Clinical trial NCT04241484: Piezowave for Treatment on Lateral and Medial Elbow Tendinopathies
Official title: Piezowave Myofascial Acoustic Compression Therapy on Lateral and Medial Tendinopathies
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Elbow Tendinopathy
Golfer's Elbow
Medial Epicondylitis
Lateral Epicondylitis
Tennis Elbow
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2020-01-27
Enrollment: 0
Sex: ALL
Minimum age (years): 22
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Change in Function as demonstrated by Quick score
timeFrame: 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 outcomes:
measure: Change in Pain level as demonstrate by the numeric pain rating scale
timeFrame: 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.
Other outcomes:
Locations:
Study officials:
affiliation: Outpatient Rehabilitation Services
name: Christa Schestag, MSOT
role: PRINCIPAL_INVESTIGATOR
References: