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Piezowave for Treatment on Lateral and Medial Elbow Tendinopathies

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: NCT04241484
Recruitment Status : Withdrawn (PI left the institution)
First Posted : January 27, 2020
Last Update Posted : May 4, 2020
Sponsor:
Information provided by (Responsible Party):
Johns Hopkins University

Tracking Information
First Submitted Date  ICMJE January 22, 2020
First Posted Date  ICMJE January 27, 2020
Last Update Posted Date May 4, 2020
Estimated Study Start Date  ICMJE April 1, 2020
Estimated Primary Completion Date March 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 22, 2020)
Change in Function as demonstrated by Quick score [ Time Frame: The Quick score will be completed by the participant at the initial evaluation or session and repeated at visit 10 or at day 30 day post-intervention, which ever comes first. ]
The Quick (Disability of the Arm, Shoulder and Hand) score will assess participant report of function based on daily activities by creating an upper extremity functional score. There are 11 questions that ask the participant to rate their difficulty or limitations and pain in order to complete specific tasks. Each questions will ask the participant to select one of the five measures from no difficulty, not limited at all or none to unable, extreme and I can't sleep, with the latter of the measures indicating decreased upper extremity function. A maximum total score of 55 and minimum of 11.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 22, 2020)
Change in Pain level as demonstrate by the numeric pain rating scale [ Time Frame: The participant will be asked to report their pain will be completed by the participant at the initial evaluation or session and repeated at visit 10 or at day 30 day post-intervention, which ever comes first. ]
The participant will document their pain level as assessed by the numeric pain rating scale from 0 to 10. 0 represents no pain and 10 represents the greatest level of pain.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Piezowave for Treatment on Lateral and Medial Elbow Tendinopathies
Official Title  ICMJE Piezowave Myofascial Acoustic Compression Therapy on Lateral and Medial Tendinopathies
Brief Summary

Within the outpatient rehabilitation clinic, therapists provide therapeutic interventions to treat patients with various tendinopathies, including lateral and medial epicondylosis. Current conservative treatment includes immobilization for forced rest of the inflamed tendons and muscles, as well as mobilizations to focus stimulation of synovial fluid, provide movement to nourish cartilage, promote periarticular extensibility, and provide sensory and proprioceptive input. Musculoskeletal disorders can accompany both local and referred pain patterns that need to be assessed and treated. When an acute trauma or repetitive micro-trauma occurs, that may result in decreased range of motion and increased pain causing the onset of weakness and function of the affected extremity. An alternative approach is through the provision of Piezowave Myofascial Acoustic Compression Therapy (MyACT), which provides mechanical stimuli delivery to improve circulation and provide relief of pain. The focused sound waves produced by the Piezowave MyACT device are classified by a pressure surge, which is followed by a drop in pressure and a brief negative pressure phase low energy/low pressure application. It is this transformation of mechanical stimuli into biochemical signals, or mechanotransduction, which yields the treatment of myofascial and musculoskeletal pain. There is currently limited research to support the benefit in regards to increased function and decreased pain when the Piezowave MyACT is used for the treatment of lateral and medial epicondylosis. Of the limited research available, treatment with non-invasive shock wave therapy, complications are low and effect is achieved in most cases within three to five sessions.

If Piezowave Myofascial Acoustic Compression Therapy (MyACT)) is applied as treatment for symptoms of lateral and medical elbow tendinopathies, then the patient will experience increased function demonstrated by Quick DASH (Disability of the Arm, Shoulder and Hand) score and decreased pain demonstrated by subjective reporting on the numeric pain rating scale.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Elbow Tendinopathy
  • Golfer's Elbow
  • Medial Epicondylitis
  • Lateral Epicondylitis
  • Tennis Elbow
Intervention  ICMJE Device: Piezowave 2
Piezowave Myofascial Acoustic Compression Therapy (MyACT), which provides mechanical stimuli delivery to improve circulation and provide relief of pain. The focused sound waves produced by the Piezowave MyACT device are classified by a pressure surge, which is followed by a drop in pressure and a brief negative pressure phase low energy/low pressure application. It is this transformation of mechanical stimuli into biochemical signals, or mechanotransduction, which yields the treatment of myofascial and musculoskeletal pain
Study Arms  ICMJE Experimental: Piezowave
  • Initiation of Piezowave MyACT treatment to include parameters from the user manual
  • Set for frequency of five pulses per second
  • Delivery of 500 to 1000 pulses over multiple injured area sites, not to exceed 4000 pulses per session
  • Intensity ranging from 0.1 to 18 millijoule per square millimeter. This intensity if energy flux as the rate of transfer of the energy through the surface of the tissue is applied.
  • Focal transducer
  • Head size will be variable based on depth of tissue treated. The user manual will be consulted for depth of penetration recommendations
Intervention: Device: Piezowave 2
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: April 30, 2020)
0
Original Estimated Enrollment  ICMJE
 (submitted: January 22, 2020)
15
Estimated Study Completion Date  ICMJE March 1, 2021
Estimated Primary Completion Date March 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Tendinopathy symptoms referred for occupational therapy by physician.
  • Positive provocation tests

Exclusion Criteria:

  • Contraindications for shock wave

    • Infections
    • Tumor tissue
    • Blood clotting disorder
    • Blood thinning medication use
    • Pregnancy
    • Lung tissue in focal area
    • Head
    • Air-containing organs
    • Elbow fracture
  • History of corticosteroid injections less than eight weeks/two months, prior to initiation of occupation therapy treatment for lateral or medial epicondylosis. The goal would be to have elimination of any residual benefit from the injection.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 22 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04241484
Other Study ID Numbers  ICMJE IRB00237364
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Johns Hopkins University
Study Sponsor  ICMJE Johns Hopkins University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Christa Schestag, MSOT Outpatient Rehabilitation Services
PRS Account Johns Hopkins University
Verification Date April 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP