search
Back to results

Piezowave for Treatment on Lateral and Medial Elbow Tendinopathies

Primary Purpose

Elbow Tendinopathy, Golfer's Elbow, Medial Epicondylitis

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Piezowave 2
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Elbow Tendinopathy

Eligibility Criteria

22 Years - 90 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Piezowave

    Arm Description

    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

    Outcomes

    Primary Outcome Measures

    Change in Function as demonstrated by Quick score
    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.

    Secondary Outcome Measures

    Change in Pain level as demonstrate by the numeric pain rating scale
    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.

    Full Information

    First Posted
    January 22, 2020
    Last Updated
    April 30, 2020
    Sponsor
    Johns Hopkins University
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT04241484
    Brief Title
    Piezowave for Treatment on Lateral and Medial Elbow Tendinopathies
    Official Title
    Piezowave Myofascial Acoustic Compression Therapy on Lateral and Medial Tendinopathies
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2020
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    PI left the institution
    Study Start Date
    April 1, 2020 (Anticipated)
    Primary Completion Date
    March 1, 2021 (Anticipated)
    Study Completion Date
    March 1, 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Johns Hopkins University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Elbow Tendinopathy, Golfer's Elbow, Medial Epicondylitis, Lateral Epicondylitis, Tennis Elbow

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Piezowave
    Arm Type
    Experimental
    Arm Description
    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 Type
    Device
    Intervention Name(s)
    Piezowave 2
    Intervention Description
    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
    Primary Outcome Measure Information:
    Title
    Change in Function as demonstrated by Quick score
    Description
    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.
    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.
    Secondary Outcome Measure Information:
    Title
    Change in Pain level as demonstrate by the numeric pain rating scale
    Description
    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.
    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.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    22 Years
    Maximum Age & Unit of Time
    90 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Christa Schestag, MSOT
    Organizational Affiliation
    Outpatient Rehabilitation Services
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Piezowave for Treatment on Lateral and Medial Elbow Tendinopathies

    We'll reach out to this number within 24 hrs