Clinical trial NCT04899375: 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
Overall status: COMPLETED
Phase: NA
Conditions: Elbow Tendinopathy
Keywords: Floss band; Tissue flossing; Physical therapy; Compression
Lead sponsor: New York Institute of Technology
Sponsor class: OTHER
First posted: 2021-05-24
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Randomized Crossover Design
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: VAS Pain Scale
timeFrame: 1 minute
measure: SF-MPQ 2
timeFrame: I minute
measure: Likert Perception Scale
timeFrame: I minute
measure: Algometry
timeFrame: 3 minutes
measure: Hand held Dynamometry
timeFrame: 3 minutes
measure: Grip Strength
timeFrame: 3 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Old Westbury
country: United States
facility: New York Institute of Technology
state: New York
Study officials:
affiliation: New York Institute of Technology
name: Peter C Douris, EdD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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).
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.