NCT04899375

Brief Summary

The purpose of the current investigation is to examine the effect of tissue-flossing on upper extremity, pain, strength and functional performance in subjects with musculoskeletal-related complaints of pain surrounding the elbow complex

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 23, 2020

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

May 19, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 24, 2021

Completed
Last Updated

May 24, 2021

Status Verified

May 1, 2021

Enrollment Period

3 months

First QC Date

May 19, 2021

Last Update Submit

May 19, 2021

Conditions

Keywords

Floss band; Tissue flossing; Physical therapy; Compression

Outcome Measures

Primary Outcomes (6)

  • VAS Pain Scale

    The 100 millimeter VAS is a commonly employed self-completed scale for the assessment of pain in adults. The scale is scored using a ruler, by measuring the distance in millimetres, along a 100 millimetres line, from the anchor marked "no pain".

    1 minute

  • SF-MPQ 2

    The SF-MPQ 2 is a shorter version of the original McGill Pain Questionnaire. It is a multidimensional measure of pain, consisting of 2 subscales, one for sensory change and one for affective change.

    I minute

  • Likert Perception Scale

    The Likert perception scale is the measurement of the subject's perception of change following the intervention.

    I minute

  • Algometry

    Algometry is the assessment of load-dependent tenderness at a specific anatomical site.

    3 minutes

  • Hand held Dynamometry

    HHD is a clinical tool for assessing isometric strength

    3 minutes

  • Grip Strength

    The assessment of hand and grip strength is a useful measure for clinicians in determining functional status.

    3 minutes

Study Arms (1)

One group taking part in 2 separate conditions

EXPERIMENTAL

Subjects will be randomly assigned to either group A or B. Session 1 will serve to familiarize all participants with the battery of tests including the 100 mm VAS, Short-form Mcgill Pain Questionnaire (SF-MPQ), Likert perception scale adapted from Kiefer et al. (2017), algometry, manual muscle testing, assessed via hand-held dynamometer (HHD), and grip strength assessed via hydraulic hand dynamometer; subjects will also be instructed in the AROM protocol. Familiarization will be conducted a minimum of 24 hours prior to the first condition. There will be a minimum washout period of 1 week to reduce both order and carry-over effects. Only the principal investigator will be abreast to the order of intervention, sufficiently blinding the raters. Prior to each trial, participants will be instructed to refrain from resistance training for a minimum of 48 hours and to abstain from the use of stimulants or analgesic medication for a minimum of 6 hours prior to reporting to the lab.

Device: Floss bandDevice: ACE bandage

Interventions

Tissue-flossing, is the use of an elastic band to provide compression on soft-tissue and joints whilst performing active and, or passive range of motion.

One group taking part in 2 separate conditions

An ACE bandage is a cloth wrap used to provide compression

One group taking part in 2 separate conditions

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Elbow pain ≥1 month, VAS ≥3/10 (+) Tenderness to palpation (TTP) 1-3/4

You may not qualify if:

  • Any condition that contraindicates the use of peripheral compression TTP \>3/4

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New York Institute of Technology

Old Westbury, New York, 11568, United States

Location

Related Publications (4)

  • Driller M, Mackay K, Mills B, Tavares F. Tissue flossing on ankle range of motion, jump and sprint performance: A follow-up study. Phys Ther Sport. 2017 Nov;28:29-33. doi: 10.1016/j.ptsp.2017.08.081. Epub 2017 Aug 24.

  • Borda J, Selhorst M. The use of compression tack and flossing along with lacrosse ball massage to treat chronic Achilles tendinopathy in an adolescent athlete: a case report. J Man Manip Ther. 2017 Feb;25(1):57-61. doi: 10.1080/10669817.2016.1159403. Epub 2016 May 30.

  • Arce-Esquivel AA, Cage SA, Warner BJ, Stevenson P. Flossing bands to treat keinböck's disease in a collegiate men's basketball player: a case report. International Physical Medicine & Rehabilitation Journal. 2018;3(2).

    RESULT
  • Kiefer BN, Lemarr KE, Enriquez CC, Tivener KA, Daniel T. A Pilot Study: Perceptual Effects of the Voodoo Floss Band on Glenohumeral Flexibility. International Journal of Athletic Therapy and Training. 2017;22(4):29-33.

    RESULT

MeSH Terms

Conditions

Elbow Tendinopathy

Condition Hierarchy (Ancestors)

TendinopathyMuscular DiseasesMusculoskeletal DiseasesElbow InjuriesArm InjuriesWounds and InjuriesTendon Injuries

Study Officials

  • Peter C Douris, EdD

    New York Institute of Technology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Randomized Crossover Design
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 19, 2021

First Posted

May 24, 2021

Study Start

September 1, 2019

Primary Completion

December 1, 2019

Study Completion

May 23, 2020

Last Updated

May 24, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

No plan

Locations