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Clinical Trials/NCT07400900
NCT07400900
Not yet recruiting
Not Applicable

Effectiveness of a Standardised Stabilisation Exercise Protocol in Volleyball Players With Non-traumatic Shoulder Instability

Universidad Francisco de Vitoria0 sites22 target enrollmentStarted: March 1, 2026Last updated:
InterventionsExercise

Overview

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Universidad Francisco de Vitoria
Enrollment
22
Primary Endpoint
Pain intensity

Overview

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 limitations, sleep disturbances, and high socio-economic costs. Atraumatic glenohumeral instability is particularly common among athletes performing overhead movements, such as volleyball players, who are repeatedly exposed to high-velocity external and internal rotation actions during serves and spikes.

The Derby Shoulder Instability Rehabilitation Programme (DSIRP) is a structured, reproducible protocol integrating strengthening, proprioceptive, neuromuscular control, plyometric, and speed-oriented exercises. Although widely used in clinical practice, evidence supporting its superiority over the natural progression of the condition remains limited. More than 80% of physiotherapists in the United Kingdom do not use specific standardized protocols for atraumatic shoulder instability, highlighting the need for high-quality clinical trials that evaluate structured rehabilitation approaches.

This study will recruit amateur volleyball players aged 20 to 30 years with a clinical diagnosis of atraumatic shoulder instability lasting more than 3 months. Participants will be randomized (1:1) into two parallel groups: an experimental group performing the DSIRP for 8 weeks (three 25-minute sessions per week), and a control group following a "wait-and-see" approach. Outcome measures will be assessed at baseline, 1 month, and 2 months (post-intervention). The primary outcomes include pain intensity measured with the Numeric Pain Rating Scale and shoulder disability measured with the Spanish version of the Shoulder Pain and Disability Index. Secondary outcomes include external rotation strength, grip strength, shoulder range of motion, and health-related quality of life assessed with the SF-12 questionnaire. All measurements use validated instruments with high reliability for clinical and research settings.

Statistical analysis will follow an intention-to-treat approach using mixed-model repeated-measures ANOVA or non-parametric alternatives when appropriate. Effect sizes and Bonferroni correction for multiple comparisons will be applied. An independent biostatistician blinded to allocation will conduct the analysis. The study follows CONSORT and TIDieR guidelines for reporting and intervention description.

This trial seeks to determine whether a structured, progressive stabilization protocol offers clinically meaningful improvements in pain, disability, strength, mobility, and quality of life compared with no intervention in young volleyball players with atraumatic shoulder instability. Results may support the implementation of standardized rehabilitation strategies in physiotherapy practice for this condition.

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 lead to recurrent symptoms of pain, weakness, and functional limitation, often persisting for extended periods and interfering with sports performance and daily activities.

Although physiotherapy is widely recognized as a first-line approach for managing atraumatic shoulder instability, clinical practice frequently lacks standardized and reproducible rehabilitation protocols. Existing programs vary significantly in content, dosage, and progression criteria, limiting consistency across clinicians and settings. The Derby Shoulder Instability Rehabilitation Programme (DSIRP) is one of the few structured intervention models specifically designed for this condition. It integrates strengthening, proprioception, plyometric exercises, and motor control tasks, with progression based on clearly defined functional milestones. However, despite its clinical use, robust comparative evidence supporting its effectiveness remains limited.

This randomized controlled trial aims to evaluate the clinical impact of an eight-week DSIRP-based intervention compared with no active treatment in amateur volleyball players aged 20 to 30 years with at least three months of atraumatic shoulder instability. The study follows CONSORT and TIDieR recommendations to ensure transparent reporting and comprehensive intervention description. Participants are randomly allocated in a 1:1 ratio to either the experimental group, which performs the structured exercise program three times per week, or the control group, which receives no intervention ("wait-and-see"). The analytical team remains blinded to group assignment.

The intervention is designed to address multiple dimensions of shoulder stability, including rotator-cuff strength, scapular control, reactive stability, and proprioceptive acuity. It progresses through phases that incorporate isometric and isotonic strengthening, closed-chain stability tasks, rhythmic stabilization, plyometric drills, and functional movement patterns relevant to overhead athletes. Session duration and frequency are standardized, but progression criteria ensure individualized advancement according to each participant's ability to meet predefined performance targets.

Outcome assessments are conducted at baseline, one month, and after the completion of the eight-week intervention. Measures span several domains relevant to shoulder instability, including pain intensity, self-reported disability, shoulder mobility, isometric strength, and overall health-related quality of life. All clinical instruments used in the study have demonstrated strong reliability and validity in previous research. The measurement protocol ensures standardized positioning and examiner consistency to reduce variability.

The statistical analysis incorporates repeated-measures models to evaluate changes over time and between groups. Parametric or non-parametric methods are selected based on data distribution, and effect sizes are calculated to quantify the magnitude of observed changes. A blinded biostatistician performs all analyses to minimize bias.

This study is designed to generate high-quality evidence on the usefulness of a structured, pathology-specific rehabilitation program for atraumatic shoulder instability in young overhead athletes. By comparing the DSIRP-based intervention with a no-treatment control condition, the trial aims to clarify whether a well-defined and reproducible exercise protocol leads to meaningful improvements in pain, function, strength, and mobility. Findings may inform clinical practice, support the adoption of standardized rehabilitation pathways, and contribute to reducing the variability that currently characterizes conservative management of this condition.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 30 Years (Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Amateur volleyball players.
  • Age range: 18 to 30 years.
  • Clinical diagnosis of atraumatic shoulder instability.
  • Symptom duration greater than 3 months.

Exclusion Criteria

  • 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.

Arms & Interventions

Control

No Intervention

Wait and see during 8 weeks

Intervention group

Experimental

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 physiotherapists, although progression criteria remain standardized to ensure reproducibility. No adjunct treatments (manual therapy, modalities, taping, etc.) are permitted during the intervention period. This arm aims to improve pain, functional capacity, proprioceptive control, shoulder mobility, and strength in young volleyball players with atraumatic instability, following the dosage and progression described in Bateman et al. (2015) and aligned with the intervention structure detailed in the study protocol

Intervention: Exercise (Other)

Outcomes

Primary Outcomes

Pain intensity

Time Frame: From enrollment to the end of treatment at 8 weeks

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)

Secondary Outcomes

  • Shoulder disability(From enrollment to the end of treatment at 8 weeks)
  • External rotation strength(From enrollment to the end of treatment at 8 weeks)
  • Hand grip strength(From enrollment to the end of treatment at 8 weeks)
  • Shoulder mobility(From enrollment to the end of treatment at 8 weeks)
  • Health-related quality of life(From enrollment to the end of treatment at 8 weeks)

Investigators

Sponsor
Universidad Francisco de Vitoria
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Alberto Roldán

Principal Investigator

Universidad Francisco de Vitoria

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