An interventional study of Floss Band Group (FBG) and Mobilization with Movement (MWM) Group in Healthy Athlete, Shoulder Mobility and Musculoskeletal Health, sponsored by Federal University of Paraíba. Not yet recruiting at 1 site in Brazil. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-09-25.
Sponsored by Federal University of Paraíba · Not applicable, Interventional, and Basic science
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
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.
Exclusion Criteria:
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 conducted at baseline and immediately post-intervention, including shoulder range of motion using a digital inclinometer, perception of movement fluency using a Visual Analogue Scale (VAS), and sport-specific performance tests (One-arm Seated Shot Put Test and Functional Throwing Performance Index).
Other: Mobilization with Movement (MWM) Group
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 perform sport-specific movements (spike and serve) for 2 minutes. Following the completion of the compression period, the band will be removed. Assessments will be conducted at baseline and immediately post-intervention, including shoulder range of motion using a digital inclinometer, perception of movement fluency using a Visual Analogue Scale (VAS), and sport-specific performance tests (One-arm Seated Shot Put Test and Functional Throwing Performance Index).
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 perform sport-specific movements (spike and serve) for 2 minutes. Following the completion of the compression period, the band will be removed. Assessments will be conducted at baseline and immediately post-intervention, including shoulder range of motion using a digital inclinometer, perception of movement fluency using a Visual Analogue Scale (VAS), and sport-specific performance tests (One-arm Seated Shot Put Test and Functional Throwing Performance Index).
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 conducted at baseline and immediately post-intervention, including shoulder range of motion using a digital inclinometer, perception of movement fluency using a Visual Analogue Scale (VAS), and sport-specific performance tests (One-arm Seated Shot Put Test and Functional Throwing Performance Index).
Shoulder Range of Motion - External Rotation
Glenohumeral external rotation (dominant shoulder) will be measured using the Baseline® Digital Inclinometer. The participant will lie in the supine position with the shoulder abducted to 90°, elbow flexed to 90°, and forearm in neutral. The inclinometer will be placed on the anterior mid-forearm, and the participant will perform active external rotation. Three measurements will be taken, and the mean value will be calculated for analysis.
Time frame: Baseline (prior to intervention, Day 1) and post-intervention (Day 1)
Shoulder Range of Motion - Internal Rotation, Flexion, Abduction, Horizontal Abduction
Internal rotation: same supine position, inclinometer on posterior mid-forearm. Flexion and abduction: seated with hips, knees, and ankles at 90° flexion; inclinometer on anterior humerus for flexion, lateral mid-humerus for abduction. Horizontal abduction: supine, shoulder 90° abduction, 90° external rotation, elbow 90° flexion; inclinometer on anterior mid-humerus. Three measurements per movement will be recorded and averaged.
Time frame: Baseline (prior to intervention, Day 1) and post-intervention (Day 1)
Functional Performance - One-arm Seated Single Arm Shot Put Test (OSP)
Participants will be seated with back against a wall, knees flexed, feet on the floor. The non-tested arm will be positioned on the chest or alongside the body. Participants will throw a 3kg medicine ball overhead, simulating a spike/serve, over a 10 m marked distance. Two submaximal familiarization trials will be performed, followed by three attempts with 1-minute rest intervals. The mean distance of the three attempts will be calculated.
Time frame: Baseline (prior to intervention, Day 1) and post-intervention (Day 1)
Functional Throwing Performance Index (FTPI)
Participants will stand 4.6 meters from a 30.5 × 30.5 cm target on a wall at 1.22 m height. Using a rubber ball (\~50.8 cm circumference), participants will throw toward the target, catch the rebound, and repeat for three 30-second trials. Eight warm-up throws will be performed prior. FTPI = number of successful hits ÷ total throws.
Time frame: Baseline (prior to intervention, Day 1) and post-intervention (Day 1)
Perceived Movement Fluency (VAS)
Participants will rate their subjective perception of shoulder movement fluency during spike/serve on a 10 cm visual analogue scale (0 = "stiff/irregular movement," 10 = "completely fluid/smooth"). The distance from the left end of the line to the participant's mark will be recorded as the final score.
Time frame: Immediately post-intervention (Day 1)
Plan to share: Yes — Individual participant data (IPD) collected in this study, including de-identified measurements of shoulder range of motion, functional performance tests, and perceived movement fluency, will be made available to other researchers. Data dictionaries describing each variable, coding, and units will also be provided. Sharing will occur in accordance with participant consent, ethical approvals, and data privacy regulations, after the publication of the main study results.
Supporting information: Study protocol, Sap, Analytic code
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Federal University of Paraíba