- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07072091
- Original Trial
Focusing the Shoulder or Considering the Whole-Body in Volleyball Physiotherapy (FocusVolley)
August 11, 2025 updated by: Alex Buoite Stella, University of Trieste
Focusing the Shoulder or Considering the Whole-Body? A Randomized Controlled Trial on Physiotherapy Protocols for the Painful Shoulder in Volleyball Players
Shoulder pain can be common in overhead sports, and in particular, in volleyball.
Different physiotherapy protocols can be adopted depending on the suspected pathophysiological mechanisms.
Despite most of the protocols rely only on the shoulder district, some research suggests that treating the whole-body might produce better results as it could influence kinematic chains and correct muscle imbalances.
The aim of this study will be to compare the effects of two physiotherapy protocols (shoulder focus or whole body) compared to only education without physiotherapy.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Trieste, Italy, 34100
- Recruiting
- University of Trieste - Exercise Physiology and Kinesiology Lab
-
Contact:
- Alex Buoite Stella, PhD
- Phone Number: 0039 0403996582
- Email: abuoitestella@units.it
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- practicing volleyball for at least 5 years with a training volume of minimum 5 h/wk
Exclusion Criteria:
- history of previous surgical intervention or fractures on the shoulder or spine
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Healthy controls
A convenience sample of healthy volleyball players for cross-sectional comparison
|
|
|
Experimental: Total body physiotherapy group
Physiotherapy intervention consisting in whole body exercise and treatment
|
This intervention consists in 5 weeks of 2 x week 60 min sessions of physiotherapy consisting in active exercise performed in upper limb, trunk, and lower limb muscles, in a whole-body approach.
|
|
Active Comparator: Focus shoulder group
Physiotherapy intervention consisting in shoulder exercise and treatment
|
This intervention consists in 5 weeks of 2 x week 60 min sessions of physiotherapy consisting in active exercise performed only in the shoulder district, focusing on the trunk-arm muscles.
|
|
Other: No physiotherapy group
No physiotherapy, only education
|
Single education session providing information about posture hygiene and proper warm-up
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Isometric strength with handheld dynamometer (Newtons)
Time Frame: At enrollment and at the end of treatment at 5 weeks
|
Isometric strength during shoulder flexion, extension, external and internal rotation, bilaterally
|
At enrollment and at the end of treatment at 5 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Lateral symmetry (%)
Time Frame: At enrollement and at the end of treatment after 5 weeks
|
Lateral symmetry will be assessed as percentage between the two upper limbs for the investigated muscles (pectoralis major, latissimus dorsi, upper trapezius, middle trepezius, lower trapezius, anterior deltoid, posterior deltoid) using the tensiomyography system
|
At enrollement and at the end of treatment after 5 weeks
|
|
Time of contraction (ms)
Time Frame: At enrollement and at the end of treatment after 5 weeks
|
Time of contraction (ms), i.e. the time requiring the muscle to reach the peak of muscle displacement, will be assessed as percentage between the two upper limbs for the investigated muscles (pectoralis major, latissimus dorsi, upper trapezius, middle trepezius, lower trapezius, anterior deltoid, posterior deltoid) using the tensiomyography system
|
At enrollement and at the end of treatment after 5 weeks
|
|
Muscle belly displacement (mm)
Time Frame: At enrollement and at the end of treatment after 5 weeks
|
Muscle belly displacement (mm), i.e. the amplitude of muscle displacement, will be assessed as percentage between the two upper limbs for the investigated muscles (pectoralis major, latissimus dorsi, upper trapezius, middle trepezius, lower trapezius, anterior deltoid, posterior deltoid) using the tensiomyography system
|
At enrollement and at the end of treatment after 5 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Jones SD Jr, Safran MR. Current concepts: the hip, core and kinetic chain in the overhead athlete. J Shoulder Elbow Surg. 2024 Feb;33(2):450-456. doi: 10.1016/j.jse.2023.10.009. Epub 2023 Nov 23.
- Erkan R, Telci EA. Impact of Stabilization Exercises on Athletic Performance and Injury Risk in College Volleyball Players. Int J Sports Physiol Perform. 2025 May 13;20(7):948-957. doi: 10.1123/ijspp.2024-0348. Print 2025 Jul 1.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 20, 2025
Primary Completion (Estimated)
September 1, 2025
Study Completion (Estimated)
September 1, 2025
Study Registration Dates
First Submitted
May 30, 2025
First Submitted That Met QC Criteria
July 8, 2025
First Posted (Actual)
July 18, 2025
Study Record Updates
Last Update Posted (Actual)
August 14, 2025
Last Update Submitted That Met QC Criteria
August 11, 2025
Last Verified
August 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DSM_Fisio_SpallaPallavolo25
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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