Immediate Effects of Flossband and Mobilization With Movement on Shoulder Mobility in Volleyball Athletes

Official title

Comparison of the Immediate Effect of Flossband and Mobilization With Movement on Shoulder Mobility in Volleyball Athletes: A Randomized Clinical Trial

Overview

The goal of this clinical trial is to learn if Floss Band application works as effectively as mobilization with movement (MWM) to improve shoulder mobility in volleyball athletes. It will also explore whether these techniques affect athletes' perception of movement fluency and sport-specific performance. The main questions it aims to answer are: Does Floss Band application immediately improve shoulder range of motion in volleyball athletes? Does Floss Band application change the perception of movement fluency compared to MWM? Does Floss Band application impact sport-specific performance tests compared to MWM? Participants will: Be randomly assigned to receive either Floss Band or mobilization with movement Have their shoulder mobility, perception of movement, and sport performance tested before and immediately after the intervention

Detailed description

Overhead sports such as volleyball demand repetitive, high-velocity arm movements that predispose athletes to musculoskeletal adaptations, especially in the glenohumeral joint. Among these, glenohumeral internal rotation deficit (GIRD) is a frequent finding, typically associated with posterior capsular tightness and muscular adaptations. This condition has been linked to decreased shoulder performance and a greater risk of overuse injuries.

Conservative approaches are essential for preserving mobility and reducing injury risk in overhead athletes. Mobilization with movement (MWM) is a well-established manual therapy intervention, combining therapist-applied accessory glenohumeral mobilization with the athlete's active shoulder motion. Evidence supports its capacity to produce immediate improvements in range of motion and sensorimotor control.

In contrast, the use of compressive elastic bands, or Floss Bands, represents a more recent strategy in rehabilitation. Proposed mechanisms include transient ischemia followed by reperfusion, improved soft tissue gliding, neuromuscular activation, and increased proprioceptive input. Although Floss Band applications have gained popularity, robust evidence on their effects in overhead athletes is still limited.

The current randomized, controlled, double-blind equivalence trial aims to compare the immediate effects of Floss Band application with MWM on shoulder mobility in volleyball athletes. The equivalence design was selected because both interventions are hypothesized to provide similar clinical benefits, and the study seeks to determine whether the novel approach (Floss Band) is not inferior to the well-established MWM.

Intervention Procedures Participants will undergo two assessments: baseline and immediately post-intervention. Interventions will be delivered by researchers trained and standardized in both techniques.

Floss Band Group (FBG): The participant will be seated with the shoulder positioned at 90° abduction. The researcher will apply a compressive elastic band (100% polymer gel, 210 cm circumference, 5 cm width, 1.3 mm thickness). The first anchor will be placed two finger-widths medial to the acromion, and the band will be wrapped circumferentially around the shoulder until the material length is exhausted, securing the final anchor. During the two-minute application, the participant will perform sport-specific movements (e.g., spike and serve gestures). After the time limit, the band will be removed.

Mobilization with Movement Group (MWM): The participant will remain seated with back support and hips, knees, and ankles flexed at 90°. The therapist will stabilize the scapula with one hand, while the other hand will apply a posterolateral glide to the humeral head during active arm elevation in the scapular plane. The protocol will consist of three sets of 10 repetitions, with one-minute rest intervals between sets.

Data Management and Quality Assurance All assessors will undergo standardized training to ensure consistency across evaluations. Prior to trial initiation, pilot testing of procedures will be conducted. Data will be collected using predefined case report forms and transferred into a secure electronic database.

Quality assurance measures will include:

Data validation: Automated checks for range, completeness, and logical consistency between variables.

Source data verification: Cross-checks of electronic entries with original case report forms by an independent monitor.

Auditing: Periodic audits conducted by external staff not involved in data collection or intervention delivery.

Standard Operating Procedures (SOPs): Detailed instructions for participant recruitment, intervention delivery, data entry, adverse event reporting, and change management.

Data dictionary: Comprehensive description of variables, coding schemes, and reference values to maintain consistency and transparency.

Sample Size and Statistical Plan The trial is powered to detect equivalence between interventions in the primary outcome (shoulder ROM). A total of 36 athletes will be randomized equally across groups, stratified by sex and age. Analyses will follow the intention-to-treat principle. Between-group differences will be adjusted for baseline values, and 95% confidence intervals will be calculated to test equivalence margins. Missing data will be addressed with multiple imputation methods.

Expected Contribution By comparing an innovative compressive technique with an established manual therapy, this study is designed to provide high-quality evidence on immediate intervention effects in volleyball athletes. The results are expected to inform clinicians, coaches, and sports medicine professionals on effective strategies for optimizing shoulder function and preventing injury in overhead sports.

