Effectiveness of the Astym Technique, the Graston Technique, and Therapeutic Ultrasound in the Treatment of Lateral Epicondylosis.

A Randomized Clinical Controlled Study Comparing the Effectiveness of the Astym Technique, the Graston Technique, and Therapeutic Ultrasound in the Treatment of Lateral Epicondylosis.

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.

Study Overview

• Status: Terminated
• Conditions: Lateral Epicondylitis; Tennis Elbow; Posterolateral Rotator Instability
• Intervention / Treatment: Procedure: Therapeutic ultra sound; Procedure: Astym Treatment Technique; Procedure: Graston Treatment Technique

• Study Type: Interventional
• Enrollment (Actual): 21
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • New York University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: SINGLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Therapeutic ultra sound	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.
ACTIVE_COMPARATOR: Astym Treatment Technique	Procedure: Astym Treatment Technique; This group will receive standard treatment consisting of eccentric strengthening, stretch, proximal strengthening, and education in addition to Astym Treatment.
ACTIVE_COMPARATOR: Graston Treatment Technique	Procedure: Graston Treatment Technique; This group will receive standard treatment consisting of eccentric strengthening, stretch, proximal strengthening, and education in addition to Graston Treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
Cozens Test	This involves the examiner resisting the wrist extension force of the client with the elbow in extension	30 Minutes
Mills Test	This is performed by palpating the lateral epicondyle while passively pronating the forearm, flexing the wrist, and extending the elbow	30 Minutes

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: Steve Vanlew, MD, NYU Langone Health

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 10, 2017
• Primary Completion (ACTUAL): May 23, 2019
• Study Completion (ACTUAL): May 23, 2019

Study Registration Dates

• First Submitted: July 26, 2017
• First Submitted That Met QC Criteria: July 26, 2017
• First Posted (ACTUAL): July 31, 2017

Study Record Updates

• Last Update Posted (ACTUAL): January 18, 2020
• Last Update Submitted That Met QC Criteria: January 15, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: Therapeutic Ultrasound; extensor carpi radialis brevis; Astym Treatment Technique; Graston Treatment Technique
• Additional Relevant MeSH Terms: Wounds and Injuries; Musculoskeletal Diseases; Muscular Diseases; Tendon Injuries; Tendinopathy; Arm Injuries; Elbow Tendinopathy; Tennis Elbow
• Other Study ID Numbers: 16-02176

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All of the individual participant data collected during the trial, after deidentification.
• IPD Sharing Time Frame: Immediately following publication. No end date.
• IPD Sharing Access Criteria: Anyone who wishes to access the data.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No