NCT05723809

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 30, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 13, 2023

Completed
16 days until next milestone

Study Start

First participant enrolled

March 1, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2023

Completed
Last Updated

February 13, 2023

Status Verified

February 1, 2023

Enrollment Period

6 months

First QC Date

January 30, 2023

Last Update Submit

February 9, 2023

Conditions

Tennis Elbow

Outcome Measures

Primary Outcomes (1)

  • Time to Improvement of Symptoms

    3 months

Secondary Outcomes (6)

  • PROMIS Upper Extremity

    3 months

  • PROMIS Physical Functioning

    3 months

  • PROMIS Pain Interference

    3 months

  • PROMIS Depression

    3 months

  • VAS pain score

    3 months

  • +1 more secondary outcomes

Study Arms (2)

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 DeviceBehavioral: Physical Therapy

Control group

ACTIVE COMPARATOR

Participants will be going to physical therapy - 1 session per week for 6 weeks

Behavioral: Physical Therapy

Interventions

Percussive Therapy DeviceDEVICE

Same as group description

Also known as: Theragun
Percussive Therapy Device
Physical TherapyBEHAVIORAL

Same as group description

Control groupPercussive Therapy Device

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

MeSH Terms

Conditions

Tennis Elbow

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Elbow TendinopathyTendinopathyMuscular DiseasesMusculoskeletal DiseasesElbow InjuriesArm InjuriesWounds and InjuriesTendon Injuries

Intervention Hierarchy (Ancestors)

TherapeuticsRehabilitation

Study Officials

  • Michael A Stone, M.D

    Cedars-Sinai Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Joshua Langberg, B.A

CONTACT

8184423333joshua.langberg@cshs.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, Assistant Professor, Orthopedic Surgeon

Study Record Dates

First Submitted

January 30, 2023

First Posted

February 13, 2023

Study Start

March 1, 2023

Primary Completion

September 1, 2023

Study Completion

September 1, 2023

Last Updated

February 13, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)