Tennis Elbow
Conditions
Brief summary
The purpose of this study is to assess the efficacy of using a percussive therapy device in addition to physical therapy to treat acute tennis elbow
Detailed description
The device the investigators intend to use is Class I and in a class of devices that is exempt from the FDA requirement for premarket notification/approval (exempt from 510K or PMA), which would not be subject to section 510(k), 515, or 520(m) of the Federal Food, Drug, and Cosmetic Act (ref: FDAAA Checklist)
Interventions
DEVICEPercussive Therapy Device
Same as group description
BEHAVIORALPhysical Therapy
Same as group description
Sponsors
Therabody, Inc.
Cedars-Sinai Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Individuals 18 years old or older are included * Patients with atraumatic lateral epicondylitis symptoms * Symptoms persistent and present for at least 2 weeks * Presence of 2 of the following on clinical examination: +tenderness to palpation common extensor tendons and/or lateral epicondyle origin, pain over the lateral elbow with passive flexion of the wrist in an extended position, +pain with resisted supination, +pain with resisted middle finger extension.
Exclusion criteria
* Any records flagged break the glass or research opt out. * Patients with elbow osteoarthritis, * Patients with a history of traumatic injury to the elbow * Patients with workers compensation * Patients who received cortisol injection in the elbow * MRI evidence of common extensor tear * A history of surgery on the affected elbow, * Cognitive or behavioral problems which would preclude informed consent. * Patients with coagulopathies * Patients who are pregnant * Patients who had a cortisone injection within 3 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to Improvement of Symptoms | 3 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PROMIS Physical Functioning | 3 months | Patient-Reported Outcomes Measurement Information System Physical function 0-100 indicating overall functionality with higher scores representing more functionality |
| PROMIS Pain Interference | 3 months | Patient-Reported Outcomes Measurement Information System Pain interference 0-100 measures the extent to which pain hinders an individual's engagement with physical, mental, cognitive, emotional, recreational, and social activities with higher scores representing more interference |
| PROMIS Upper Extremity | 3 months | Patient-Reported Outcomes Measurement Information System Upper extremity - 0-100 indicating functionality of the upper extremity with higher scores representing more functionality |
| VAS pain score | 3 months | Visual Analog Score for pain - subjective measure for acute and chronic pain. Scaled 0-10 |
| SANE score | 3 months | Single Assessment Numeric Evaluation - This is a single-question outcome measure that asks patients to rate their function, as it pertains to the area being treated, on a scale of 0 to 100 |
| PROMIS Depression | 3 months | Patient-Reported Outcomes Measurement Information System Depression - 0-100 assess self-reported negative mood (sadness, guilt), views of self (self- criticism, worthlessness), and social cognition (loneliness, interpersonal alienation), as well as decreased positive affect and engagement (loss of interest, meaning, and purpose) with higher scores indicating more depression |
Countries
United States
Contacts
Primary ContactJoshua Langberg, B.A
Outcome results
None listed