Tissue Flossing in Tennis Elbow Patients (FLOSS)

February 6, 2019 updated by: DAVID CRUZ DÍAZ, University of Jaén

The Effect of Tissue Flossing in Patients With Tennis Elbow

The aim of the present intervention is to determine the effectiveness of the application of tissue flossing in patients with tennis elbow

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The application of tissue flossing has been deemed to provide beneficial results in patients with ankle range of motion limitation. Although, tissue flossing is widely extended among athletes due to its effectiveness in pain, function and range of motion, the evidence is limited.

The aim of the present protocol is to determine the effectiveness of tissue flossing in patients with tennis elbow.

Study Type

Interventional

Enrollment (Anticipated)

50

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 Locations

  • Spain
      • Jaen, Spain, 23071
        • University of Jaén

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 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Elbow pain for at least 6 weeks and satisfy the widely accepted diagnostic criteria of lateral epicondylalgia.
  • Diagnostic criteria are pain over the lateral humeral epicondyle that is provoked by gripping activities.
  • Reduced grip strength and increased sensitivity to manual palpation over the lateral epicondyle.
  • Pain with stretching or contraction of the wrist extensor muscles.

Exclusion Criteria:

  • Upper limb fractures, surgery or concomitant disease.
  • Red flags presence.
  • Mental disorders.

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
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Tissue flossing
Conventional physiotherapy consisted in electrotherapy and stretching in addition to tissue flossing.
Other: Tissue flossing
Electrotherapy (transcutaneous electrical nerve stimulation) and Ultrasound in addition to tissue flossing.
PLACEBO_COMPARATOR: Placebo comparator
Conventional physiotherapy consisted in electrotherapy and stretching in addition with tissue flossing without tension.
Other: Placebo comparator
Conventional physiotherapy in addition to flossing without tension

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient-related Tennis Elbow Questionnaire change
Time Frame: At baseline, after 1 week and after 4 week.
Self reported questionnaire ranged from 0 to 150 with greater scores associated with severe disability.
At baseline, after 1 week and after 4 week.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Numeric rating scale change
Time Frame: At baseline, after 1 week and after 4 week.
10 point rating scale of pain where 0 is associated with no pain and 10 with greatest pain.
At baseline, after 1 week and after 4 week.
Pressure Pain Threshold change
Time Frame: At baseline, after 1 week and after 4 week.
Determine the pain free pression with a validated instrument
At baseline, after 1 week and after 4 week.

Collaborators and Investigators

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

Sponsor

University of Jaén

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 (ANTICIPATED)

February 20, 2019

Primary Completion (ANTICIPATED)

March 28, 2019

Study Completion (ANTICIPATED)

April 10, 2019

Study Registration Dates

First Submitted

February 4, 2019

First Submitted That Met QC Criteria

February 6, 2019

First Posted (ACTUAL)

February 7, 2019

Study Record Updates

Last Update Posted (ACTUAL)

February 7, 2019

Last Update Submitted That Met QC Criteria

February 6, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Ujaenflossing

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

This intervention could be beneficial to support or refuse the use of tissue flossing.

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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