Back to resultsTissue Flossing in Tennis Elbow Patients (FLOSS)
Primary Purpose
Tennis Elbow
Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Tissue flossing
Placebo comparator
Sponsored by
About this trial
This is an interventional treatment trial for Tennis Elbow focused on measuring physiotherapy
Eligibility Criteria
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.
Sites / Locations
- University of Jaen
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Tissue flossing
Placebo comparator
Arm Description
Conventional physiotherapy consisted in electrotherapy and stretching in addition to tissue flossing.
Conventional physiotherapy consisted in electrotherapy and stretching in addition with tissue flossing without tension.
Outcomes
Primary Outcome Measures
Patient-related Tennis Elbow Questionnaire change
Self reported questionnaire ranged from 0 to 150 with greater scores associated with severe disability.
Secondary Outcome Measures
Numeric rating scale change
10 point rating scale of pain where 0 is associated with no pain and 10 with greatest pain.
Pressure Pain Threshold change
Determine the pain free pression with a validated instrument
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03834077
Brief Title
Tissue Flossing in Tennis Elbow Patients
Acronym
FLOSS
Official Title
The Effect of Tissue Flossing in Patients With Tennis Elbow
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Unknown status
Study Start Date
February 20, 2019 (Anticipated)
Primary Completion Date
March 28, 2019 (Anticipated)
Study Completion Date
April 10, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Jaén
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The aim of the present intervention is to determine the effectiveness of the application of tissue flossing in patients with tennis elbow
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tennis Elbow
Keywords
physiotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled trial
Masking
Care ProviderInvestigatorOutcomes Assessor
Masking Description
Patients will be allocated to intervention (flossing) or control group (conventional physiotherapy) using a randomized list of allocated numbers generated by a computer program. Opaque envelope will contain the patients allocation while outcome assessors, care provider and principal investigator will be blinded to the allocation process.
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Tissue flossing
Arm Type
Experimental
Arm Description
Conventional physiotherapy consisted in electrotherapy and stretching in addition to tissue flossing.
Arm Title
Placebo comparator
Arm Type
Placebo Comparator
Arm Description
Conventional physiotherapy consisted in electrotherapy and stretching in addition with tissue flossing without tension.
Intervention Type
Other
Intervention Name(s)
Tissue flossing
Intervention Description
Electrotherapy (transcutaneous electrical nerve stimulation) and Ultrasound in addition to tissue flossing.
Intervention Type
Other
Intervention Name(s)
Placebo comparator
Intervention Description
Conventional physiotherapy in addition to flossing without tension
Primary Outcome Measure Information:
Title
Patient-related Tennis Elbow Questionnaire change
Description
Self reported questionnaire ranged from 0 to 150 with greater scores associated with severe disability.
Time Frame
At baseline, after 1 week and after 4 week.
Secondary Outcome Measure Information:
Title
Numeric rating scale change
Description
10 point rating scale of pain where 0 is associated with no pain and 10 with greatest pain.
Time Frame
At baseline, after 1 week and after 4 week.
Title
Pressure Pain Threshold change
Description
Determine the pain free pression with a validated instrument
Time Frame
At baseline, after 1 week and after 4 week.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
David Cruz-Diaz, PhD
Phone
953213408
Email
dcruz@ujaen.es
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Cruz-Diaz, PhD
Organizational Affiliation
University of Jaen
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Jaen
City
Jaen
ZIP/Postal Code
23071
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
This intervention could be beneficial to support or refuse the use of tissue flossing.
Learn more about this trial
Tissue Flossing in Tennis Elbow Patients
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