- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03834077
Tissue Flossing in Tennis Elbow Patients (FLOSS)
The Effect of Tissue Flossing in Patients With Tennis Elbow
Study Overview
Status
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
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: David Cruz-Diaz, PhD
- Phone Number: 953213408
- Email: dcruz@ujaen.es
Study Locations
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Jaen, Spain, 23071
- University of Jaén
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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.
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Electrotherapy (transcutaneous electrical nerve stimulation) and Ultrasound in addition to tissue flossing.
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PLACEBO_COMPARATOR: Placebo comparator
Conventional physiotherapy consisted in electrotherapy and stretching in addition with tissue flossing without tension.
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Conventional physiotherapy in addition to flossing without tension
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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.
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Self reported questionnaire ranged from 0 to 150 with greater scores associated with severe disability.
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At baseline, after 1 week and after 4 week.
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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.
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At baseline, after 1 week and after 4 week.
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Pressure Pain Threshold change
Time Frame: At baseline, after 1 week and after 4 week.
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Determine the pain free pression with a validated instrument
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At baseline, after 1 week and after 4 week.
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ANTICIPATED)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Tennis Elbow
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Indiana Hand to Shoulder CenterCTM BiomedicalEnrolling by invitationTennis Elbow | Lateral Elbow Tendinopathy | Lateral Epicondylitis \(Tennis Elbow\)United States
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HydroCision, Inc.CompletedElbow, TennisUnited States
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Travanti Pharma Inc.Cetero Research, San AntonioUnknownLateral Epicondylitis (Tennis Elbow)United States
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Haseki Training and Research HospitalCompletedLateral Epicondylitis (Tennis Elbow)Turkey
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Travanti Pharma Inc.ResearchPointCompletedLateral Epicondylitis | (Tennis Elbow)United States
Clinical Trials on Tissue flossing
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Riphah International UniversityCompleted
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Paulista UniversityNot yet recruitingHypertrophy | Muscle StrengthBrazil
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Józef Piłsudski University of Physical EducationCompletedHealth Behavior | Muscle Strain, Lower LegPoland
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Riphah International UniversityCompletedKnee OsteoarthritisPakistan
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Science and Research Centre KoperUniversity of LjubljanaCompletedIschemia | Placebo - ControlSlovenia
-
Mashhad University of Medical SciencesCompletedDental Devices, Home CareIran, Islamic Republic of
-
Uttaranchal Dental & Medical Research InstituteCompletedOral Hygiene | Dental Devices, Home CareIndia