Tennis ElbowNCT05723809
Treatment of Lateral Epicondylitis With a Percussive Therapy Device
A study testing Percussive Therapy Device and Physical Therapy in people with Tennis Elbow, run by Cedars-Sinai Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to assess the efficacy of using a percussive therapy device in addition to physical therapy to treat acute tennis elbow Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tennis Elbow
- What is being tested?
- Percussive Therapy Device and Physical Therapy
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2023to 1 Sep 2023
- 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
- Individuals 18 years old or older are included
- Patients with atraumatic lateral epicondylitis symptoms
- Symptoms persistent and present for at least 2 weeks
- Presence of 2 of the following on clinical examination: +tenderness to palpation common extensor tendons and/or lateral epicondyle origin, pain over the lateral elbow with passive flexion of the wrist in an extended position, +pain with resisted supination, +pain with resisted middle finger extension.
Who cannot join
- Any records flagged "break the glass" or "research opt out."
- Patients with elbow osteoarthritis,
- Patients with a history of traumatic injury to the elbow
- Patients with workers compensation
- Patients who received cortisol injection in the elbow
- MRI evidence of common extensor tear
Show all 11Show fewer
- A history of surgery on the affected elbow,
- Cognitive or behavioral problems which would preclude informed consent.
- Patients with coagulopathies
- Patients who are pregnant
- Patients who had a cortisone injection within 3 months
Trial locations and contacts
1 site in 1 country.
United States1 site
Cedars-Sinai Medical Center
Los Angeles, California, 90048
Michael A Stone, M.D, 310-423-4566
About this study
Official title: Treatment of Lateral Epicondylitis With a Percussive Therapy Device: Outcomes of a Randomized Controlled Trial
The purpose of this study is to assess the efficacy of using a percussive therapy device in addition to physical therapy to treat acute tennis elbow
Read the detailed description
The device the investigators intend to use is Class I and in a class of devices that is exempt from the FDA requirement for premarket notification/approval (exempt from 510K or PMA), which would not be "subject to section 510(k), 515, or 520(m) of the Federal Food, Drug, and Cosmetic Act" (ref: FDAAA Checklist)
- Conditions
- Tennis Elbow
- Being tested
- Percussive Therapy Device, Physical Therapy
- Medical subject headings
- Tennis Elbow
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percussive Therapy DeviceDevice
Also called Theragun
Same as group description
Physical TherapyBehavioural
Same as group description
| Study group | Role | What they receive |
|---|---|---|
| Percussive Therapy Device | Experimental | Participants will be going to physical therapy - 1 session per week for 6 weeks and will use a percussive therapy device daily for 3-7 minutes Receives: Device: Percussive Therapy Device; Behavioral: Physical Therapy |
| Control group | Active comparator | Participants will be going to physical therapy - 1 session per week for 6 weeks Receives: Behavioral: Physical Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Improvement of Symptoms
Measured: 3 months
Secondary outcomes (6)
PROMIS Upper Extremity
Patient-Reported Outcomes Measurement Information System
Upper extremity - 0-100 indicating functionality of the upper extremity with higher scores representing more functionality
Measured: 3 months
PROMIS Physical Functioning
Patient-Reported Outcomes Measurement Information System
Physical function 0-100 indicating overall functionality with higher scores representing more functionality
Measured: 3 months
PROMIS Pain Interference
Patient-Reported Outcomes Measurement Information System
Pain interference 0-100 measures the extent to which pain hinders an individual's engagement with physical, mental, cognitive, emotional, recreational, and social activities with higher scores representing more interference
Measured: 3 months
PROMIS Depression
Patient-Reported Outcomes Measurement Information System
Depression - 0-100 assess self-reported negative mood (sadness, guilt), views of self (self- criticism, worthlessness), and social cognition (loneliness, interpersonal alienation), as well as decreased positive affect and engagement (loss of interest, meaning, and purpose) with higher scores indicating more depression
Measured: 3 months
VAS pain score
Visual Analog Score for pain - subjective measure for acute and chronic pain. Scaled 0-10
Measured: 3 months
SANE score
Single Assessment Numeric Evaluation - This is a single-question outcome measure that asks patients to rate their function, as it pertains to the area being treated, on a scale of 0 to 100
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2023
- Study start1 Mar 2023 (estimated)
- Primary completion1 Sep 2023 (estimated)
- Study completion1 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tennis ElbowStudies of the same condition, open and under way.
