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Effect of Tissue Flossing on Pain,Function and Movement

Primary Purpose

Elbow Tendinopathy

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Floss band
ACE bandage
Sponsored by
New York Institute of Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Elbow Tendinopathy focused on measuring Floss band; Tissue flossing; Physical therapy; Compression

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • New York Institute of Technology

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

One group taking part in 2 separate conditions

Arm Description

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.

Outcomes

Primary Outcome Measures

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".
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.
Likert Perception Scale
The Likert perception scale is the measurement of the subject's perception of change following the intervention.
Algometry
Algometry is the assessment of load-dependent tenderness at a specific anatomical site.
Hand held Dynamometry
HHD is a clinical tool for assessing isometric strength
Grip Strength
The assessment of hand and grip strength is a useful measure for clinicians in determining functional status.

Secondary Outcome Measures

Full Information

First Posted
May 19, 2021
Last Updated
May 19, 2021
Sponsor
New York Institute of Technology
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1. Study Identification

Unique Protocol Identification Number
NCT04899375
Brief Title
Effect of Tissue Flossing on Pain,Function and Movement
Official Title
The Acute Effect of Tissue Flossing on Pain,Function,and Perception of Movement
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
September 1, 2019 (Actual)
Primary Completion Date
December 1, 2019 (Actual)
Study Completion Date
May 23, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
New York Institute of Technology

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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
Detailed Description
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. This modality represents a contemporary strategy that has not been fully investigated with respect to performance-enhancement and rehabilitative utility.1-5 This approach was popularized by Starrett et al.(2013) with the introduction of floss-band compression for the improvement of joint specific range of motion (ROM).6 Floss bands (7'x2") are applied to site-specific muscle groups and, or joints with treatment typically lasting 1 to 3 minutes. Initial support has favored anecdote, though has a growing body of support, and carries a postulated mechanism relative to deep-tissue compression and/or reperfusion of blood.1 Despite minimal empirical evidence, this modality has gained popularity in both the sport and rehabilitation fields.1-5 There appears to be a gap in the knowledge in respect to the effectiveness of tissue-flossing Initial investigations demonstrate positive effects on ROM, jump-performance, pain, function and strength in athletic populations.1-5 Driller et al. (2017) utilized a tissue-floss technique at the ankle, to provide compression and partial vascular occlusion in recreational athletes. Performance metrics were measured for weight-bearing lunge test (WBLT), dorsi- (DF) and plantar-flexion (PF) ROM and single-leg vertical jump test for both height and velocity. The data collected from this study revealed significant improvements (p<0.01), albeit a small effect size, across all performance variables.1 Subsequently, Driller et al. (2017) investigated the time-course of tissue-flossing at the ankle, in recreational athletes.2 Performance metrics in this investigation included WBLT, counter-movement jump and 15m sprint test. Significant improvements (p<0.05) were seen, following tissue-flossing, in WBLT at all time-points, indicating a potential utility for up to 45-minutes following application. Along with a potential performance benefit, case-studies3, 4 have presented tissue-flossing as an adjunct to conventional physical therapy. Borda et al. (2016) demonstrated efficacy in a single subject with diagnosed chronic, left Achilles tendinopathy.3 The subject (age 14), a female athlete, presented, following a 6-week course of physical therapy, with posterior ankle pain, visual analog scale (VAS) 8/10, and impaired lower extremity function, 66/80, determined by the Lower Extremity Function Scale (LEFS). Following the intervention, the patient reported a VAS of 0/10 and scored a 79/80 on the LEFS. Additionally, Arce-Esquivel et al. (2018) demonstrated effective use, in a single subject case-report, for the treatment of functional deficits and pain, associated with Keinböck's disease.4 Following 6-weeks of treatment, the patient's Wrist Hand Disability Index (WHDI) score had increased 45% from 3.3 (week 1) to 4.8 (week 6) and pain had decreased 88%, from 5.8cm/10cm (week 1) to 0.7cm/10cm (week 6). More recently, Brandenburg et al. (2018) examined the effect of tissue-flossing on imposed delayed-onset muscle soreness (DOMS) in the upper extremity. DOMS is defined as a functional muscle disorder that results from overexertion.8 Commonly, DOMS results in peak symptoms 48-72 hours post-exercise and reflects muscular pain, edema, decreased strength, power and ROM, with a concurrent neuromuscular deficit to the affected area.9-12 The investigation7 collected pain scores, via 10 cm VAS, at both 24- and 48-hours. Findings demonstrate significant improvement at both 24- (p=0.036) and 48-hours (p=0.035). The aggregate of these data suggest that tissue-flossing may be a viable supplement to clinical management of some musculoskeletal disorders. However, further research including controlled clinical trials and longitudinal observations, is warranted to further elucidate quantifiable functional outcomes and clinical application strategies associated with this modality. In athletes, the upper extremity, specifically the elbow complex, is subject to an array of injurious processes.13 Patients often report local pain, edema, decreased strength, power and ROM, as well as, neuromuscular deficits.13,14 Manual therapy and compressive, counterforce orthoses are commonly used interventions in the non-surgical management of musculoskeletal ailments experienced at the elbow; following treatment patients report improved pain, functional performance and grip-strength.17,18 It is hypothesized that the proposed mechanisms of action, associated with tissue-flossing, may be beneficial as a cost-effective adjunct to conventional therapeutic exercise. Thus, the aim of the current investigation is to examine the effect of tissue-flossing on upper extremity functional performance in subjects with musculoskeletal-related complaints of pain surrounding the elbow complex.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Elbow Tendinopathy
Keywords
Floss band; Tissue flossing; Physical therapy; Compression

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Randomized Crossover Design
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
One group taking part in 2 separate conditions
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Floss band
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
ACE bandage
Intervention Description
An ACE bandage is a cloth wrap used to provide compression
Primary Outcome Measure Information:
Title
VAS Pain Scale
Description
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".
Time Frame
1 minute
Title
SF-MPQ 2
Description
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.
Time Frame
I minute
Title
Likert Perception Scale
Description
The Likert perception scale is the measurement of the subject's perception of change following the intervention.
Time Frame
I minute
Title
Algometry
Description
Algometry is the assessment of load-dependent tenderness at a specific anatomical site.
Time Frame
3 minutes
Title
Hand held Dynamometry
Description
HHD is a clinical tool for assessing isometric strength
Time Frame
3 minutes
Title
Grip Strength
Description
The assessment of hand and grip strength is a useful measure for clinicians in determining functional status.
Time Frame
3 minutes

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 ≥1 month, VAS ≥3/10 (+) Tenderness to palpation (TTP) 1-3/4 Exclusion Criteria: Any condition that contraindicates the use of peripheral compression TTP >3/4
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter C Douris, EdD
Organizational Affiliation
New York Institute of Technology
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York Institute of Technology
City
Old Westbury
State/Province
New York
ZIP/Postal Code
11568
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
No plan
Citations:
PubMed Identifier
28950149
Citation
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.
Results Reference
result
PubMed Identifier
28855793
Citation
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.
Results Reference
result
Citation
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).
Results Reference
result
Citation
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.
Results Reference
result

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Effect of Tissue Flossing on Pain,Function and Movement

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