Healthy AthleteNCT07192003
Immediate Effects of Flossband and Mobilization With Movement on Shoulder Mobility in Volleyball Athletes
A study testing Floss Band Group (FBG) and Mobilization with Movement (MWM) Group in people with Healthy Athlete and Shoulder Mobility, run by Federal University of Paraíba at 1 site in Brazil.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Athlete, Shoulder Mobility, Musculoskeletal Health
- What is being tested?
- Floss Band Group (FBG) and Mobilization with Movement (MWM) Group
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteBrazil
- Study dates
- 20 Oct 2025to 18 Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site
Federal University of Paraíba
Igarapé-Açu, Pará, 58051-900
Valéria Oliveira, PhD, +5587999524987, valeria.mayaly@gmail.com
Danilo Kamonseki, PhD, +5516993778695, danilo.kamonseki@academico.ufpb.br
About this study
Official title: Comparison of the Immediate Effect of Flossband and Mobilization With Movement on Shoulder Mobility in Volleyball Athletes: A Randomized Clinical Trial
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:
Read more
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
Read the 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.
- Conditions
- Healthy Athlete, Shoulder Mobility, Musculoskeletal Health
- Being tested
- Floss Band Group (FBG), Mobilization with Movement (MWM) Group
- Keywords
- Range of Motion, Shoulder, Sports, Physical Therapy Modalities, Mobilization with Movement, Volleyball
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Floss Band Group (FBG)Device
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).
Mobilization with Movement (MWM) GroupOther
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).
| Study group | Role | What they receive |
|---|---|---|
| Mobilization with Movement (MWM) Group | Active comparator | 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). Receives: Other: Mobilization with Movement (MWM) Group |
| Floss Band Group (FBG) | Experimental | 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). Receives: Device: Floss Band Group (FBG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline (prior to intervention, Day 1) and post-intervention (Day 1)
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: Immediately post-intervention (Day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2025
- Study start20 Oct 2025 (estimated)
- Primary completion18 Apr 2026 (estimated)
- Study completion18 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (27)Papers the sponsor has linked to this study.
- Other trials for Healthy AthleteStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of Paraíba
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Valéria Mayaly Alves de Oliveira, Federal University of Paraíba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07192003
- Sponsor's protocol ID
- 7812025
- Status last verified
- Sep 2025
- First submitted
- 9 Sep 2025
- Last updated
- 25 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
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.
PubMed 37014607Wassinger 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.
PubMed 17597948Wang 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.
PubMed 39571379Tozzo 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.
PubMed 33926742Tooth 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.
PubMed 32758080Tagliarini 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.
PubMed 37425121Schwank 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.
PubMed 34972489Satpute 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.
PubMed 34334099Rose MB, Noonan T. Glenohumeral internal rotation deficit in throwing athletes: current perspectives. Open Access J Sports Med. 2018 Mar 19;9:69-78. doi: 10.2147/OAJSM.S138975. eCollection 2018.
PubMed 29593438Pascoal AG, Ribeiro A, Infante J. Scapular Resting Posture and Scapulohumeral Rhythm Adaptations in Volleyball Players: Implications for Clinical Shoulder Assessment in Athletes. Sports (Basel). 2023 Jun 8;11(6):114. doi: 10.3390/sports11060114.
PubMed 37368564Myers JB, Oyama S, Goerger BM, Rucinski TJ, Blackburn JT, Creighton RA. Influence of humeral torsion on interpretation of posterior shoulder tightness measures in overhead athletes. Clin J Sport Med. 2009 Sep;19(5):366-71. doi: 10.1097/JSM.0b013e3181b544f6.
PubMed 19741307Mine K, Nakayama T, Milanese S, Grimmer K. Effectiveness of Stretching on Posterior Shoulder Tightness and Glenohumeral Internal-Rotation Deficit: A Systematic Review of Randomized Controlled Trials. J Sport Rehabil. 2017 Jul;26(4):294-305. doi: 10.1123/jsr.2015-0172. Epub 2016 Aug 24.
PubMed 27632891Manske R, Wilk KE, Davies G, Ellenbecker T, Reinold M. Glenohumeral motion deficits: friend or foe? Int J Sports Phys Ther. 2013 Oct;8(5):537-53.
PubMed 24175137Lin DJ, Wong TT, Kazam JK. Shoulder Injuries in the Overhead-Throwing Athlete: Epidemiology, Mechanisms of Injury, and Imaging Findings. Radiology. 2018 Feb;286(2):370-387. doi: 10.1148/radiol.2017170481.