- More trials run by Cedars-Sinai Medical CenterThe 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cedars-Sinai Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Therabody, Inc.
- Responsible party
- Principal investigator, Michael Stone, Cedars-Sinai Medical Center
- Investigators
- Michael A Stone, M.D, Principal investigator, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05723809
- Sponsor's protocol ID
- STUDY00002285
- Status last verified
- Feb 2023
- First submitted
- 30 Jan 2023
- Last updated
- 13 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Lateral Epicondylitis With a Percussive Therapy Device: Outcomes of a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05723809
- Acronym / sponsor ID
- STUDY00002285
- Conditions
- Tennis Elbow
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Cedars-Sinai Medical CenterUniversity, hospital or other
- Collaborators
- Therabody, Inc.
- Study start
- 1 Mar 2023 (estimated)
- Primary completion
- 1 Sep 2023 (estimated)
- Study completion
- 1 Sep 2023 (estimated)
- First posted
- 13 Feb 2023 (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 assess the efficacy of using a percussive therapy device in addition to physical therapy to treat acute tennis elbow
Detailed description
The device the investigators intend to use is Class I and in a class of devices that is exempt from the FDA requirement for premarket notification/approval (exempt from 510K or PMA), which would not be "subject to section 510(k), 515, or 520(m) of the Federal Food, Drug, and Cosmetic Act" (ref: FDAAA Checklist)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Percussive Therapy Device | Experimental | Device: Percussive Therapy Device, Behavioral: Physical TherapyParticipants will be going to physical therapy - 1 session per week for 6 weeks and will use a percussive therapy device daily for 3-7 minutes |
| Control group | Active comparator | Behavioral: Physical TherapyParticipants will be going to physical therapy - 1 session per week for 6 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Individuals 18 years old or older are included
- Patients with atraumatic lateral epicondylitis symptoms
- Symptoms persistent and present for at least 2 weeks
- Presence of 2 of the following on clinical examination: +tenderness to palpation common extensor tendons and/or lateral epicondyle origin, pain over the lateral elbow with passive flexion of the wrist in an extended position, +pain with resisted supination, +pain with resisted middle finger extension.
Key exclusion criteria (11 listed)
- Any records flagged "break the glass" or "research opt out."
- Patients with elbow osteoarthritis,
- Patients with a history of traumatic injury to the elbow
- Patients with workers compensation
- Patients who received cortisol injection in the elbow
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 |
|---|---|---|
| Percussive Therapy DeviceAlso: TheragunSame as group description | Device | Percussive Therapy Device |
| Physical TherapySame as group description | Behavioural | Control group, Percussive Therapy Device |
Primary outcome
Time to Improvement of Symptoms
Time frame: 3 months
6 secondary outcomes
PROMIS Upper Extremity
Time frame: 3 months
PROMIS Physical Functioning
Time frame: 3 months
PROMIS Pain Interference
Time frame: 3 months
PROMIS Depression
Time frame: 3 months
VAS pain score
Time frame: 3 months
SANE score
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2023.
- Individual participant dataSharing planned: No
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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.
Michael A Stone, M.D principal investigator
Cedars-Sinai Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Percussive Therapy Device and Physical Therapy in people with Tennis Elbow, run by Cedars-Sinai Medical Center 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 4 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 13 Feb 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Joshua Langberg, B.A (8184423333, joshua.langberg@cshs.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Improvement of Symptoms (time frame: 3 months). 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 13 Feb 2023; AzTrials last refreshed its copy on 6 Nov 2026.