain related to chronic plantar fasciitis. A total 37 patients (27 treated and 12 control/sham treated) received 2 treatments, 2 weeks apart on subcutaneous plantar fascia musculoskeletal tissue along with Standard of Care treatments as prescribed by the Principal Investigator. Patients were followed for up to 6 months after the first treatment receiving a physical exam at each follow-up visit (4, 8 and 12 weeks) and provided feedback via Patient/Subject Reported Outcome Measure surveys specific to the treated anatomy at each visit and via phone follow-up at 26 weeks after the first treatment.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
201520162017201820192020202120222023202420252026
First PostedAug 21, 2017
Enrollment StartOct 22, 2014
Primary CompletionMar 1, 2016
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 8.9 years ago

Interventions

Intense Therapeutic Ultrasound Treatment - ITUdevice