NCT03234192

Brief Summary

The purpose of this study is to examine the effectiveness of three common techniques for the treatment of lateral epicondylosis. Through objective and subjective assessments this study will determine the effectiveness of the Astym Treatment Technique, the Graston Treatment Technique, and therapeutic ultrasound in the conservative treatment of lateral epicondylosis. It is hypothesized that the more manual Astym technique and Graston technique will produce more significant results than the more frequently utilized ultrasound.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 10, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 26, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 31, 2017

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 23, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 23, 2019

Completed
Last Updated

January 18, 2020

Status Verified

January 1, 2020

Enrollment Period

2 years

First QC Date

July 26, 2017

Last Update Submit

January 15, 2020

Conditions

Lateral EpicondylitisTennis ElbowPosterolateral Rotator Instability

Keywords

extensor carpi radialis brevisTherapeutic UltrasoundAstym Treatment TechniqueGraston Treatment Technique

Outcome Measures

Primary Outcomes (2)

  • Patient Rated Tennis Elbow Evaluation (PRTEE)

    This is a 15 item self-reported questionnaire to measure perceived pain and disability in people with Lateral Epicondylosis (LE)

    30 Minutes

  • QuickDASH

    This is an 11 item questionnaire where by participants' score themselves using a 1-5 point scale. 1 represents "no difficulty" in performing task whereas 5 represents "unable to perform task"

    30 Minutes

Secondary Outcomes (6)

  • EQ-5D-5L

    30 Minutes

  • Range of motion

    30 Minutes

  • Grip strength

    30 Minutes

  • Numeric Rating Scale for Pain

    30 Minutes

  • Cozens Test

    30 Minutes

  • +1 more secondary outcomes

Study Arms (3)

Therapeutic ultra sound

ACTIVE COMPARATOR
Procedure: Therapeutic ultra sound

Astym Treatment Technique

ACTIVE COMPARATOR
Procedure: Astym Treatment Technique

Graston Treatment Technique

ACTIVE COMPARATOR
Procedure: Graston Treatment Technique

Interventions

Therapeutic ultra soundPROCEDURE

This group will receive standard treatment consisting of eccentric strengthening, stretch, proximal strengthening, and education in addition to therapeutic ultra sound treatment.

Therapeutic ultra sound
Astym Treatment TechniquePROCEDURE

This group will receive standard treatment consisting of eccentric strengthening, stretch, proximal strengthening, and education in addition to Astym Treatment.

Astym Treatment Technique
Graston Treatment TechniquePROCEDURE

This group will receive standard treatment consisting of eccentric strengthening, stretch, proximal strengthening, and education in addition to Graston Treatment.

Graston Treatment Technique

Eligibility Criteria

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

You may qualify if:

  • Clients who are admitted to NYULMC Center for Musculoskeletal Care for outpatient occupational or physical therapy with a diagnosis of lateral epicondylosis will be included. To participate in the study participants must:
  • Be able to follow a home exercise program
  • Be able to consent to participation in the research study

You may not qualify if:

  • Clients who are deemed unable to consent to participation in the research study and/or unable to following a home exercise program will not be included in this study
  • Clients with additional acute orthopedic injuries and/or surgeries to the involved upper extremity will not be included in this study.
  • Clients with open wounds of the involved upper extremity that will interfere with treatment techniques will not be involved in this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New York University School of Medicine

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Tennis Elbow

Condition Hierarchy (Ancestors)

Elbow TendinopathyTendinopathyMuscular DiseasesMusculoskeletal DiseasesElbow InjuriesArm InjuriesWounds and InjuriesTendon Injuries

Study Officials

  • Steve Vanlew, MD

    NYU Langone Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 26, 2017

First Posted

July 31, 2017

Study Start

June 10, 2017

Primary Completion

May 23, 2019

Study Completion

May 23, 2019

Last Updated

January 18, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will share

All of the individual participant data collected during the trial, after deidentification.

Shared Documents
STUDY PROTOCOL
Time Frame
Immediately following publication. No end date.
Access Criteria
Anyone who wishes to access the data.

Locations

US(1)