Back to resultsEffectiveness of the Astym Technique, the Graston Technique, and Therapeutic Ultrasound in the Treatment of Lateral Epicondylosis.
Primary Purpose
Lateral Epicondylitis, Tennis Elbow, Posterolateral Rotator Instability
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Therapeutic ultra sound
Astym Treatment Technique
Graston Treatment Technique
Sponsored by
About this trial
This is an interventional treatment trial for Lateral Epicondylitis focused on measuring extensor carpi radialis brevis, Therapeutic Ultrasound, Astym Treatment Technique, Graston Treatment Technique
Eligibility Criteria
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.
Sites / Locations
- New York University School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Therapeutic ultra sound
Astym Treatment Technique
Graston Treatment Technique
Arm Description
Outcomes
Primary Outcome Measures
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)
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"
Secondary Outcome Measures
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.
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
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
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
Cozens Test
This involves the examiner resisting the wrist extension force of the client with the elbow in extension
Mills Test
This is performed by palpating the lateral epicondyle while passively pronating the forearm, flexing the wrist, and extending the elbow
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03234192
Brief Title
Effectiveness of the Astym Technique, the Graston Technique, and Therapeutic Ultrasound in the Treatment of Lateral Epicondylosis.
Official Title
A Randomized Clinical Controlled Study Comparing the Effectiveness of the Astym Technique, the Graston Technique, and Therapeutic Ultrasound in the Treatment of Lateral Epicondylosis.
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Terminated
Why Stopped
Recruiting was halted due to methodology issues
Study Start Date
June 10, 2017 (Actual)
Primary Completion Date
May 23, 2019 (Actual)
Study Completion Date
May 23, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lateral Epicondylitis, Tennis Elbow, Posterolateral Rotator Instability
Keywords
extensor carpi radialis brevis, Therapeutic Ultrasound, Astym Treatment Technique, Graston Treatment Technique
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Randomized
Enrollment
21 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Therapeutic ultra sound
Arm Type
Active Comparator
Arm Title
Astym Treatment Technique
Arm Type
Active Comparator
Arm Title
Graston Treatment Technique
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Therapeutic ultra sound
Intervention Description
This group will receive standard treatment consisting of eccentric strengthening, stretch, proximal strengthening, and education in addition to therapeutic ultra sound treatment.
Intervention Type
Procedure
Intervention Name(s)
Astym Treatment Technique
Intervention Description
This group will receive standard treatment consisting of eccentric strengthening, stretch, proximal strengthening, and education in addition to Astym Treatment.
Intervention Type
Procedure
Intervention Name(s)
Graston Treatment Technique
Intervention Description
This group will receive standard treatment consisting of eccentric strengthening, stretch, proximal strengthening, and education in addition to Graston Treatment.
Primary Outcome Measure Information:
Title
Patient Rated Tennis Elbow Evaluation (PRTEE)
Description
This is a 15 item self-reported questionnaire to measure perceived pain and disability in people with Lateral Epicondylosis (LE)
Time Frame
30 Minutes
Title
QuickDASH
Description
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"
Time Frame
30 Minutes
Secondary Outcome Measure Information:
Title
EQ-5D-5L
Description
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.
Time Frame
30 Minutes
Title
Range of motion
Description
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
Time Frame
30 Minutes
Title
Grip strength
Description
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
Time Frame
30 Minutes
Title
Numeric Rating Scale for Pain
Description
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
Time Frame
30 Minutes
Title
Cozens Test
Description
This involves the examiner resisting the wrist extension force of the client with the elbow in extension
Time Frame
30 Minutes
Title
Mills Test
Description
This is performed by palpating the lateral epicondyle while passively pronating the forearm, flexing the wrist, and extending the elbow
Time Frame
30 Minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steve Vanlew, MD
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York University School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
Learn more about this trial
Effectiveness of the Astym Technique, the Graston Technique, and Therapeutic Ultrasound in the Treatment of Lateral Epicondylosis.
We'll reach out to this number within 24 hrs