Clinical Trials Logo

Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT04241484
Other study ID # IRB00237364
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
Start date April 1, 2020
Est. completion date March 1, 2021

Study information

Verified date April 2020
Source Johns Hopkins University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date March 1, 2021
Est. primary completion date March 1, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 22 Years to 90 Years
Eligibility 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.

Study Design


Intervention

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

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Johns Hopkins University

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 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 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. 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.
See also
  Status Clinical Trial Phase
Active, not recruiting NCT02308514 - Does Adding Cryostimulation to Conservative Care Help in Managing Chronic Lateral Epicondylitis? a Pilote Study N/A
Completed NCT02596659 - Effectiveness of Radial Extracorporeal Shockwave Therapy on Tennis Elbow N/A
Completed NCT00674622 - Prolotherapy for the Treatment of Chronic Lateral Epicondylitis Phase 2/Phase 3
Completed NCT06206109 - The Effect of Tendon Tears on Lateral Epicondylitis
Completed NCT06301152 - Lateral Epicondylitis Treatment High Intensive Laser Therapy and Extracorporeal Shock Wave Therapy N/A
Not yet recruiting NCT04382144 - Levobupivacaine Versus Liposomal Bupivacaine (Exparel®) for Treatment of Pain and Disability in Lateral Epicondylitis Phase 4
Recruiting NCT03863847 - A Neurofeedback Treatment for Chronic Musculoskeletal Pain N/A
Recruiting NCT05648032 - PLT and Steroid in Lateral Epicondylopathy and Supraspinatus Calcific Tendinopathy Phase 3
Completed NCT06300749 - Effectiveness of Chiropractic Cervical Manipulation in Lateral Epicondylitis N/A
Completed NCT00794976 - Dexamethasone Iontophoretic Patch for the Treatment of Pain Associated With Lateral Epicondylitis Phase 2
Completed NCT00888225 - Tennis Elbow Trial N/A
Completed NCT06087081 - Mills Manipulation and Mulligan PRP Affect Pain, Grip Strength and Function on Lateral Epicondylitis N/A
Completed NCT05602571 - The Effectiveness of the Combination of PRP and ESWT in Lateral Epicondylitis N/A
Completed NCT05566418 - Immediate and Longterm Effects of Mulligan Mobilization With and Without Myofascial Release on Pain,Grip Strength and Function in Patients With Lateral Epicondylitis N/A
Not yet recruiting NCT03279796 - Treatment of Tendon Disease Using Autologous Adipose-derived Mesenchymal Stem Cells Phase 2
Completed NCT04687943 - Comparison of PELOID Therapy and Kinesio Tape Effectiveness in Patients With Lateral Epicondylitis
Recruiting NCT05947968 - Scapular PNF Versus Shoulder Strengthening Exercises in Patients With Lateral Epicondylitis. N/A
Active, not recruiting NCT06438328 - Effectiveness of Scapular Muscle Training in Improving Grip Strength Among Lateral Epicondylitis Patients N/A
Completed NCT06317545 - Effects of Nerchal Exercises on Lateral Epicondylitis. N/A
Completed NCT05070559 - Active Release Technique and Graston Technique in Patients With Lateral Epicondylitis N/A