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Withdrawn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
About this trial
This is an interventional treatment trial for Elbow Tendinopathy
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.
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
NCT ID
NCT04241484
First Posted
January 22, 2020
Last Updated
April 30, 2020
Sponsor
Johns Hopkins University
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
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Piezowave for Treatment on Lateral and Medial Elbow Tendinopathies
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