Lateral EpicondylitisNCT03978897
Trial of Blood Flow Restriction Plus Physical Therapy vs. Physical Therapy Alone for Lateral Epicondylitis
A study testing Blood flow restriction tourniquet and Evidence based physical/occupational therapy in people with Lateral Epicondylitis, run by Cleveland Clinic Akron General at 1 site in United States.
Trial summary
Open label randomized controlled trial comparing evidenced based physical/occupational therapy vs. physical/occupational therapy including blood flow restriction tourniquet in the treatment of lateral epicondylitis (tennis elbow). Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Lateral Epicondylitis
- What is being tested?
- Blood flow restriction tourniquet and Evidence based physical/occupational therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2019to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The diagnoses included are lateral elbow pain, lateral epicondylitis, or lateral epicondylalgia, more general diagnoses elbow tendinitis or elbow pain will be included if their clinical picture at physical therapy meets criteria for lateral epicondylitis.
- If the inclusion diagnosis is other than lateral epicondylitis or tennis elbow (such as elbow pain), we will confirm the diagnosis at the first therapy visit with tenderness at the lateral epicondyle and/or pain with resisted wrist/long finger extension at the lateral epicondyle.
- Pain for 4 weeks or more.
- All participants must be between the age of 18 and 70 years old and have had pain for 4 weeks or more.
Who cannot join
- Ligamentous elbow sprain, osteoarthritis of elbow and cervical radiculopathy in the affected limb will be excluded from the study.
- Any history of ligamentous, bony or other soft tissue reconstruction surgery at the affected elbow,
- Vascular disorders to include: history of DVT, history of endothelial dysfunction, peripheral vascular disease
- Injection therapy (corticosteroid, platelet rich plasma, or other injection therapy) in the prior 3 months to the affected site
- Current fracture in affected arm
- History of crush injury to affected arm
Show all 16Show fewer
- Any surgery on affected arm in last 1 year
- Surgical procedure on their contralateral extremity (Changed 9/2019 to surgery within last year on contralateral upper extremity).
- History of lymphectomy (such as axillary exploration with breast surgery, lymph node biopsy in the affected axilla/arm)
- Pregnancy
- Active infection
- Current cancer diagnosis/treatment
- Sickle cell anemia or trait
- Kidney dialysis
- History of syncope/passing out with pressure to body (such as massage, or blood pressure cuff).
- inability to consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Trial of Blood Flow Restriction Plus Conventional Physical Therapy vs. Conventional Physical Therapy Alone in the Treatment of Lateral Epicondylitis
Open label randomized controlled trial comparing evidenced based physical/occupational therapy vs. physical/occupational therapy including blood flow restriction tourniquet in the treatment of lateral epicondylitis (tennis elbow).
Read the detailed description
Patients will be randomized to one of two groups, and treatment will be open label and unblinded. A target of 44 patients for enrollment has been set for 80% power, actual enrollment resulted in 41 patients undergoing randomization. Treatment will last for 6 visits with physical therapy with recommended visit intervals of 1 week :
Intervention Group: Evidence based physical/occupational therapy, with the addition of therapeutic exercises using a blood flow restriction tourniquet.
Control Group: Patients will receive standard evidence based physical therapy
The primary outcome (Patient-Rated Tennis Elbow Evaluation [PRTEE]) will be collected at enrollment, 3, 6, and 12 months.
Secondary outcomes will be collected at the beginning and end of physical therapy interventions (change in: numeric pain rating scale, maximum pain free grip strength, pain free grip strength). We will collect treatments received after the end of physical therapy and before final follow up.
- Conditions
- Lateral Epicondylitis
- Being tested
- Blood flow restriction tourniquet, Evidence based physical/occupational therapy
- Keywords
- lateral epicondylitis, tennis elbow, blood flow restriction, 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 tourniquetDevice
Also called Delfi personalized tourniquet system
A blood flow restriction tourniquet, which impedes arterial flow to extremity at 50% of usual flow.
Evidence based physical/occupational therapyOther
Up to date physical/occupational therapy for lateral epicondylitis
| Study group | Role | What they receive |
|---|---|---|
| Blood flow restriction with physical/occupational therapy | Experimental | physical/occupational therapy including use of blood flow restriction tourniquet over 6 visits (within a twelve week period). Receives: Device: Blood flow restriction tourniquet |
| Evidence based physical/occupational therapy | Active comparator | evidence based physical/occupational therapy program over 6 visits (within a twelve week period) without use of blood flow restriction tourniquet Receives: Other: Evidence based physical/occupational therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Patient Rated Tennis Elbow Evaluation (PRTEE)
Change in score on 'Patient rated tennis elbow evaluation' total score from baseline to 12 month final follow up. Lower numbers suggest less pain, higher scores suggest more pain. Total score 0-100.
Includes pain subscale (0-50)
Specific activities subscale (0-60)
Usual activities subscale (0-40)
Function Subscale= (specific activities score + usual activities score)/2 (0-50)
Total Score= Pain subscale + Function Subscale (0-100)
Measured: 12 months
Secondary outcomes (4)
Numeric Pain Rating Scale
change in score from baseline to final 12 month follow up on 0-10 pain rating scale with 0 being no pain, and 10 being worst pain.
