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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:
Information provided by (Responsible Party):

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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
ITU Treatment for Chronic Plantar Fasciitis

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 ITU Treatment for Chronic Plantar Fasciitis

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


Participant Flow:   Overall Study
    ITU Treatment for Chronic Plantar Fasciitis   Sham ITU Treatment for Chronic Plantar Fasciitis
STARTED   29   12 
COMPLETED   22   8 
NOT COMPLETED   7   4 
Lost to Follow-up                7                4 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
ITU Treatment for Chronic Plantar Fasciitis

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 ITU Treatment for Chronic Plantar Fasciitis

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 Total of all reporting groups

Baseline Measures
   ITU Treatment for Chronic Plantar Fasciitis   Sham ITU Treatment for Chronic Plantar Fasciitis   Total 
Overall Participants Analyzed 
[Units: Participants]
 29   12   41 
Age 
[Units: Participants]
Count of Participants
     
Participants Analyzed 
[Units: Participants]
 29   12   41 
<=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 
[Units: Years]
Mean (Full Range)
     
Participants Analyzed 
[Units: Participants]
 29   12   41 
   54 
 (35 to 83) 
 47 
 (34 to 83) 
 51 
 (34 to 83) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Participants Analyzed 
[Units: Participants]
 29   12   41 
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] 
[Units: Participants]
Count of Participants
     
Participants Analyzed 
[Units: Participants]
 0   0   0 
         0 
[1] Race and Ethnicity were not collected from any participant.
Region of Enrollment 
[Units: Participants]
     
United States       
Participants Analyzed 
[Units: Participants]
 29   12   41 
United States   29   12   41 


  Outcome Measures

1.  Primary:   Average Percentage of Change as Reported Using Foot Function Index Pain Subscale   [ Time Frame: 12 weeks after 1st Treatment ]

2.  Primary:   Mean Percentage Change in Volume of Plantar Fascia Hypoechoic Lesions by Diagnostic Ultrasound Imaging   [ Time Frame: 12 Weeks after the first Treatment ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

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
e-mail: r.amodei@guidedtherapy.com


Publications:

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