CompletedNCT03978897Updated May 5, 2026Results posted

Trial of Blood Flow Restriction Plus Physical Therapy vs. Physical Therapy Alone for Lateral Epicondylitis

An interventional study of Blood flow restriction tourniquet and Evidence based physical/occupational therapy in Lateral Epicondylitis, sponsored by Cleveland Clinic Akron General. Completed at 1 site in United States. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-05.

Sponsored by Cleveland Clinic Akron General · Not applicable, Interventional, and Treatment

Phase: Not applicable
Study type: Interventional
Enrollment: 41
Allocation: Randomized
Ages: 18 Years to 70 Years
Sex: All

Study 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 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 studied

Lateral Epicondylitis

Browse trials for

Tennis Elbow 284

Keywords

lateral epicondylitis
tennis elbow
blood flow restriction
physical therapy

In context

Tennis Elbow

284 studies on the registry are indexed under Tennis Elbow; 60 are open to participants now.

This study's enrollment of 41 is below the median of 50 across 253 interventional studies indexed under Tennis Elbow.

Browse Tennis Elbow studies →

Lead sponsor

Cleveland Clinic Akron General is the lead sponsor of 6 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 70 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

Inclusion criteria

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.

Exclusion criteria

Exclusion Criteria:

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
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

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Single (Outcomes assessor)
Enrollment: 41 participants (actual)

Study arms

Experimental
Blood flow restriction with physical/occupational therapy
physical/occupational therapy including use of blood flow restriction tourniquet over 6 visits (within a twelve week period).
Device: Blood flow restriction tourniquet
Active comparator
Evidence based physical/occupational therapy
evidence based physical/occupational therapy program over 6 visits (within a twelve week period) without use of blood flow restriction tourniquet
Other: Evidence based physical/occupational therapy

Interventions

DeviceBlood flow restriction tourniquet
A blood flow restriction tourniquet, which impedes arterial flow to extremity at 50% of usual flow.
Also known as: Delfi personalized tourniquet system
OtherEvidence based physical/occupational therapy
Up to date physical/occupational therapy for lateral epicondylitis

What researchers measure

Primary outcomes

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)
Time frame: 12 months

Secondary outcomes

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.
Time frame: 12 months
Pain Free Grip Strength
Change in pain free grip strength (kg) on dynamometer from baseline to final PT visit (approximately 12 weeks)
Time frame: 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)
Time frame: 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
Time frame: 12 months

Results

Posted May 5, 2026

Participant flow

Participant flow — Overall Study
Milestone	Blood Flow Restriction With Physical/Occupational Therapy	Evidence Based Physical/Occupational Therapy
Started	19	22
Completed	17	18
Not completed	2	4

Outcome measures

PrimaryChange 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)

Time frame:: 12 months
Reported as:: Mean · score on a scale

Change in Patient Rated Tennis Elbow Evaluation (PRTEE)
score on a scale	Blood Flow Restriction With Physical/Occupational Therapy	Evidence Based Physical/Occupational Therapy
Change in Patient Rated Tennis Elbow Evaluation (PRTEE)	7.63 (-1.04 to 16.29)	17.27 (8.98 to 25.57)

SecondaryNumeric 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.

Time frame:: 12 months
Reported as:: Mean · 0-10 self assessment pain scale

Numeric Pain Rating Scale
0-10 self assessment pain scale	Blood Flow Restriction With Physical/Occupational Therapy	Evidence Based Physical/Occupational Therapy
Numeric Pain Rating Scale	1.12 (-0.25 to 2.49)	1.95 (.74 to 3.22)

SecondaryPain Free Grip Strength

Change in pain free grip strength (kg) on dynamometer from baseline to final PT visit (approximately 12 weeks)

Time frame:: at final therapy visit up to 12 weeks after enrollment
Reported as:: Mean · kg

Pain Free Grip Strength
kg	Blood Flow Restriction With Physical/Occupational Therapy	Evidence Based Physical/Occupational Therapy
Pain Free Grip Strength	10.13 (-6.62 to 26.87)	15.07 (0.3 to 29.85)

SecondaryMaximum Grip Strength

Change in maximum grip strength (kg) on dynamometer from baseline visit to final PT visit (approximately 12 weeks)

Time frame:: at final therapy visit up to 12 weeks after enrollment
Reported as:: Mean · kg

Maximum Grip Strength
kg	Blood Flow Restriction With Physical/Occupational Therapy	Evidence Based Physical/Occupational Therapy
Maximum Grip Strength	11.21 (-7.29 to 29.7)	26.05 (9.79 to 42.32)

SecondaryOther 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

Time frame:: 12 months
Reported as:: Number · Number of patients receiving other treat

Other Treatments Received
Number of patients receiving other treat	Blood Flow Restriction With Physical/Occupational Therapy	Evidence Based Physical/Occupational Therapy
Other Treatments Received	2	4

Adverse events

Collected over 0-12 weeks of physical therapy. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Blood Flow Restriction With Physical/Occupational Therapy	0/19 (0%)	0/19 (0%)	0/19 (0%)
Evidence Based Physical/Occupational Therapy	0/22 (0%)	0/22 (0%)	0/22 (0%)

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)	Blood Flow Restriction With Physical/Occupational Therapy	Evidence Based Physical/Occupational Therapy	Total
<=18 years	0	0	0
Between 18 and 65 years	18	19	37
>=65 years	1	3	4

Age, Continuous
Age, Continuous(years)	Blood Flow Restriction With Physical/Occupational Therapy	Evidence Based Physical/Occupational Therapy	Total
Mean	55 (44 to 56)	51.5 (42 to 60.5)	52 (42 to 58)

Sex: Female, Male
Sex: Female, Male(Participants)	Blood Flow Restriction With Physical/Occupational Therapy	Evidence Based Physical/Occupational Therapy	Total
Female	12	10	22
Male	7	12	19

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Blood Flow Restriction With Physical/Occupational Therapy	Evidence Based Physical/Occupational Therapy	Total
American Indian or Alaska Native	0	0	0
Asian	0	0	0
Native Hawaiian or Other Pacific Islander	0	0	0
Black or African American	0	0	0
White	18	19	37
More than one race	0	0	0
Unknown or Not Reported	1	3	4

Region of Enrollment
Region of Enrollment(participants)	Blood Flow Restriction With Physical/Occupational Therapy	Evidence Based Physical/Occupational Therapy	Total
United States	19	22	41

Study locations

1 site

Cleveland Clinic Akron General
Akron, Ohio 44307, United States

References and documents

Study documents

Protocol and statistical analysis plan · Mar 20, 2026

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on May 5, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT03978897
Lead sponsor: Cleveland Clinic Akron General
Responsible party: Aaron Lear (Director of Primary Care Sports Medicine, Cleveland Clinic Akron General) — Principal investigator
First posted: Jun 7, 2019
Start date: Jul 1, 2019
Primary completion: Dec 31, 2024
Completion: Dec 31, 2024
Results posted: May 5, 2026
Last update: May 5, 2026

Study contacts

Aaron Lear, MD, CAQ

principal investigator · Cleveland Clinic Akron General

Oversight

FDA-regulated drug: No
FDA-regulated device: Yes

View the source record on ClinicalTrials.gov ↗

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