Lateral EpicondylitisNCT03234192
Effectiveness of the Astym Technique, the Graston Technique, and Therapeutic Ultrasound in the Treatment of Lateral Epicondylosis.
A study testing Therapeutic ultra sound, Astym Treatment Technique and Graston Treatment Technique in people with Lateral Epicondylitis and Tennis Elbow, run by NYU Langone Health at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lateral Epicondylitis, Tennis Elbow, Posterolateral Rotator Instability
- What is being tested?
- Therapeutic ultra sound, Astym Treatment Technique and Graston Treatment Technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jun 2017to 23 May 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
New York University School of Medicine
New York, New York, 10016
About this study
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.
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.
- Being tested
- Therapeutic ultra sound, Astym Treatment Technique, Graston Treatment Technique
- Keywords
- extensor carpi radialis brevis, Therapeutic Ultrasound, Astym Treatment Technique, Graston Treatment Technique
- Medical subject headings
- Tennis Elbow
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapeutic ultra soundProcedure or surgery
This group will receive standard treatment consisting of eccentric strengthening, stretch, proximal strengthening, and education in addition to therapeutic ultra sound treatment.
Astym Treatment TechniqueProcedure or surgery
This group will receive standard treatment consisting of eccentric strengthening, stretch, proximal strengthening, and education in addition to Astym Treatment.
Graston Treatment TechniqueProcedure or surgery
This group will receive standard treatment consisting of eccentric strengthening, stretch, proximal strengthening, and education in addition to Graston Treatment.
| Study group | Role | What they receive |
|---|---|---|
| Therapeutic ultra sound | Active comparator | Not described Receives: Procedure: Therapeutic ultra sound |
| Astym Treatment Technique | Active comparator | Not described Receives: Procedure: Astym Treatment Technique |
| Graston Treatment Technique | Active comparator | Not described Receives: Procedure: Graston Treatment Technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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"
Measured: 30 Minutes
Secondary outcomes (6)
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.
Measured: 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
Measured: 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
Measured: 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
Measured: 30 Minutes
Cozens Test
This involves the examiner resisting the wrist extension force of the client with the elbow in extension
Measured: 30 Minutes
Mills Test
This is performed by palpating the lateral epicondyle while passively pronating the forearm, flexing the wrist, and extending the elbow
Measured: 30 Minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2017
- Study start10 Jun 2017
- Primary completion23 May 2019
- Study completion23 May 2019
Why it stopped: Recruiting was halted due to methodology issues
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lateral EpicondylitisStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Steve Vanlew, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03234192
- Sponsor's protocol ID
- 16-02176
- Status last verified
- Jan 2020
- First submitted
- 26 Jul 2017
- Last updated
- 18 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All of the individual participant data collected during the trial, after deidentification.
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT03234192
- Acronym / sponsor ID
- 16-02176
- Keywords
- extensor carpi radialis brevis, Therapeutic Ultrasound, Astym Treatment Technique, Graston Treatment Technique
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruiting was halted due to methodology issues
- Enrolment
- 21 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 10 Jun 2017 (actual)
- Primary completion
- 23 May 2019 (actual)
- Study completion
- 23 May 2019 (actual)
- First posted
- 31 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Therapeutic ultra soundThis group will receive standard treatment consisting of eccentric strengthening, stretch, proximal strengthening, and education in addition to therapeutic ultra sound treatment. | Procedure or surgery | Therapeutic ultra sound |
| Astym Treatment TechniqueThis group will receive standard treatment consisting of eccentric strengthening, stretch, proximal strengthening, and education in addition to Astym Treatment. | Procedure or surgery | Astym Treatment Technique |
| Graston Treatment TechniqueThis group will receive standard treatment consisting of eccentric strengthening, stretch, proximal strengthening, and education in addition to Graston Treatment. | Procedure or surgery | Graston Treatment Technique |
Primary outcome
Patient Rated Tennis Elbow Evaluation (PRTEE)
Time frame: 30 Minutes
This is a 15 item self-reported questionnaire to measure perceived pain and disability in people with Lateral Epicondylosis (LE)
QuickDASH
Time frame: 30 Minutes
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"
6 secondary outcomes
EQ-5D-5L
Time frame: 30 Minutes
Range of motion
Time frame: 30 Minutes
Grip strength
Time frame: 30 Minutes
Numeric Rating Scale for Pain
Time frame: 30 Minutes
Cozens Test
Time frame: 30 Minutes
Mills Test
Time frame: 30 Minutes
Results and safety
The study was stopped early (reason given: Recruiting was halted due to methodology issues). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2020.
- Individual participant dataSharing planned: Yes. All of the individual participant data collected during the trial, after deidentification.
Related trials for Lateral Epicondylitis
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Effect of Ultrasound-Guided Posterior Cutaneous Nerve of the Forearm Epicondylar Branch Block on Pain and Function in Lateral Epicondylitis (PCNF-BrEpi)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steve Vanlew, MD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Therapeutic ultra sound, Astym Treatment Technique and Graston Treatment Technique in people with Lateral Epicondylitis and Tennis Elbow, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 18 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Recruiting was halted due to methodology issues). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Rated Tennis Elbow Evaluation (PRTEE) (time frame: 30 Minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2020.