NCT04241484

Piezowave for Treatment on Lateral and Medial Elbow Tendinopathies

Withdrawn NA Last updated 4 May 2020

What this trial tests

NA trial testing Piezowave 2 in Elbow Tendinopathy. Withdrawn.

Timeline

1 April 2020

Primary endpoint
1 March 2021

1 March 2021

Quick facts

Lead sponsor	Johns Hopkins University
Phase	NA
Status	Withdrawn
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Start date	1 April 2020
Primary completion	1 March 2021
Estimated completion	1 March 2021

Drugs / interventions tested

• Piezowave 2

Conditions studied

• Elbow Tendinopathy — all drugs for Elbow Tendinopathy →
• Golfer's Elbow — all drugs for Golfer's Elbow →
• Medial Epicondylitis — all drugs for Medial Epicondylitis →
• Lateral Epicondylitis — all drugs for Lateral Epicondylitis →

Sponsor

Johns Hopkins University

Who can join

Adults 22 to 90, any sex, with Elbow Tendinopathy or Golfer's Elbow. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.