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Blood Flow Restriction Exercise in the Treatment of Lateral Epicondylalgia Traditional Treatment (BFR)

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ClinicalTrials.gov Identifier: NCT04607356
Recruitment Status : Recruiting
First Posted : October 29, 2020
Last Update Posted : February 8, 2022
Sponsor:
Information provided by (Responsible Party):
Tara Haugen, OTR/L, CBIS, United States Naval Medical Center, San Diego

Study Description
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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").

Condition or disease Intervention/treatment Phase
Tennis Elbow Lateral Epicondylitis Device: Blood Flow Restriction (BFR) Other: Evidence-informed care Not Applicable

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Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 104 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized control trial
Masking: Single (Outcomes Assessor)
Masking Description: Treating therapists and patient will be aware of treatment. Grip strength objective measure will be performed by a clinician blinded to the participant's treatment group. All other outcome measures are patient-reported on outcome forms.
Primary Purpose: Treatment
Official Title: Blood Flow Restriction Exercise in the Treatment of Lateral Epicondylalgia vs Traditional Treatment
Actual Study Start Date : March 1, 2021
Estimated Primary Completion Date : May 15, 2023
Estimated Study Completion Date : June 30, 2023

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Arms and Interventions
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Arm Intervention/treatment
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.
 Other: Evidence-informed care
Evidence-based resistive exercises, stretches, soft tissue mobilization and patient education for lateral epicondylalgia.
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.
 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.


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]
    Change in score on 0-10 pain rating scale with 0 being no pain, and 10 being worst pain

  2. 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 ]
    Change in score of the patient reported outcome measure (form): rating pain as well as difficulty on a scale of 0-10 with certain movements and functional activities. Lower numbers suggest less pain, higher scores suggest more pain. Total score 0-100.

  3. Grip Strength [ Time Frame: Taken at initial intake, and at the 3-week, 6-week, 3-month, and 6-month follow-up sessions ]
    Assessing change in grip strength using the JAMAR dynamometer- taken with elbow straight, average of 3 measurements recorded.


Secondary Outcome Measures :
  1. Patient-Reported Outcome Measurement Information System version 1.2- Global Health [ Time Frame: Taken at initial intake, and at the 3-week, 6-week, 3-month, 6-month and 12-month followup sessions ]
    Looking at mental health factors


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04607356


Contacts
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Contact: Tara Haugen, MSOT 570-856-4375 tara.a.haugen.mil@mail.mil
Contact: Michael Rosenthal, DPT 619-865-8611 mrosenthal@sdsu.edu

Locations
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United States, California
Navy Medical Readiness & Training Command San Diego Recruiting
San Diego, California, United States, 92134
Contact: Tara Haugen, MSOT    570-856-4375      
Sponsors and Collaborators
United States Naval Medical Center, San Diego
Investigators
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Principal Investigator: Tara Haugen, MSOT United States Naval Medical Center, San Diego
More Information
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Publications of Results:

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Responsible Party: Tara Haugen, OTR/L, CBIS, LT, Physical Therapist, United States Naval Medical Center, San Diego
ClinicalTrials.gov Identifier: NCT04607356    
Other Study ID Numbers: NavalMCSD
First Posted: October 29, 2020    Key Record Dates
Last Update Posted: February 8, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Tara Haugen, OTR/L, CBIS, United States Naval Medical Center, San Diego:
Physical Therapy
Blood Flow Restriction
Tennis Elbow
Lateral Epicondylalgia
Additional relevant MeSH terms:
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Tennis Elbow
Elbow Tendinopathy
Tendinopathy
Muscular Diseases
 Musculoskeletal Diseases
Arm Injuries
Wounds and Injuries
Tendon Injuries