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Treatment of Lateral Epicondylitis With a Percussive Therapy Device

NCT05723809 — Not applicable, Unknown, 66 participants, Cedars-Sinai Medical Center

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Treatment of Lateral Epicondylitis With a Percussive Therapy Device: Outcomes of a Randomized Controlled Trial

RegistryNCT05723809
StatusUnknown
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: single, treatment
Enrollment66 (Estimated)
SponsorCedars-Sinai Medical Center (Other); collaborators: Therabody, Inc.
ConditionsTennis Elbow
InterventionsPercussive Therapy Device, Physical Therapy (Device, behavioral)
Datesstart 2023-03-01 (estimated), primary completion 2023-09-01 (estimated), completion 2023-09-01 (estimated), first posted 2023-02-13, last updated 2023-02-13
Locations1 site in United States

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-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

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+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)

+Arms and interventions

ArmTypeInterventionsDescription
Percussive Therapy DeviceExperimentalDevice: Percussive Therapy Device; Behavioral: Physical TherapyParticipants will be going to physical therapy - 1 session per week for 6 weeks and will use a percussive therapy device daily for 3-7 minutes
Control groupActive comparatorBehavioral: Physical TherapyParticipants will be going to physical therapy - 1 session per week for 6 weeks
  • Percussive Therapy Device (Device), also known as Theragun: Same as group description
  • Physical Therapy (Behavioral): Same as group description

+Outcome measures

Primary outcomes

  • Time to Improvement of Symptoms [3 months]

Secondary outcomes

  • 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
  • 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 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
  • 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

+Eligibility

Sex: All, ages: 18 Years to any

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

+Locations (1)

FacilityCityCountryStatus
Cedars-Sinai Medical CenterLos Angeles, CaliforniaUnited States

+Investigators

My Notes