Treatment of Lateral Epicondylitis With a Percussive Ther... | NCT05723809

Studies
Treatment of Lateral Epicondylitis With a Percussive Therapy Device

NCT05723809

Sponsor

Cedars-Sinai Medical Center

Status

Unknown status

Last Update Posted

Feb 13, 2023Actual

Enrollment

66Estimated

Phase

Not Applicable

Conditions

Tennis Elbow

Interventions

Percussive Therapy Device
Physical Therapy

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 1, 2023Estimated

Primary Completion Date

Sep 1, 2023Estimated

Completion Date

Sep 1, 2023Estimated

First Submitted Date

Jan 30, 2023

First Submission Date that Met QC Criteria

Feb 9, 2023

First Posted Date

Feb 13, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 9, 2023

Last Update Posted Date

Feb 13, 2023Actual

Name	Class
Therabody, Inc.	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

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)

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

66Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Percussive Therapy Device	Experimental	Participants 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	Device: Percussive Therapy Device Behavioral: Physical Therapy
Control group	Active Comparator	Participants will be going to physical therapy - 1 session per week for 6 weeks	Behavioral: Physical Therapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Percussive Therapy Device	Device	Same as group description	Percussive Therapy Device

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Time to Improvement of Symptoms		3 months

Secondary Outcomes

Measure	Description	Time Frame
PROMIS Upper Extremity	Patient-Reported Outcomes Measurement Information System Upper extremity - 0-100 indicating functionality of the upper extremity with higher scores representing more functionality	3 months
PROMIS Physical Functioning

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Joshua Langberg, B.A	Contact	8184423333		joshua.langberg@cshs.org

Overall Officials

Name	Affiliation	Role
Michael A Stone, M.D	Cedars-Sinai Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Cedars-Sinai Medical Center		Los Angeles	California	90048	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D013716	Tennis Elbow

Ancestor Terms

ID	Term
D000070639	Elbow Tendinopathy
D052256	Tendinopathy
D009135	Muscular Diseases
D009140	Musculoskeletal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

ID	Term
D013812	Therapeutics
D012046	Rehabilitation