NCT03255655: ITU

Intense Therapeutic Ultrasound - Treatment for Chronic Plantar Fascia Musculoskeletal Pain Reduction

Completed NA Results posted Last updated 13 December 2017

What this trial tests

NA trial testing Intense Therapeutic Ultrasound Treatment - ITU in Chronic Plantar Fasciitis in 41 participants. Completed in 1 March 2016.

Timeline

22 October 2014

Primary endpoint
1 March 2016

1 March 2016

Quick facts

Lead sponsor	Guided Therapy Systems
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	41
Start date	22 October 2014
Primary completion	1 March 2016
Estimated completion	1 March 2016
Sites	1 location across United States

Drugs / interventions tested

• Intense Therapeutic Ultrasound Treatment - ITU

Conditions studied

• Chronic Plantar Fasciitis — all drugs for Chronic Plantar Fasciitis →

Sponsor

Guided Therapy Systems

Who can join

Adults 18 to 85, any sex, with Chronic Plantar Fasciitis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Average Percentage of Change as Reported Using Foot Function Index Pain Subscale Primary · 12 weeks after 1st Treatment

Average Percentage of Change as Reported using Foot Function Index (FFI) pain subscale. Range (±100%). Foot Function Index pain subscale is a measure of pain and disability and activity limitation based 9 questions, each with a possible pain score of 0 - 10, where 0 indicates no pain during the described activity and 10 indicates the worst imaginable pain during a described activity. A summed total score of 0 indicates the patient had no pain for all activities. A score of 90 indicates the patient experiences the worst imaginable pain for all the described activities. The results compare the a

Group	Value	95% CI
ITU Treatment for Chronic Plantar Fasciitis	-54	-100 – 100
Sham ITU Treatment for Chronic Plantar Fasciitis	-25	-100 – 100

Mean Percentage Change in Volume of Plantar Fascia Hypoechoic Lesions by Diagnostic Ultrasound Imaging Primary · 12 Weeks after the first Treatment

Mean Percentage Change in Volume of Plantar Fascia Hypoechoic Lesions by Diagnostic Ultrasound Imaging compared to Baseline Volume, where volume is calculated using: (4/3)π x R1 x R2 x R3, where R = Radius of each measurement: Lesion Length (1), Width (2), Depth (3).

Group	Value	95% CI
ITU Treatment for Chronic Plantar Fasciitis	-81	± 8
Sham ITU Treatment for Chronic Plantar Fasciitis	26	± 4

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.