Recruiting

Blood Flow Restriction

Sponsor:

United States Naval Medical Center, San Diego

Code:

NCT04607356

Conditions

Tennis Elbow

Lateral Epicondylitis

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Blood Flow Restriction (BFR)

Evidence-informed care

Study Details

Brief summary:

The purpose of this study is to compare the clinical effectiveness and outcomes between current evidence based clinical care and use of personalized blood flow restriction training in the treatment of lateral epicondylalgia ("tennis elbow").

Conditions

Tennis Elbow

Lateral Epicondylitis

Study ID

NCT04607356

Start date

Mar 1, 2021

Status verified date

Feb, 2022

Completion date

Jun 30, 2023

Anticipated

Primary completion date

May 15, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Diagnosis of lateral elbow pain (e.g. "tennis elbow" or wrist extensor tendinopathy)
2. Between the ages of 18-65
3. Elbow pain for 4 weeks or more

Exclusion Criteria:

1. Ligamentous elbow sprain, osteoarthritis of elbow and cervical radiculopathy in the affected limb will be excluded from the study.
2. Any history of ligamentous, bony or other soft tissue reconstruction surgery at the affected elbow.
3. Vascular disorders to include: history of DVT, history of endothelial dysfunction, peripheral vascular disease
4. Current fracture in affected arm
5. History of crush injury to affected arm
6. Any surgery on affected arm in last 1 year
7. Surgery within last year on contralateral upper extremity
8. History of lymphectomy (such as axillary exploration with breast surgery, lymph node biopsy in the affected axilla/arm)
9. Pregnancy
10. Active infection
11. Current cancer diagnosis/treatment
12. Sickle cell anemia or trait
13. Kidney dialysis
14. History of syncope/passing out with pressure to body (such as massage, or blood pressure cuff).
15. Inability to consent
16. Thromboembolism
17. Varicose veins
18. Cardiovascular disorders
19. Taking anti-coagulant medications
20. Bleeding disorder
21. Instructed by a physician or medical practitioner that they are not cleared to exercise

Study Design

Enrollment

104 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Evidence-informed care

Standardized, evidence based rehabilitation program for lateral epicondylalgia to include: discussion of ergonomics, home exercise program performance, use of any prescribed splint or brace, forearm and shoulder stretches, soft tissue mobilization, and performance of standard resistance exercises.

experimental: Evidence-informed care + Blood Flow Restriction (BFR)

Standardized, evidence based rehabilitation program for lateral epicondylalgia to include: discussion of ergonomics, home exercise program performance, use of any prescribed splint or brace, forearm and shoulder stretches, soft tissue mobilization, and performance of standard resistance exercises with the addition of BFR while performing resistive exercises.

Interventions

Blood Flow Restriction (BFR)

The Delphi Personalized Tourniquet System (PTS) will be utilized for the BFR exercises. The external constriction device will be applied to the proximal aspect of an individual's limb to restrict the flow of blood into and out of the extremity at 50% of usual flow. Subjects will perform a 30-15-15-15 repetition progression of 1-3 exercises as selected by the therapist. The Delphi PTS cuff is inflated at the start of the exercise and remains inflated throughout the exercise. Once the participant has completed an exercise, the cuff is deflated for 1 minute and the same cycle is performed for each subsequent exercise.

Evidence-informed care

Evidence-based resistive exercises, stretches, soft tissue mobilization and patient education for lateral epicondylalgia.

Primary outcome measure

  • Numerical Pain Rating Scale [ Time Frame: Taken at initial intake, after completion of each treatment session (up to 12 total sessions following initial evaluation), and at the 3-week, 6-week, 3-month, 6-month and 12-month followup sessions ]
  • Patient-rated tennis elbow evaluation (PRTEE) [ Time Frame: Taken at initial intake, and at the 3-week, 6-week, 3-month, 6-month and 12-month followup sessions ]
  • Grip Strength [ Time Frame: Taken at initial intake, and at the 3-week, 6-week, 3-month, and 6-month follow-up sessions ]

Central Contacts and Locations

Central contacts

Locations

Navy Medical Readiness & Training Command San Diego

Recruiting

San Diego, California, United States, 92134

Contacts

Tara Haugen, MSOT

570-856-4375

More Information

Sponsor

United States Naval Medical Center, San Diego

Last update posted

Feb 8, 2022

Last verified

Feb, 2022

Keywords

  • Physical Therapy
  • Blood Flow Restriction
  • Tennis Elbow
  • Lateral Epicondylalgia

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by United States Naval Medical Center, San Diego on 2022-02-08.