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Blood Flow Restriction Exercise in the Treatment of Lateral Epicondylalgia Traditional Treatment

NCT04607356 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 104

Last updated 2022-02-08

No results posted yet for this study

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

Interventions

DEVICE

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.

OTHER

Evidence-informed care

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

Sponsors & Collaborators

  • United States Naval Medical Center, San Diego

    lead FED

Principal Investigators

  • Tara Haugen, MSOT · United States Naval Medical Center, San Diego

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-01
Primary Completion
2023-05-15
Completion
2023-06-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04607356 on ClinicalTrials.gov