N/A
N=33
Intense Therapeutic Ultrasound for the Treatment of Chronic Plantar Fasciitis
Plantar Fasciitis, Chronic
Bottom Line
View on ClinicalTrials.gov: NCT03254602 ↗Enrolled (actual)
33
Serious AEs
0.0%
Results posted
Nov 2017
Primary outcome: Primary: Patient Reported Pain Via the Universal Visual Analog Scale: Pass Criteria = at Least 25% Pain Reduction — 86 Percent of Patients meeting criteria
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Intense Therapeutic Ultrasound Treatment (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University Foot and Ankle Foundation
- Primary completion
- Apr 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Patient Reported Pain Via the Universal Visual Analog Scale: Pass Criteria = at Least 25% Pain Reduction |
86 | — |
| SECONDARY Ultrasound Changes |
56 | — |
| SECONDARY Percentage of Change of Pain and Hypoechoic Lesion Volume Compared to Baseline |
-54; -56 | — |
Summary
A clinical trial evaluating the effectiveness, safety and patient tolerance for the use of Intense Therapeutic Ultrasound (ITU) for chronic, Plantar Fasciitis musculoskeletal tissue pain reduction began in August 2016 and was completed in April 2017. The clinical setting: University Foot and Ankle Institute, Santa Monica, California, USA; Single-Blinded, pivotal study for chronic plantar fasciitis.
Eligibility Criteria
Inclusion Criteria
- Chronic Pain (>90 days) from previously diagnosed Plantar Fasciitis, where "Standard of Care" regimens failed to relief pain in the affected anatomy.
- No History of surgery to the affected anatomy.
- No alternative treatment procedures within the last 90 days.
- Age: 18 - 85, depending on the study.
- Unilateral Pain
- Willingness to complete treatment and post treatment regimen as described.
- Patients who have provided written and verbal informed consent.
Exclusion Criteria
- Patients currently enrolled in any other non-conservative, device, or Investigational New Drug clinical trial, or who have participated in a clinical study involving the Plantar Fascia, thirty days prior to study initiation;
- Patients who have participated in any other clinical study involving an investigational product 30 days prior to enrollment that, in the opinion of the Principal Investigator, could affect the outcome of this study;
- Patients who have received previous treatment in the symptomatic limb (not including conservative treatment);
- At the Principal Investigator's discretion, any patient that should be excluded based on their current condition or medical history.
Data sourced from ClinicalTrials.gov (NCT03254602). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.