PubMed 29356641Larrivee S, Balg F, Leonard G, Bedard S, Tousignant M, Boissy P. Wrist-Based Accelerometers and Visual Analog Scales as Outcome Measures for Shoulder Activity During Daily Living in Patients With Rotator Cuff Tendinopathy: Instrument Validation Study. JMIR Rehabil Assist Technol. 2019 Dec 3;6(2):e14468. doi: 10.2196/14468.
PubMed 31793896
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Immediate Effect of Flossband and Mobilization With Movement on Shoulder Mobility in Volleyball Athletes: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07192003
- Acronym / sponsor ID
- 7812025
- Conditions
- Healthy Athlete, Shoulder Mobility, Musculoskeletal Health
- Keywords
- Range of Motion, Shoulder, Sports, Physical Therapy Modalities, Mobilization with Movement, Volleyball
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Federal University of ParaíbaUniversity, hospital or other
- Study start
- 20 Oct 2025 (estimated)
- Primary completion
- 18 Apr 2026 (estimated)
- Study completion
- 18 Apr 2026 (estimated)
- First posted
- 25 Sep 2025 (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 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mobilization with Movement (MWM) Group | Active comparator | Other: Mobilization with Movement (MWM) GroupParticipants 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). |
| Floss Band Group (FBG) | Experimental | 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). |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
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 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). | Device | Floss Band Group (FBG) |
| Mobilization with Movement (MWM) GroupParticipants 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 |
Primary outcome
Shoulder Range of Motion - External Rotation
Time frame: Baseline (prior to intervention, Day 1) and post-intervention (Day 1)
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.
Shoulder Range of Motion - Internal Rotation, Flexion, Abduction, Horizontal Abduction
Time frame: Baseline (prior to intervention, Day 1) and post-intervention (Day 1)
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.
3 secondary outcomes
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2025.
- Results publication: PubMed 37014607Young 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.
- Results publication: PubMed 17597948Wassinger 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.
- Results publication: PubMed 39571379Wang 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.
- Results publication: PubMed 33926742Tozzo 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.
- Results publication: PubMed 32758080Tooth 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.
- Results publication: PubMed 37425121Tagliarini 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.
- Results publication: PubMed 34972489Schwank 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.
- Results publication: PubMed 34334099Satpute 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.
- Results publication: PubMed 29593438Rose MB, Noonan T. Glenohumeral internal rotation deficit in throwing athletes: current perspectives. Open Access J Sports Med. 2018 Mar 19;9:69-78. doi: 10.2147/OAJSM.S138975. eCollection 2018.
- Results publication: PubMed 37368564Pascoal AG, Ribeiro A, Infante J. Scapular Resting Posture and Scapulohumeral Rhythm Adaptations in Volleyball Players: Implications for Clinical Shoulder Assessment in Athletes. Sports (Basel). 2023 Jun 8;11(6):114. doi: 10.3390/sports11060114.
- Results publication: PubMed 19741307Myers JB, Oyama S, Goerger BM, Rucinski TJ, Blackburn JT, Creighton RA. Influence of humeral torsion on interpretation of posterior shoulder tightness measures in overhead athletes. Clin J Sport Med. 2009 Sep;19(5):366-71. doi: 10.1097/JSM.0b013e3181b544f6.
- Results publication: PubMed 27632891Mine K, Nakayama T, Milanese S, Grimmer K. Effectiveness of Stretching on Posterior Shoulder Tightness and Glenohumeral Internal-Rotation Deficit: A Systematic Review of Randomized Controlled Trials. J Sport Rehabil. 2017 Jul;26(4):294-305. doi: 10.1123/jsr.2015-0172. Epub 2016 Aug 24.
- Individual participant dataSharing planned: 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.
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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.
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 Group (FBG) and Mobilization with Movement (MWM) Group in people with Healthy Athlete and Shoulder Mobility, run by Federal University of Paraíba at 1 site in Brazil.
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 4 inclusion and 6 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: opening soon, as of the sponsor's last update on 25 Sep 2025. 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 Brazil. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Valéria Oliveira, PhD (+5587999524987, valeria.mayaly@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Shoulder Range of Motion - External Rotation (time frame: Baseline (prior to intervention, Day 1) and post-intervention (Day 1)). The study lists 2 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 NCT07192003, which also lists 27 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 25 Sep 2025.