Tennis ElbowFLOSSNCT03834077
Tissue Flossing in Tennis Elbow Patients
A study testing Tissue flossing in people with Tennis Elbow, run by University of Jaén at 1 site in Spain.
Trial summary
The aim of the present intervention is to determine the effectiveness of the application of tissue flossing in patients with tennis elbow Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Tennis Elbow
- What is being tested?
- Tissue flossing
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteSpain
- Study dates
- 20 Feb 2019to 10 Apr 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- Upper limb fractures, surgery or concomitant disease.
- Red flags presence.
- Mental disorders.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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.
- Conditions
- Tennis Elbow
- Being tested
- Tissue flossing, Placebo comparator
- Keywords
- physiotherapy
- Medical subject headings
- Tennis Elbow
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tissue flossingOther
Electrotherapy (transcutaneous electrical nerve stimulation) and Ultrasound in addition to tissue flossing.
Placebo comparatorOther
Conventional physiotherapy in addition to flossing without tension
| Study group | Role | What they receive |
|---|---|---|
| Tissue flossing | Experimental | Conventional physiotherapy consisted in electrotherapy and stretching in addition to tissue flossing. Receives: Other: Tissue flossing |
| Placebo comparator | Placebo comparator | Conventional physiotherapy consisted in electrotherapy and stretching in addition with tissue flossing without tension. Receives: Other: Placebo comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient-related Tennis Elbow Questionnaire change
Self reported questionnaire ranged from 0 to 150 with greater scores associated with severe disability.
Measured: At baseline, after 1 week and after 4 week.
Secondary outcomes (2)
Numeric rating scale change
10 point rating scale of pain where 0 is associated with no pain and 10 with greatest pain.
Measured: At baseline, after 1 week and after 4 week.
Pressure Pain Threshold change
Determine the pain free pression with a validated instrument
Measured: At baseline, after 1 week and after 4 week.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2019
- Study start20 Feb 2019 (estimated)
- Primary completion28 Mar 2019 (estimated)
- Study completion10 Apr 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tennis ElbowStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Jaén
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, DAVID CRUZ DÍAZ, University of Jaén
- Investigators
- David Cruz-Diaz, PhD, Principal investigator, University of Jaen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03834077
- Sponsor's protocol ID
- Ujaenflossing
- Acronym
- FLOSS
- Status last verified
- Feb 2019
- First submitted
- 4 Feb 2019
- Last updated
- 7 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: This intervention could be beneficial to support or refuse the use of tissue flossing.
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Tissue Flossing in Patients With Tennis Elbow
- ClinicalTrials.gov ID
- NCT03834077
- Acronym / sponsor ID
- FLOSS / Ujaenflossing
- Conditions
- Tennis Elbow
- Keywords
- physiotherapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of JaénUniversity, hospital or other
- Study start
- 20 Feb 2019 (estimated)
- Primary completion
- 28 Mar 2019 (estimated)
- Study completion
- 10 Apr 2019 (estimated)
- First posted
- 7 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Tissue flossing | Experimental | Other: Tissue flossingConventional physiotherapy consisted in electrotherapy and stretching in addition to tissue flossing. |
| Placebo comparator | Placebo comparator | Other: Placebo comparatorConventional physiotherapy consisted in electrotherapy and stretching in addition with tissue flossing without tension. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- Upper limb fractures, surgery or concomitant disease.
- Red flags presence.
- Mental disorders.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tissue flossingElectrotherapy (transcutaneous electrical nerve stimulation) and Ultrasound in addition to tissue flossing. | Other | Tissue flossing |
| Placebo comparatorConventional physiotherapy in addition to flossing without tension | Other | Placebo comparator |
Primary outcome
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.
2 secondary outcomes
Numeric rating scale change
Time frame: At baseline, after 1 week and after 4 week.
Pressure Pain Threshold change
Time frame: At baseline, after 1 week and after 4 week.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2019.
- Individual participant dataSharing planned: Undecided. This intervention could be beneficial to support or refuse the use of tissue flossing.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Cruz-Diaz, PhD principal investigator
University of Jaen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tissue flossing in people with Tennis Elbow, run by University of Jaén at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact David Cruz-Diaz, PhD (953213408, dcruz@ujaen.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient-related Tennis Elbow Questionnaire change (time frame: At baseline, after 1 week and after 4 week.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2019.