Effects Compressive Tissue Flossing on Lateral Elbow Tendinopathy in US Service Members

April 15, 2024 updated by: John Edgar Elam, Brooke Army Medical Center

The Effects of a Compressive Tissue Flossing Program on the Symptoms of Lateral Elbow Tendinopathy in United States Service Members

The purpose of this research study will be to assess the effects of a compressive tissue flossing (CTF) program on the symptoms of lateral elbow tendinopathy in United States service members. Dependent variables will be the Defense and Veteran's Pain Rating Scale (DVPRS), decrease their Patient-Rated Tennis Elbow Evaluation (PRTEE) score, increase their maximal grip strength in the affected upper extremity (UE). Measurements will be taken at baseline, immediately after the first CTF intervention, and at the 1-week follow-up, for a total of 3 measurements.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The purpose of this research study will be to assess the effects of a compressive tissue flossing (CTF) program on the symptoms of lateral elbow tendinopathy in United States service members. I hypothesize that tissue flossing with a band for a 2-minute session daily will decrease patient's report of pain on the Defense and Veteran's Pain Rating Scale (DVPRS), decrease their Patient-Rated Tennis Elbow Evaluation (PRTEE) score, increase their maximal grip strength in the affected upper extremity (UE). Measurements will be taken at baseline, immediately after the first CTF intervention, and at the 1-week follow-up, for a total of 3 measurements. If this method is shown to acutely decrease the symptoms of LET, it would give occupational therapists a potential home exercise program that is easy to initiate and only takes 2 minutes per day for patients to perform. This could prove to be an effective and low-cost method for service members to treat elbow pain symptoms. This technique could be used in austere environments where traditional musculoskeletal rehabilitation may not be available.

Specific Aim 1: Assess the acute effects of compressive tissue flossing on the symptoms of lateral elbow tendinopathy in United States service members.

I will accomplish this by recording the patient's report of pain on the Defense and Veteran's Pain Rating Scale, their Patient-Rated Tennis Elbow Evaluation outcome measure score, and their maximal grip strength in the affected UE before CTF, immediately after CTF, and at the 1-week follow-up after completing tissue flossing daily for 2 minutes. I will compare the outcomes from each measurement to evaluate the effects of CTF on lateral elbow pain symptoms.

Study Type

Interventional

Enrollment (Estimated)

35

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
    • Texas
      • Fort Sam Houston, Texas, United States, 78234
        • Recruiting
        • Brooke Army Medical Center
        • Contact:
        • Contact:
        • Principal Investigator:
          • John E Elam, DSc Fellow
        • Sub-Investigator:
          • Carly R Cooper, PhD
        • Sub-Investigator:
          • Katelyn A Culley, DSc Fellow
        • Sub-Investigator:
          • Tara A Haugen, DSc Fellow

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • United States military service members stationed at JBSA between the ages of 18 to 65
  • Report of lateral elbow pain
  • Can perform either a modified push-up or push-up for 1 minute.

Exclusion Criteria:

  • Under 18 years old or over 65 years old
  • Recent surgical treatment of the involved upper extremity
  • Current fracture of the involved upper extremity
  • Open wounds at the treatment area
  • History of skin diseases
  • Tumors at the treatment area
  • History of a peripheral vascular condition
  • History of chronic inflammatory processes
  • Latex allergy
  • History of varicose veins
  • History of vein inflammation
  • History of thrombosis
  • Diagnosed with diabetes
  • Diagnosed with cardiac insufficiency Stage C or D
  • Diagnosed with lymphedema
  • Currently taking blood thinners
  • Currently receiving high-dose corticosteroids
  • Currently receiving other therapy for the elbow pain
  • Presently diagnosed with cervical radiculopathy

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient's report of pain on the Defense and Veteran's Pain Rating Scale
Time Frame: 1 week
This pain scale assesses the participant's perceived pain on a scale from 0-10. ) being no pain and 10 being as bad as the pain could possibly be. A participant rating their pain lower post-intervention would indicate a positive outcome.
1 week
Patient-Rated Tennis Elbow Evaluation
Time Frame: 1 week
Minimum value is 0 and maximum value is 100. 0 indicates that lateral elbow pain has no effect on the participant, whereas an increased score indicates the participant's lateral elbow pain has an increased effect on ability to perform activities and a worse outcome.
1 week
Maximal grip strength in the affected upper extremity
Time Frame: 1 week
Maximal grip strength will be recorded by the participant squeezing a calibrated dynamometer, which is a measurement tool used to calculate grip strength in pounds per square inch. The amount of grip strength generated in pounds per square inch in the affected upper extremity will be compared to maximal grip strength after the intervention is implemented day 1 and after 1 week.
1 week

Collaborators and Investigators

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

Sponsor

Brooke Army Medical Center

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)

February 13, 2024

Primary Completion (Estimated)

May 1, 2024

Study Completion (Estimated)

June 1, 2024

Study Registration Dates

First Submitted

February 13, 2024

First Submitted That Met QC Criteria

April 15, 2024

First Posted (Actual)

April 17, 2024

Study Record Updates

Last Update Posted (Actual)

April 17, 2024

Last Update Submitted That Met QC Criteria

April 15, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C.2024.019

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

No

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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