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

February 4, 2022 updated by: Tara Haugen, OTR/L, CBIS, United States Naval Medical Center, San Diego

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

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").

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Background: Lateral Epicondylalgia, or "tennis elbow", has been shown to affect up to 3% of the population and is a common musculoskeletal condition which also affects military service members. This study will compare clinical effectiveness of two treatment programs in individuals with lateral elbow pain.

Design: Prospective randomized controlled clinical trial

Methods: Participants, between the ages of 18-65, presenting to the NMCSD or NHCP Occupational or Physical Therapy Clinics with complaint of lateral elbow pain will be eligible for consideration to participate in this research. Patients that meet the inclusion criteria and elect to participate in the study will be randomized to either (1) a standardized, evidence based rehabilitation program or (2) an exercise volume matched group using personalized blood flow restriction (BFR) exercise.

Upon entry to the program subjects will complete measurements of height, body weight, physical activity level (Marx Activity Scale), annotation of their dominant upper extremity (UE), the patient-rated tennis elbow evaluation (PRTEE) questionnaire, Numerical Pain Rating Scale (NPRS), Patient-Reported Outcome Measurement Information System version 1.2- Global Health (PROMIS scale v1.2- Global Health), and grip strength using the JAMAR dynamometer. At the end of each treatment session subjects will complete the Numerical Pain Rating Scale (NPRS) and the OMNI-Resistance Exercise Scale (OMNI-RES) rating of perceived exertion (RPE) survey.

The standard rehabilitation group will perform active wrist extension, forearm supination, and gripping. These exercises may include isometric, concentric, or eccentric forms of strengthening contingent upon clinical decision making. Specifics of exercise performance (to include magnitude of resistance and volume of exercise) will be documented in the treatment record.

The Delphi Personalized Tourniquet System (PTS) will be utilized for the BFR exercises. The Delphi PTS measures an individual's personalized tourniquet pressure (PTP) using doppler technology similar to a blood pressure cuff. In the BFR exercise condition, subjects will perform a 30-15-15-15 repetition progression of 1-3 exercises as selected by the therapist.

Participants will be provided in-clinic treatment for a maximum of 12 sessions, one to three treatment sessions weekly, and may be discharged prior to that based upon shared decision making between the participant and therapist. The NPRS, grip strength, PROMIS scale v1.2- Global Health, and PRTEE will be completed at the last clinical appointment, as well as three and six-week, and three and six month follow up appointments. Twelve months following completion of occupational/physical therapy clinical care participants will be contacted and asked to complete a verbal NPRS, PROMIS scale v1.2- Global Health and the PRTEE outcome scale. Additionally, at 12 months following discharge from Physical or Occupational Therapy, the participants' EMR will be reviewed for follow-up visits related to the same condition (LET).

Data Analysis: A mixed effects longitudinal model will be utilized to assess for differences in the primary outcome measures (grip strength, NPRS, and PRTEE) between the time points of intake, end of occupational/physical therapy treatment, and three and six months post completion of treatment. Secondary analysis of change in OMNI-RES RPE and NPRS during the course of treatment will also be analyzed with a mixed effects longitudinal model. Healthcare provider(s) will be analyzed as a co-variate. Microsoft Excel and SPSS will function as the main data analysis instruments.

Clinical Implications: Results of this study are expected to guide clinician's selection of rehabilitation techniques to improve outcomes (increase strength, improve function, and decrease pain), improve mission readiness by earlier return to duty, reduce healthcare service costs, and also reduce lost duty/work time.

Study Type

Interventional

Enrollment (Anticipated)

104

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • California
      • San Diego, California, United States, 92134
        • Recruiting
        • Navy Medical Readiness & Training Command San Diego
        • Contact:
          • Tara Haugen, MSOT
          • Phone Number: 570-856-4375

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Taken at initial intake, and at the 3-week, 6-week, 3-month, 6-month and 12-month followup sessions

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

United States Naval Medical Center, San Diego

Investigators

  • Principal Investigator: Tara Haugen, MSOT, United States Naval Medical Center, San Diego

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2021

Primary Completion (Anticipated)

May 15, 2023

Study Completion (Anticipated)

June 30, 2023

Study Registration Dates

First Submitted

October 13, 2020

First Submitted That Met QC Criteria

October 23, 2020

First Posted (Actual)

October 29, 2020

Study Record Updates

Last Update Posted (Actual)

February 8, 2022

Last Update Submitted That Met QC Criteria

February 4, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NavalMCSD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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