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Status unknownNCT03834077FLOSSUpdated Feb 7, 2019

Tissue Flossing in Tennis Elbow Patients

An interventional study of Tissue flossing and Placebo comparator in Tennis Elbow, sponsored by University of Jaén. Status unknown at 1 site in Spain. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2019-02-07.

Sponsored by University of Jaén · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Feb 2019), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Tennis Elbow

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Keywords

  • physiotherapy
03

In context

Tennis Elbow

297 studies on the registry are indexed under Tennis Elbow; 63 are open to participants now.

This study's planned enrollment of 50 is close to the median of 50 across 263 interventional studies indexed under Tennis Elbow.

Browse Tennis Elbow studies →

Lead sponsor

University of Jaén is the lead sponsor of 81 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Upper limb fractures, surgery or concomitant disease.
  • Red flags presence.
  • Mental disorders.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Care provider, Investigator, Outcomes assessor)
Enrollment
50 participants (estimated)

Study arms

  • Experimental
    Tissue flossing

    Conventional physiotherapy consisted in electrotherapy and stretching in addition to tissue flossing.

    Other: Tissue flossing

  • Placebo comparator
    Placebo comparator

    Conventional physiotherapy consisted in electrotherapy and stretching in addition with tissue flossing without tension.

    Other: Placebo comparator

Interventions

  • OtherTissue flossing

    Electrotherapy (transcutaneous electrical nerve stimulation) and Ultrasound in addition to tissue flossing.

  • OtherPlacebo comparator

    Conventional physiotherapy in addition to flossing without tension

06

What researchers measure

Primary outcomes

  1. Patient-related Tennis Elbow Questionnaire change

    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 outcomes

  1. Numeric rating scale change

    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.

  2. Pressure Pain Threshold change

    Determine the pain free pression with a validated instrument

    Time frame: At baseline, after 1 week and after 4 week.

07

Study locations

1 site
  • University of Jaen
    Jaén, 23071, Spain
08

References and documents

Individual participant data

Plan to share: Undecided — This intervention could be beneficial to support or refuse the use of tissue flossing.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Feb 2019; primary completion for Mar 2019, 1 month later.

Of 147 non-industry interventional studies with no phase under Tennis Elbow, half reached primary completion within 8 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 24. This study's planned 1 month is below that.

Counting every sponsor, half of 150 studies reached it within 9 months; a quarter within 5 and three quarters within 22.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 4, 2019
First posted
Feb 7, 2019
StartEst.
Feb 20, 2019
Primary completionEst.
Mar 28, 2019
CompletionEst.
Apr 10, 2019
Last update
Feb 7, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 7, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03834077
Lead sponsor
University of Jaén
Responsible party
DAVID CRUZ DÍAZ (Vice Dean, University of Jaén) — Principal investigator
First posted
Feb 7, 2019
Start date
Feb 20, 2019 (estimated)
Primary completion
Mar 28, 2019 (estimated)
Completion
Apr 10, 2019 (estimated)
Last update
Feb 7, 2019

Study contacts

David Cruz-Diaz, PhD
Contact
dcruz@ujaen.es
953213408
David Cruz-Diaz, PhD
principal investigator · University of Jaen

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.

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