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ITU Treatment for Chronic Epicondylitis Musculoskeletal Pain Reduction (ITU)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03255733
Recruitment Status : Completed
First Posted : August 21, 2017
Results First Posted : November 17, 2017
Last Update Posted : November 17, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Tennis Elbow
Intervention: Device: Intense Therapeutic Ultrasound Treatment

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

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
Intense Therapeutic Ultrasound Treatment

Intense Therapeutic Ultrasound applied along and length and width of the Common Extensor Tendon. 80, 1 Joule pulses were applied twice, four weeks apart.

Intense Therapeutic Ultrasound Treatment


Participant Flow:   Overall Study
    Intense Therapeutic Ultrasound Treatment
STARTED   29 
COMPLETED   25 
NOT COMPLETED   4 
Lost to Follow-up                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
Intense Therapeutic Ultrasound Treatment

Intense Therapeutic Ultrasound applied along and length and width of the Common Extensor Tendon. 80, 1 Joule pulses were applied twice, four weeks apart.

Intense Therapeutic Ultrasound Treatment


Baseline Measures
   Intense Therapeutic Ultrasound Treatment 
Overall Participants Analyzed 
[Units: Participants]
 29 
Age 
[Units: Participants]
Count of Participants
 
Participants Analyzed 
[Units: Participants]
 29 
<=18 years      0   0.0% 
Between 18 and 65 years      28  96.6% 
>=65 years      1   3.4% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Participants Analyzed 
[Units: Participants]
 29 
Female      12  41.4% 
Male      17  58.6% 
Race and Ethnicity Not Collected [1] 
[Units: Participants]
Count of Participants
  
[1] Race and Ethnicity were not collected from any participant.
Region of Enrollment 
[Units: Participants]
Count of Participants
 
United States   
Participants Analyzed 
[Units: Participants]
 29 
United States   29 


  Outcome Measures

1.  Primary:   Percentage of Patients Reporting at Least 25% Overall Pain Reduction   [ Time Frame: 12 weeks after 1st Treatment ]

2.  Secondary:   Average Pain Score Change as Reported Using Patient Rated Tennis Elbow Evaluation, During Normal Activities   [ Time Frame: 12 weeks after 1st 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
While the protocol involved Chronic patients, who had already failed Standard of Care regimens, it is a limitation for this investigational study to have no control group.


  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: NCT03255733     History of Changes
Other Study ID Numbers: GTS-ITU Epicondylosis 01
First Submitted: August 10, 2017
First Posted: August 21, 2017
Results First Submitted: August 21, 2017
Results First Posted: November 17, 2017
Last Update Posted: November 17, 2017