Elbow TendinopathyNCT04899375
Effect of Tissue Flossing on Pain,Function and Movement
A study testing Floss band and ACE bandage in people with Elbow Tendinopathy, run by New York Institute of Technology at 1 site in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Elbow Tendinopathy
- What is being tested?
- Floss band and ACE bandage
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2019to 23 May 2020
- 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 ≥1 month, VAS ≥3/10 (+) Tenderness to palpation (TTP) 1-3/4
Who cannot join
- Any condition that contraindicates the use of peripheral compression TTP >3/4
Trial locations and contacts
1 site in 1 country.
United States1 site
New York Institute of Technology
Old Westbury, New York, 11568
About this study
Official title: The Acute Effect of Tissue Flossing on Pain,Function,and Perception of Movement
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
Read the 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.
- Conditions
- Elbow Tendinopathy
- Being tested
- Floss band, ACE bandage
- Keywords
- Floss band; Tissue flossing; Physical therapy; Compression
- Medical subject headings
- Elbow Tendinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Floss bandDevice
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.
ACE bandageDevice
An ACE bandage is a cloth wrap used to provide compression
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Floss band; Device: ACE bandage |
What is being measured
The primary outcome is the main question the study is designed to answer.
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".
Measured: 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.
Measured: I minute
Likert Perception Scale
The Likert perception scale is the measurement of the subject's perception of change following the intervention.
Measured: I minute
Algometry
Algometry is the assessment of load-dependent tenderness at a specific anatomical site.
Measured: 3 minutes
Hand held Dynamometry
HHD is a clinical tool for assessing isometric strength
Measured: 3 minutes
Grip Strength
The assessment of hand and grip strength is a useful measure for clinicians in determining functional status.
Measured: 3 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2021
- Study start1 Sep 2019
- Primary completion1 Dec 2019
- Study completion23 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Elbow TendinopathyStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- Randomized Crossover Design
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York Institute of Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter Douris, New York Institute of Technology
- Investigators
- Peter C Douris, EdD, Principal investigator, New York Institute of Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04899375
- Sponsor's protocol ID
- NewYorkIT
- Status last verified
- May 2021
- First submitted
- 19 May 2021
- Last updated
- 24 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan
Publications
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.
PubMed 28950149Borda 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.
PubMed 28855793Arce-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).
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.
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Acute Effect of Tissue Flossing on Pain,Function,and Perception of Movement
- ClinicalTrials.gov ID
- NCT04899375
- Acronym / sponsor ID
- NewYorkIT
- Conditions
- Elbow Tendinopathy
- Keywords
- Floss band; Tissue flossing; Physical therapy; Compression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- New York Institute of TechnologyUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 1 Dec 2019 (actual)
- Study completion
- 23 May 2020 (actual)
- First posted
- 24 May 2021 (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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Randomized Crossover Design
| Arm | Type | Receives |
|---|---|---|
| One group taking part in 2 separate conditions | Experimental | Device: Floss band, Device: ACE bandageSubjects 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Elbow pain ≥1 month, VAS ≥3/10 (+) Tenderness to palpation (TTP) 1-3/4
Key exclusion criteria (1 listed)
- Any condition that contraindicates the use of peripheral compression TTP >3/4
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 |
|---|---|---|
| Floss bandTissue-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. | Device | One group taking part in 2 separate conditions |
| ACE bandageAn ACE bandage is a cloth wrap used to provide compression | Device | One group taking part in 2 separate conditions |
Primary outcome
VAS Pain Scale
Time frame: 1 minute
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
Time frame: I minute
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
Time frame: I minute
The Likert perception scale is the measurement of the subject's perception of change following the intervention.
Algometry
Time frame: 3 minutes
Algometry is the assessment of load-dependent tenderness at a specific anatomical site.
Hand held Dynamometry
Time frame: 3 minutes
HHD is a clinical tool for assessing isometric strength
Grip Strength
Time frame: 3 minutes
The assessment of hand and grip strength is a useful measure for clinicians in determining functional status.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2021.
- Results publication: PubMed 28950149Driller 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 publication: PubMed 28855793Borda 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 publicationArce-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 publicationKiefer 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.
- Individual participant dataSharing planned: No. No plan
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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.
Peter C Douris, EdD principal investigator
New York Institute of Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Floss band and ACE bandage in people with Elbow Tendinopathy, run by New York Institute of Technology at 1 site in United States.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 24 May 2021. 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 United States. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VAS Pain Scale (time frame: 1 minute). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04899375, which also lists 4 linked publications.
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 24 May 2021.