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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03234192
Other study ID # 16-02176
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date June 10, 2017
Est. completion date May 23, 2019

Study information

Verified date January 2020
Source NYU Langone Health
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Terminated
Enrollment 21
Est. completion date May 23, 2019
Est. primary completion date May 23, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- 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

Exclusion Criteria:

- 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.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Therapeutic ultra sound
This group will receive standard treatment consisting of eccentric strengthening, stretch, proximal strengthening, and education in addition to therapeutic ultra sound treatment.
Astym Treatment Technique
This group will receive standard treatment consisting of eccentric strengthening, stretch, proximal strengthening, and education in addition to Astym Treatment.
Graston Treatment Technique
This group will receive standard treatment consisting of eccentric strengthening, stretch, proximal strengthening, and education in addition to Graston Treatment.

Locations

Country Name City State
United States New York University School of Medicine New York New York

Sponsors (1)

Lead Sponsor Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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 EQ-5D-5L This is a visual analog scale used to assess the clients view of their overall health on a scale of 0 (worst imaginable) to 100 (best imaginable). Also, clients report issues with mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each is scored on a 3 point scale. 30 Minutes
Secondary Range of motion This will be taken at the wrist and elbow using goniometric measurements and a volar/dorsal approach at the wrist and lateral approach at the elbow. Measurements recorded will be wrist flexion and extension and elbow flexion and extension 30 Minutes
Secondary Grip strength This will be measured using a hand held dynamometer and tested in the standard (arm at side) position and elbow extension position. Three trials on each UE will be reported in pounds 30 Minutes
Secondary Numeric Rating Scale for Pain This scale is a single point scale from 0-10. The client picks one number to represent their pain, where 0 represents no pain and 10 represents worst pain imaginable 30 Minutes
Secondary Cozens Test This involves the examiner resisting the wrist extension force of the client with the elbow in extension 30 Minutes
Secondary Mills Test This is performed by palpating the lateral epicondyle while passively pronating the forearm, flexing the wrist, and extending the elbow 30 Minutes
See also
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