Lateral EpicondylitisNCT05237869
Blood Flow Restriction & Tennis Elbow Rehab
A study testing Blood Flow Restriction Device and Standard Physical Therapy in people with Lateral Epicondylitis, run by Julie Nuelle at 1 site in United States.
Trial summary
Lateral epicondylitis (LE), often referred to as "tennis elbow" is a common and debilitating overuse injury affecting 1-3% of adults annually. LE is most often defined as a syndrome of pain near the area of the lateral epicondyle of the elbow commonly effecting the origin of the extensor carpi radialis brevis with… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Lateral Epicondylitis
- What is being tested?
- Blood Flow Restriction Device and Standard Physical Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 250 participants
- Where
- 1 siteUnited States
- Study dates
- 20 May 2022to Apr 2027
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ages 18-65 years of age
- Diagnosis of lateral epicondylitis confirmed by the treating orthopaedic surgeon and ultrasound
- Must be able to read and write in English
- Able to provide own written consent
Who cannot join
- Patients over 65 years of age
- Contralateral upper extremity involvement resulting in less than normal range of motion, muscle strength or daily pain greater than 1/10
- History of prior injection for treatment of lateral epicondylitis
- Pregnancy
- Recent history of deep venous thrombosis (within the past 12 months)
- Active treatment with anticoagulants
Show all 13Show fewer
- History of upper quadrant lymph node dissection
- History of endothelial dysfunction
- Patient history of easy bruising
- Active infection in the injured arm
- Cancer
- Uncontrolled peripheral vascular disease
- Uncontrolled diabetes mellitus
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Blood Flow Restricted Training to Enhance Lateral Epicondylitis Rehabilitation.
Lateral epicondylitis (LE), often referred to as "tennis elbow" is a common and debilitating overuse injury affecting 1-3% of adults annually. LE is most often defined as a syndrome of pain near the area of the lateral epicondyle of the elbow commonly effecting the origin of the extensor carpi radialis brevis with associated weakness; it most commonly effects the dominant arm. The best treatment for LE is unknown and research to support current treatment methods are insufficient. A common limitation in functional recovery experienced by this population is pain at the lateral aspect of the elbow. As such, innovative therapeutic interventions directed at quickly reducing pain may address this unmet need and allow for improved outcomes, as well as earlier return to function.
- Conditions
- Lateral Epicondylitis
- Being tested
- Blood Flow Restriction Device, Standard 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.
Blood Flow Restriction DeviceDevice
Occlusion training involves the application of a cuff to the upper arm that is designed to restrict only the low-pressure blood flow in veins. It does not prevent blood flowing from the heart to the arm.
Standard Physical TherapyOther
Standard physical therapy protocol for lateral epicondylitis rehab without blood flow restriction.
| Study group | Role | What they receive |
|---|---|---|
| Physical Therapy | Sham comparator | For patients enrolled in the control group, the participants will undergo calibration of the Delfi Personalized Tourniquet System to measure limb occlusion pressure and will wear the cuff during completion of the exercises with minimal inflation (approximately 5%), to hold the cuff in place during treatment. This will act as a sham. Receives: Other: Standard Physical Therapy |
| Blood Flow Restricted Physical Therapy | Active comparator | Physical therapy assisted by blood flow restriction per standard physical therapy protocol. Receives: Device: Blood Flow Restriction Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Define the effect of BFR training on pain with activity in patients with LE.
Measured on a 0-10 scale by VAS (Visual Analog Scale) patient reported outcome form. The VAS is scored 0-10, and a higher score indicates worse pain/worse outcomes.
Measured: 3 weeks to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2022
- Study start20 May 2022
- Primary completionApr 2027 (estimated)
- Study completionApr 2027 (estimated)
Why it stopped: Barriers to enrollment have been identified, including a lack of insurance coverage for occupational therapy. This study is being temporarily closed until funding can be secured to offset these costs for participants.
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.
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Julie Nuelle
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Julie Nuelle, University of Missouri-Columbia
- Investigators
- Julia Nuelle, MD, Principal investigator, University of Missouri Department of Orthopaedic Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05237869
- Sponsor's protocol ID
- 2070985
- Status last verified
- Jun 2026
- First submitted
- 27 Dec 2021
- Last updated
- 5 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blood Flow Restricted Training to Enhance Lateral Epicondylitis Rehabilitation.
- ClinicalTrials.gov ID
- NCT05237869
- Acronym / sponsor ID
- 2070985
- Conditions
- Lateral Epicondylitis
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Barriers to enrollment have been identified, including a lack of insurance coverage for occupational therapy. This study is being temporarily closed until funding can be secured to offset these costs for participants.
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Julie NuelleUniversity, hospital or other
- Study start
- 20 May 2022 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 14 Feb 2022 (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.
Lateral epicondylitis (LE), often referred to as "tennis elbow" is a common and debilitating overuse injury affecting 1-3% of adults annually. LE is most often defined as a syndrome of pain near the area of the lateral epicondyle of the elbow commonly effecting the origin of the extensor carpi radialis brevis with associated weakness; it most commonly effects the dominant arm. The best treatment for LE is unknown and research to support current treatment methods are insufficient. A common limitation in functional recovery experienced by this population is pain at the lateral aspect of the elbow. As such, innovative therapeutic interventions directed at quickly reducing pain may address this unmet need and allow for improved outcomes, as well as earlier return to function.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physical Therapy | Sham comparator | Other: Standard Physical TherapyFor patients enrolled in the control group, the participants will undergo calibration of the Delfi Personalized Tourniquet System to measure limb occlusion pressure and will wear the cuff during completion of the exercises with minimal inflation (approximately 5%), to hold the cuff in place during treatment. This will act as a sham. |
| Blood Flow Restricted Physical Therapy | Active comparator | Device: Blood Flow Restriction DevicePhysical therapy assisted by blood flow restriction per standard physical therapy protocol. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Ages 18-65 years of age
- Diagnosis of lateral epicondylitis confirmed by the treating orthopaedic surgeon and ultrasound
- Must be able to read and write in English
- Able to provide own written consent
Key exclusion criteria (13 listed)
- Patients over 65 years of age
- Contralateral upper extremity involvement resulting in less than normal range of motion, muscle strength or daily pain greater than 1/10
- History of prior injection for treatment of lateral epicondylitis
- Pregnancy
- Recent history of deep venous thrombosis (within the past 12 months)
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 |
|---|---|---|
| Blood Flow Restriction DeviceOcclusion training involves the application of a cuff to the upper arm that is designed to restrict only the low-pressure blood flow in veins. It does not prevent blood flowing from the heart to the arm. | Device | Blood Flow Restricted Physical Therapy |
| Standard Physical TherapyStandard physical therapy protocol for lateral epicondylitis rehab without blood flow restriction. | Other | Physical Therapy |
Primary outcome
Define the effect of BFR training on pain with activity in patients with LE.
Time frame: 3 weeks to 6 months
Measured on a 0-10 scale by VAS (Visual Analog Scale) patient reported outcome form. The VAS is scored 0-10, and a higher score indicates worse pain/worse outcomes.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2026.
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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.
Julia Nuelle, MD principal investigator
University of Missouri Department of Orthopaedic Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood Flow Restriction Device and Standard Physical Therapy in people with Lateral Epicondylitis, run by Julie Nuelle 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 13 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: paused, as of the sponsor's last update on 5 Jun 2026. 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. Some participants in this study may receive a placebo. 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?
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?
Define the effect of BFR training on pain with activity in patients with LE. (time frame: 3 weeks to 6 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 5 Jun 2026.