Measured: 12 months
Pain Free Grip Strength
Change in pain free grip strength (kg) on dynamometer from baseline to final PT visit (approximately 12 weeks)
Measured: at final therapy visit up to 12 weeks after enrollment
Maximum Grip Strength
Change in maximum grip strength (kg) on dynamometer from baseline visit to final PT visit (approximately 12 weeks)
Measured: at final therapy visit up to 12 weeks after enrollment
Other Treatments Received
We will collect data on whether the patient sought or received treatments beyond physical/occupational therapy over the 12 months of enrollment in the study
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2019
- Study start1 Jul 2019
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cleveland Clinic Akron General
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aaron Lear, Cleveland Clinic Akron General
- Investigators
- Aaron Lear, MD, CAQ, Principal investigator, Cleveland Clinic Akron General
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03978897
- Sponsor's protocol ID
- 19001
- Status last verified
- Apr 2026
- First submitted
- 24 May 2019
- Last updated
- 5 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Blood Flow Restriction Plus Conventional Physical Therapy vs. Conventional Physical Therapy Alone in the Treatment of Lateral Epicondylitis
- ClinicalTrials.gov ID
- NCT03978897
- Acronym / sponsor ID
- 19001
- Conditions
- Lateral Epicondylitis
- Keywords
- lateral epicondylitis, tennis elbow, blood flow restriction, physical therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Cleveland Clinic Akron GeneralUniversity, hospital or other
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 7 Jun 2019 (actual)
- Results
- Posted 5 May 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Open label randomized controlled trial comparing evidenced based physical/occupational therapy vs. physical/occupational therapy including blood flow restriction tourniquet in the treatment of lateral epicondylitis (tennis elbow).
Detailed description
Patients will be randomized to one of two groups, and treatment will be open label and unblinded. A target of 44 patients for enrollment has been set for 80% power, actual enrollment resulted in 41 patients undergoing randomization. Treatment will last for 6 visits with physical therapy with recommended visit intervals of 1 week :
Intervention Group: Evidence based physical/occupational therapy, with the addition of therapeutic exercises using a blood flow restriction tourniquet.
Control Group: Patients will receive standard evidence based physical therapy
The primary outcome (Patient-Rated Tennis Elbow Evaluation [PRTEE]) will be collected at enrollment, 3, 6, and 12 months.
Secondary outcomes will be collected at the beginning and end of physical therapy interventions (change in: numeric pain rating scale, maximum pain free grip strength, pain free grip strength). We will collect treatments received after the end of physical therapy and before final follow up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Blood flow restriction with physical/occupational therapy | Experimental | Device: Blood flow restriction tourniquetphysical/occupational therapy including use of blood flow restriction tourniquet over 6 visits (within a twelve week period). |
| Evidence based physical/occupational therapy | Active comparator | Other: Evidence based physical/occupational therapyevidence based physical/occupational therapy program over 6 visits (within a twelve week period) without use of blood flow restriction tourniquet |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- The diagnoses included are lateral elbow pain, lateral epicondylitis, or lateral epicondylalgia, more general diagnoses elbow tendinitis or elbow pain will be included if their clinical picture at physical therapy meets criteria for lateral epicondylitis.
- If the inclusion diagnosis is other than lateral epicondylitis or tennis elbow (such as elbow pain), we will confirm the diagnosis at the first therapy visit with tenderness at the lateral epicondyle and/or pain with resisted wrist/long finger extension at the lateral epicondyle.
- Pain for 4 weeks or more.
- All participants must be between the age of 18 and 70 years old and have had pain for 4 weeks or more.
Key exclusion criteria (16 listed)
- Ligamentous elbow sprain, osteoarthritis of elbow and cervical radiculopathy in the affected limb will be excluded from the study.
- Any history of ligamentous, bony or other soft tissue reconstruction surgery at the affected elbow,
- Vascular disorders to include: history of DVT, history of endothelial dysfunction, peripheral vascular disease
- Injection therapy (corticosteroid, platelet rich plasma, or other injection therapy) in the prior 3 months to the affected site
- Current fracture in affected arm
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 tourniquetAlso: Delfi personalized tourniquet systemA blood flow restriction tourniquet, which impedes arterial flow to extremity at 50% of usual flow. | Device | Blood flow restriction with physical/occupational therapy |
| Evidence based physical/occupational therapyUp to date physical/occupational therapy for lateral epicondylitis | Other | Evidence based physical/occupational therapy |
Primary outcome
Change in Patient Rated Tennis Elbow Evaluation (PRTEE)
Time frame: 12 months
Change in score on 'Patient rated tennis elbow evaluation' total score from baseline to 12 month final follow up. Lower numbers suggest less pain, higher scores suggest more pain. Total score 0-100. Includes pain subscale (0-50) Specific activities subscale (0-60) Usual activities subscale (0-40) Function Subscale= (specific activities score + usual activities score)/2 (0-50) Total Score= Pain subscale + Function Subscale (0-100)
4 secondary outcomes
Numeric Pain Rating Scale
Time frame: 12 months
Pain Free Grip Strength
Time frame: at final therapy visit up to 12 weeks after enrollment
Maximum Grip Strength
Time frame: at final therapy visit up to 12 weeks after enrollment
Other Treatments Received
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Aaron Lear, MD, CAQ principal investigator
Cleveland Clinic Akron General
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 tourniquet and Evidence based physical/occupational therapy in people with Lateral Epicondylitis, run by Cleveland Clinic Akron General 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 16 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: finished, as of the sponsor's last update on 5 May 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. 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?
Yes. Results are posted in the registry (first posted 5 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Patient Rated Tennis Elbow Evaluation (PRTEE) (time frame: 12 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 May 2026.