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

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ClinicalTrials.gov Identifier: NCT03255655
Recruitment Status : Completed
First Posted : August 21, 2017
Results First Posted : December 13, 2017
Last Update Posted : December 13, 2017
Sponsor:
Collaborator:
University of Arizona
Information provided by (Responsible Party):
Guided Therapy Systems

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Investigator);   Primary Purpose: Treatment
Condition Chronic Plantar Fasciitis
Intervention Device: Intense Therapeutic Ultrasound Treatment - ITU
Enrollment 41
Recruitment Details Patients 18 - 85 years previously diagnosed with unilateral Chronic Plantar Fasciitis (>90 days), where Standard of Care therapies had failed to reduce pain.
Pre-assignment Details  
Arm/Group Title ITU Treatment for Chronic Plantar Fasciitis Sham ITU Treatment for Chronic Plantar Fasciitis
Hide Arm/Group Description

Intense Therapeutic Ultrasound (ITU) treatment applied along the length and width of the Plantar Fascia: 350 - 5 Joule pulses were applied twice, two weeks apart.

Intense Therapeutic Ultrasound Treatment - ITU

Sham / Placebo Intense Therapeutic Ultrasound treatment (ITU) applied along the length and width of the Plantar Fascia: 350 - 0 Joule pulses were applied twice, two weeks apart.

Intense Therapeutic Ultrasound Treatment - ITU

Period Title: Overall Study
Started 29 12
Completed 22 8
Not Completed 7 4
Reason Not Completed
Lost to Follow-up             7             4
Arm/Group Title ITU Treatment for Chronic Plantar Fasciitis Sham ITU Treatment for Chronic Plantar Fasciitis Total
Hide Arm/Group Description

Intense Therapeutic Ultrasound (ITU) treatment applied along the length and width of the Plantar Fascia: 350 - 5 Joule pulses were applied twice, two weeks apart.

Intense Therapeutic Ultrasound Treatment - ITU

Sham / Placebo Intense Therapeutic Ultrasound treatment (ITU) applied along the length and width of the Plantar Fascia: 350 - 0 Joule pulses were applied twice, two weeks apart.

Intense Therapeutic Ultrasound Treatment - ITU

Total of all reporting groups
Overall Number of Baseline Participants 29 12 41
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 29 participants 12 participants 41 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
28
  96.6%
11
  91.7%
39
  95.1%
>=65 years
1
   3.4%
1
   8.3%
2
   4.9%
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 29 participants 12 participants 41 participants
54
(35 to 83)
47
(34 to 83)
51
(34 to 83)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 29 participants 12 participants 41 participants
Female
24
  82.8%
8
  66.7%
32
  78.0%
Male
5
  17.2%
4
  33.3%
9
  22.0%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants
0
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 29 participants 12 participants 41 participants
29 12 41
1.Primary Outcome
Title Average Percentage of Change as Reported Using Foot Function Index Pain Subscale
Hide Description 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 average percentage change of the FFI score at 12 weeks, compared to the average FFI score at baseline.
Time Frame 12 weeks after 1st Treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Total population of respondents at 12 weeks.
Arm/Group Title ITU Treatment for Chronic Plantar Fasciitis Sham ITU Treatment for Chronic Plantar Fasciitis
Hide Arm/Group Description:

Intense Therapeutic Ultrasound (ITU) treatment applied along the length and width of the Plantar Fascia: 350 - 5 Joule pulses were applied twice, two weeks apart.

Intense Therapeutic Ultrasound Treatment - ITU

Sham / Placebo Intense Therapeutic Ultrasound treatment (ITU) applied along the length and width of the Plantar Fascia: 350 - 0 Joule pulses were applied twice, two weeks apart.

Intense Therapeutic Ultrasound Treatment - ITU

Overall Number of Participants Analyzed 22 8
Mean (Full Range)
Unit of Measure: percentage of Change
-54
(-100 to 100)
-25
(-100 to 100)
2.Primary Outcome
Title Mean Percentage Change in Volume of Plantar Fascia Hypoechoic Lesions by Diagnostic Ultrasound Imaging
Hide Description 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).
Time Frame 12 Weeks after the first Treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Male and Female previously diagnosed with Chronic Plantar Fasciitis, between the age of 18 and 85.
Arm/Group Title ITU Treatment for Chronic Plantar Fasciitis Sham ITU Treatment for Chronic Plantar Fasciitis
Hide Arm/Group Description:

Intense Therapeutic Ultrasound (ITU) treatment applied along the length and width of the Plantar Fascia: 350 - 5 Joule pulses were applied twice, two weeks apart.

Intense Therapeutic Ultrasound Treatment - ITU

Sham / Placebo Intense Therapeutic Ultrasound treatment (ITU) applied along the length and width of the Plantar Fascia: 350 - 0 Joule pulses were applied twice, two weeks apart.

Intense Therapeutic Ultrasound Treatment - ITU

Overall Number of Participants Analyzed 22 8
Mean (Standard Error)
Unit of Measure: percentage of Hypoechoic Lesion Change
-81  (8) 26  (4)
Time Frame 2 years, 9 months
Adverse Event Reporting Description Any Patient Self-Reported Adverse Event occurring during the treatment or during the Follow-up Period.
 
Arm/Group Title ITU Treatment for Chronic Plantar Fasciitis Sham ITU Treatment for Chronic Plantar Fasciitis
Hide Arm/Group Description

Intense Therapeutic Ultrasound (ITU) treatment applied along the length and width of the Plantar Fascia: 350 - 5 Joule pulses were applied twice, two weeks apart.

Intense Therapeutic Ultrasound Treatment - ITU

Sham / Placebo Intense Therapeutic Ultrasound treatment (ITU) applied along the length and width of the Plantar Fascia: 350 - 0 Joule pulses were applied twice, two weeks apart.

Intense Therapeutic Ultrasound Treatment - ITU

All-Cause Mortality
ITU Treatment for Chronic Plantar Fasciitis Sham ITU Treatment for Chronic Plantar Fasciitis
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
ITU Treatment for Chronic Plantar Fasciitis Sham ITU Treatment for Chronic Plantar Fasciitis
Affected / at Risk (%) Affected / at Risk (%)
Total   0/29 (0.00%)   0/12 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
ITU Treatment for Chronic Plantar Fasciitis Sham ITU Treatment for Chronic Plantar Fasciitis
Affected / at Risk (%) Affected / at Risk (%)
Total   0/29 (0.00%)   0/12 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Rich Amodei, RDMS
Organization: Guided Therapy Systems
Phone: 480-649-8587
Responsible Party: Guided Therapy Systems
ClinicalTrials.gov Identifier: NCT03255655     History of Changes
Other Study ID Numbers: GTS - ITU UA Plantar Fascia 01
First Submitted: August 17, 2017
First Posted: August 21, 2017
Results First Submitted: October 20, 2017
Results First Posted: December 13, 2017
Last Update Posted: December 13, 2017