Tissue Flossing in Tennis Elbow Patients
FLOSS
The Effect of Tissue Flossing in Patients With Tennis Elbow
1 other identifier
interventional
50
1 country
1
Brief Summary
The aim of the present intervention is to determine the effectiveness of the application of tissue flossing in patients with tennis elbow
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2019
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 4, 2019
CompletedFirst Posted
Study publicly available on registry
February 7, 2019
CompletedStudy Start
First participant enrolled
February 20, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 28, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
April 10, 2019
CompletedFebruary 7, 2019
February 1, 2019
1 month
February 4, 2019
February 6, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Patient-related Tennis Elbow Questionnaire change
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 Outcomes (2)
Numeric rating scale change
At baseline, after 1 week and after 4 week.
Pressure Pain Threshold change
At baseline, after 1 week and after 4 week.
Study Arms (2)
Tissue flossing
EXPERIMENTALConventional physiotherapy consisted in electrotherapy and stretching in addition to tissue flossing.
Placebo comparator
PLACEBO COMPARATORConventional physiotherapy consisted in electrotherapy and stretching in addition with tissue flossing without tension.
Interventions
Electrotherapy (transcutaneous electrical nerve stimulation) and Ultrasound in addition to tissue flossing.
Conventional physiotherapy in addition to flossing without tension
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Upper limb fractures, surgery or concomitant disease.
- Red flags presence.
- Mental disorders.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Jaen
Jaén, 23071, Spain
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
David Cruz-Diaz, PhD
University of Jaen
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- 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.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Vice Dean
Study Record Dates
First Submitted
February 4, 2019
First Posted
February 7, 2019
Study Start
February 20, 2019
Primary Completion
March 28, 2019
Study Completion
April 10, 2019
Last Updated
February 7, 2019
Record last verified: 2019-02