Interventions

• Device Floss Band Group (FBG)
  Participants in this arm will perform the standardized Floss Band (FBG) protocol. While seated with the shoulder at 90° abduction, the researcher will apply a compressive elastic band made of 100% polymer gel (T.P.E), measuring 210 cm in length, 5 cm in width, and 1.3 mm in thickness. The first anchor is placed two fingers medial to the acromion, and the band is wrapped around the shoulder until the second anchor at the end of the band is fixed. After the application, the participant will perfor
• Other Mobilization with Movement (MWM) Group
  Participants in this arm will perform the standardized Mobilization with Movement (MWM) protocol. While seated in a chair with back support and hips, knees, and ankles at 90° flexion, the researcher will stabilize the scapula with one hand and apply a posterolateral glide to the anterior humeral head with the other hand during active shoulder elevation in the scapular plane. The intervention consists of 3 sets of 10 repetitions, with a 1-minute rest interval between sets. Assessments will be con

Primary outcome measures

• Shoulder Range of Motion - External Rotation [Time frame: Baseline (prior to intervention, Day 1) and post-intervention (Day 1)]
• Shoulder Range of Motion - Internal Rotation, Flexion, Abduction, Horizontal Abduction [Time frame: Baseline (prior to intervention, Day 1) and post-intervention (Day 1)]

Secondary outcome measures (3)

• Functional Performance - One-arm Seated Single Arm Shot Put Test (OSP) [Time frame: Baseline (prior to intervention, Day 1) and post-intervention (Day 1)]
• Functional Throwing Performance Index (FTPI) [Time frame: Baseline (prior to intervention, Day 1) and post-intervention (Day 1)]
• Perceived Movement Fluency (VAS) [Time frame: Immediately post-intervention (Day 1)]

Eligibility criteria

Inclusion criteria

• Age between 18 and 50 years.
• Male or female volleyball athletes (indoor or beach), at amateur or professional level.
• Regular training routine of at least two sessions per week.
• No shoulder pain at the time of testing or during the previous three months.

Exclusion criteria

• History of shoulder surgery, structural shoulder injuries (e.g., fractures, labrum tear), or recurrent glenohumeral dislocation.
• Skin disorders contraindicating the intervention, including active dermatitis, inflammatory-phase psoriasis, cutaneous infections (e.g., folliculitis), open wounds, burns, eczema, or hypersensitivity in the shoulder region.
• Vascular disorders contraindicating the intervention, including history or diagnosis of deep vein thrombosis, symptomatic varicose veins, peripheral arterial disease, lymphedema, or advanced chronic venous insufficiency.
• Other conditions contraindicating intervention: peripheral neuropathies with significant sensory loss, presence of a pacemaker in the region of band application, known allergy to elastic band material, or pain during shoulder movement at assessment.
• Development of shoulder or elbow injuries during the study, especially requiring surgical intervention.
• Participants who voluntarily withdraw from the study at any time.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Basic science

Study locations

Brazil · 1 center

• Federal University of Paraíba — Igarapé-Açu

Publications

• Young WK, Briner W, Dines DM. Epidemiology of Common Injuries in the Volleyball Athlete. Curr Rev Musculoskelet Med. 2023 Jun;16(6):229-234. doi: 10.1007/s12178-023-09826-2. Epub 2023 Apr 4. PMID 37014607
• Wassinger CA, Myers JB, Gatti JM, Conley KM, Lephart SM. Proprioception and throwing accuracy in the dominant shoulder after cryotherapy. J Athl Train. 2007 Jan-Mar;42(1):84-9. PMID 17597948
• Wang S, Zeng J, Mani R, Chapple CM, Ribeiro DC. The immediate effects of mobilization with movement on shoulder range of motion and pain in patients with rotator cuff-related shoulder pain: A randomized controlled trial (Evolution Trial). Braz J Phys Ther. 2024 Nov-Dec;28(6):101145. doi: 10.1016/j.bjpt.2024.101145. Epub 2024 Nov 20. PMID 39571379
• Tozzo MC, Ansanello W, Martins J, Zatiti SCA, de Oliveira AS. Inclinometer Reliability for Shoulder Ranges of Motion in Individuals With Subacromial Impingement Syndrome. J Manipulative Physiol Ther. 2021 Mar;44(3):236-243. doi: 10.1016/j.jmpt.2020.12.001. Epub 2021 Apr 27. PMID 33926742
• Tooth C, Gofflot A, Schwartz C, Croisier JL, Beaudart C, Bruyere O, Forthomme B. Risk Factors of Overuse Shoulder Injuries in Overhead Athletes: A Systematic Review. Sports Health. 2020 Sep/Oct;12(5):478-487. doi: 10.1177/1941738120931764. Epub 2020 Aug 6. PMID 32758080
• Tagliarini GO, Junior JRS, Barbosa GMP, Secchi LLB. Performance, Test-retest Reliability, and Measurement Error of the Upper Limb Seated Shot Put Test According to Different Positions of Execution. Int J Sports Phys Ther. 2023 Jun 1;V18(3):698-706. doi: 10.26603/001c.75227. eCollection 2023. PMID 37425121
• Schwank A, Blazey P, Asker M, Moller M, Hagglund M, Gard S, Skazalski C, Haugsbo Andersson S, Horsley I, Whiteley R, Cools AM, Bizzini M, Ardern CL. 2022 Bern Consensus Statement on Shoulder Injury Prevention, Rehabilitation, and Return to Sport for Athletes at All Participation Levels. J Orthop Sports Phys Ther. 2022 Jan;52(1):11-28. doi: 10.2519/jospt.2022.10952. PMID 34972489
• Satpute K, Reid S, Mitchell T, Mackay G, Hall T. Efficacy of mobilization with movement (MWM) for shoulder conditions: a systematic review and meta-analysis. J Man Manip Ther. 2022 Feb;30(1):13-32. doi: 10.1080/10669817.2021.1955181. Epub 2021 Aug 1. PMID 34334099

Identifiers

NCT: NCT07192003 · 7812025

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