Trial Outcomes & Findings for Trial of Blood Flow Restriction Plus Physical Therapy vs. Physical Therapy Alone for Lateral Epicondylitis (NCT NCT03978897)

Last Updated: 2026-05-05

Results Overview

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)

Recruitment status

COMPLETED

Study phase

Target enrollment

41 participants

Primary outcome timeframe

12 months

Results posted on

2026-05-05

Participant Flow

Participant milestones

Participant milestones
Measure	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). Blood flow restriction tourniquet: A blood flow restriction tourniquet, which impedes arterial flow to extremity at 50% of usual flow.	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 Evidence based physical/occupational therapy: Up to date physical/occupational therapy for lateral epicondylitis
Overall Study STARTED	19	22
Overall Study COMPLETED	17	18
Overall Study NOT COMPLETED	2	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Blood Flow Restriction With Physical/Occupational Therapy n=19 Participants physical/occupational therapy including use of blood flow restriction tourniquet over 6 visits (within a twelve week period). Blood flow restriction tourniquet: A blood flow restriction tourniquet, which impedes arterial flow to extremity at 50% of usual flow.	Evidence Based Physical/Occupational Therapy n=22 Participants evidence based physical/occupational therapy program over 6 visits (within a twelve week period) without use of blood flow restriction tourniquet Evidence based physical/occupational therapy: Up to date physical/occupational therapy for lateral epicondylitis	Total n=41 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=54 Participants	0 Participants n=60 Participants	0 Participants n=114 Participants
Age, Categorical Between 18 and 65 years	18 Participants n=54 Participants	19 Participants n=60 Participants	37 Participants n=114 Participants
Age, Categorical >=65 years	1 Participants n=54 Participants	3 Participants n=60 Participants	4 Participants n=114 Participants
Age, Continuous	55 years n=54 Participants	51.5 years n=60 Participants	52 years n=114 Participants
Sex: Female, Male Female	12 Participants n=54 Participants	10 Participants n=60 Participants	22 Participants n=114 Participants
Sex: Female, Male Male	7 Participants n=54 Participants	12 Participants n=60 Participants	19 Participants n=114 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=54 Participants	0 Participants n=60 Participants	0 Participants n=114 Participants
Race (NIH/OMB) Asian	0 Participants n=54 Participants	0 Participants n=60 Participants	0 Participants n=114 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=54 Participants	0 Participants n=60 Participants	0 Participants n=114 Participants
Race (NIH/OMB) Black or African American	0 Participants n=54 Participants	0 Participants n=60 Participants	0 Participants n=114 Participants
Race (NIH/OMB) White	18 Participants n=54 Participants	19 Participants n=60 Participants	37 Participants n=114 Participants
Race (NIH/OMB) More than one race	0 Participants n=54 Participants	0 Participants n=60 Participants	0 Participants n=114 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=54 Participants	3 Participants n=60 Participants	4 Participants n=114 Participants
Region of Enrollment United States	19 participants n=54 Participants	22 participants n=60 Participants	41 participants n=114 Participants

PRIMARY outcome

Timeframe: 12 months

Outcome measures

Outcome measures
Measure	Blood Flow Restriction With Physical/Occupational Therapy n=17 Participants physical/occupational therapy including use of blood flow restriction tourniquet over 6 visits (within a twelve week period). Blood flow restriction tourniquet: A blood flow restriction tourniquet, which impedes arterial flow to extremity at 50% of usual flow.	Evidence Based Physical/Occupational Therapy n=18 Participants evidence based physical/occupational therapy program over 6 visits (within a twelve week period) without use of blood flow restriction tourniquet Evidence based physical/occupational therapy: Up to date physical/occupational therapy for lateral epicondylitis
Change in Patient Rated Tennis Elbow Evaluation (PRTEE)	7.63 score on a scale Interval -1.04 to 16.29	17.27 score on a scale Interval 8.98 to 25.57

SECONDARY outcome

Timeframe: 12 months

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.

Outcome measures

Outcome measures
Measure	Blood Flow Restriction With Physical/Occupational Therapy n=17 Participants physical/occupational therapy including use of blood flow restriction tourniquet over 6 visits (within a twelve week period). Blood flow restriction tourniquet: A blood flow restriction tourniquet, which impedes arterial flow to extremity at 50% of usual flow.	Evidence Based Physical/Occupational Therapy n=18 Participants evidence based physical/occupational therapy program over 6 visits (within a twelve week period) without use of blood flow restriction tourniquet Evidence based physical/occupational therapy: Up to date physical/occupational therapy for lateral epicondylitis
Numeric Pain Rating Scale	1.12 0-10 self assessment pain scale Interval -0.25 to 2.49	1.95 0-10 self assessment pain scale Interval 0.74 to 3.22

SECONDARY outcome

Timeframe: at final therapy visit up to 12 weeks after enrollment

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

Outcome measures

Outcome measures
Measure	Blood Flow Restriction With Physical/Occupational Therapy n=17 Participants physical/occupational therapy including use of blood flow restriction tourniquet over 6 visits (within a twelve week period). Blood flow restriction tourniquet: A blood flow restriction tourniquet, which impedes arterial flow to extremity at 50% of usual flow.	Evidence Based Physical/Occupational Therapy n=19 Participants evidence based physical/occupational therapy program over 6 visits (within a twelve week period) without use of blood flow restriction tourniquet Evidence based physical/occupational therapy: Up to date physical/occupational therapy for lateral epicondylitis
Pain Free Grip Strength	10.13 kg Interval -6.62 to 26.87	15.07 kg Interval 0.3 to 29.85

SECONDARY outcome

Timeframe: at final therapy visit up to 12 weeks after enrollment

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

Outcome measures

Outcome measures
Measure	Blood Flow Restriction With Physical/Occupational Therapy n=19 Participants physical/occupational therapy including use of blood flow restriction tourniquet over 6 visits (within a twelve week period). Blood flow restriction tourniquet: A blood flow restriction tourniquet, which impedes arterial flow to extremity at 50% of usual flow.	Evidence Based Physical/Occupational Therapy n=22 Participants evidence based physical/occupational therapy program over 6 visits (within a twelve week period) without use of blood flow restriction tourniquet Evidence based physical/occupational therapy: Up to date physical/occupational therapy for lateral epicondylitis
Maximum Grip Strength	11.21 kg Interval -7.29 to 29.7	26.05 kg Interval 9.79 to 42.32

SECONDARY outcome

Timeframe: 12 months

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

Outcome measures

Outcome measures
Measure	Blood Flow Restriction With Physical/Occupational Therapy n=19 Participants physical/occupational therapy including use of blood flow restriction tourniquet over 6 visits (within a twelve week period). Blood flow restriction tourniquet: A blood flow restriction tourniquet, which impedes arterial flow to extremity at 50% of usual flow.	Evidence Based Physical/Occupational Therapy n=22 Participants evidence based physical/occupational therapy program over 6 visits (within a twelve week period) without use of blood flow restriction tourniquet Evidence based physical/occupational therapy: Up to date physical/occupational therapy for lateral epicondylitis
Other Treatments Received	2 Number of patients receiving other treat	4 Number of patients receiving other treat

Adverse Events

Blood Flow Restriction With Physical/Occupational Therapy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Evidence Based Physical/Occupational Therapy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Aaron Lear

Cleveland Clinic

Phone: 330.344.6047

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place