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Effectiveness of a Standardised Stabilisation Exercise Protocol in Volleyball Players With Non-traumatic Shoulder Instability 22 Randomized Exercise-Based
Clinical Trial NCT07400900 is an interventional study for Shoulder Instability and is currently not yet recruiting. Enrollment is planned to begin on 1 March 2026 and continue until the study accrues 22 participants. Led by Universidad Francisco de Vitoria, this study is expected to complete by 1 June 2026. The latest data from ClinicalTrials.gov was last updated on 13 February 2026.
Brief Summary
This randomized controlled clinical trial aims to evaluate the effectiveness of a standardized shoulder stabilization exercise program in amateur volleyball players diagnosed with atraumatic shoulder instability. Shoulder pain is one of the most prevalent musculoskeletal complaints, affecting up to two-thirds of the general population at some point in life and frequently leading to long-term symptoms, functional limi...Show More
Detailed Description
Atraumatic shoulder instability is a prevalent condition among athletes who perform repetitive overhead movements, particularly volleyball players. The biomechanical demands of serving, spiking, and blocking expose the glenohumeral joint to repeated high-velocity rotational forces, which may contribute to impaired neuromuscular control, altered proprioception, and insufficient dynamic stabilization. These factors can...Show More
Official Title
Effectiveness of a Standardised Stabilisation Exercise Protocol in Volleyball Players With Non-traumatic Shoulder Instability
Conditions
Shoulder InstabilityOther Study IDs
- VolleyShoulder
NCT ID Number
Start Date (Actual)
2026-03-01
Last Update Posted
2026-02-13
Completion Date (Estimated)
2026-06-01
Enrollment (Estimated)
22
Study Type
Interventional
PHASE
N/A
Status
Not yet recruiting
Keywords
voleyball
shoulder pain
instability
exercise
Derby Shoulder Instability Rehabilitation Programme
randomized controlled trial
overhead
shoulder pain
instability
exercise
Derby Shoulder Instability Rehabilitation Programme
randomized controlled trial
overhead
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Double
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
No InterventionControl Wait and see during 8 weeks | N/A |
ExperimentalIntervention group Participants assigned to the intervention group will complete the Derby Shoulder Instability Rehabilitation Programme (DSIRP), a structured and progressive exercise-based protocol specifically designed for individuals with atraumatic shoulder instability. Participants in this arm will perform the program three times per week, 25 minutes per session, over a total of 8 weeks. The intervention is supervised by trained p...Show More | Exercise Participants assigned to the intervention group will complete the Derby Shoulder Instability Rehabilitation Programme (DSIRP), a structured and progressive exercise-based protocol specifically designed for individuals with atraumatic shoulder instability. The program integrates strengthening exercises, proprioceptive and neuromuscular control training, plyometric drills, and speed-oriented stabilization tasks. Progre...Show More |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Pain intensity | Pain intensity will be assessed using the Numeric Pain Rating Scale (NPRS), an 11-point numerical rating scale ranging from 0 ("no pain") to 10 ("worst imaginable pain"). The NPRS has demonstrated adequate test-retest reliability, with intraclass correlation coefficients (ICC) ranging from 0.63 to 0.92, and strong internal consistency, with Cronbach's alpha values between 0.84 and 0.98, as previously reported in studies evaluating its psychometric properties (Stratford \& Spadoni, 2001; Jensen \& McFarland, 1993; Jensen et al., 1986) | From enrollment to the end of treatment at 8 weeks |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Shoulder disability | Shoulder disability will be assessed using the Spanish version of the Shoulder Pain and Disability Index (SPADI), a self-reported questionnaire designed to measure shoulder pain and functional limitations through 13 items originally developed by Williams et al. (1995). The instrument has demonstrated the ability to discriminate between patients who improve and those who worsen (Roy et al., 2009), and its Spanish cross-cultural adaptation preserves the original structure and psychometric properties, providing a reliable and valid patient-reported outcome measure suitable for both clinical practice and research (Membrilla-Mesa et al., 2015) | From enrollment to the end of treatment at 8 weeks |
External rotation strength | Isometric external rotation strength of the shoulder will be measured using the MicroFET 2 MT Digital Handheld Dynamometer (Hoggan Health Industries, West Draper, UT). Handheld dynamometry has shown good to excellent intra-examiner reliability for isometric shoulder strength assessment, with intraclass correlation coefficients ranging from 0.87 to 0.99, according to prior studies evaluating its reproducibility in clinical and research settings (McLaine et al., 2016; Holt et al., 2016) | From enrollment to the end of treatment at 8 weeks |
Hand grip strength | Hand grip strength will be measured using a Jamar handheld dynamometer (Sammons Preston Rolyan, Bolingbrook, IL), a device widely recognized for its robustness and reproducibility. This instrument has demonstrated good to excellent intra-examiner reliability for isometric grip strength outcomes, with intraclass correlation coefficients ranging from 0.85 to 0.98 in previous validation studies (Roberts et al., 2011) | From enrollment to the end of treatment at 8 weeks |
Shoulder mobility | Shoulder range of motion will be assessed for flexion, abduction, external rotation at 0°, external rotation at 90°, and internal rotation at 90° of abduction using a validated smartphone inclinometer application (Plaincode Software Solutions, Gunzenhausen, Germany). This tool has shown excellent inter-examiner reliability and validity in symptomatic individuals, with intraclass correlation coefficients greater than 0.80 for shoulder mobility measurements (Werner et al., 2014) | From enrollment to the end of treatment at 8 weeks |
Health-related quality of life | Health-related quality of life will be measured using the Short Form-12 Health Survey (SF-12), which evaluates eight dimensions of perceived physical and mental health. This questionnaire has been widely validated across diverse populations and has consistently demonstrated strong reliability and construct validity for assessing global functional health status (Ware et al., 1996) | From enrollment to the end of treatment at 8 weeks |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult
Minimum Age
18 Years
Eligible Sexes
All
- Amateur volleyball players.
- Age range: 18 to 30 years.
- Clinical diagnosis of atraumatic shoulder instability.
- Symptom duration greater than 3 months.
- Previous surgeries on the affected shoulder.
- Previous fractures of the affected shoulder.
- History of traumatic shoulder dislocation.
- Shoulder pain originating from cervical spine pathology.
- Presence of pain in the elbow, wrist, or hand.
- Clinical diagnosis of rotator cuff-related shoulder pain or frozen shoulder.
- Medical diagnosis of cardiovascular, rheumatologic, or neurological disorders.
- Pregnancy.
- Cognitive impairment.
- Concurrent physiotherapy treatment during the study period.
- Use of analgesic or anti-inflammatory medication within 24 hours prior to study assessments.
Universidad Francisco de VitoriaStudy Responsible Party
Alberto Roldán, Principal Investigator, Principal Investigator, Universidad Francisco de Vitoria
No contact data.