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

NCT07400900 | Not Yet Recruiting

• 1 other identifier: VolleyShoulder
• Study Type: interventional
• Target: 22
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Shoulder Instability

Keywords

voleyball; shoulder pain; instability; exercise; Derby Shoulder Instability Rehabilitation Programme; randomized controlled trial; overhead

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (5)

• 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

Study Arms (2)

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

Other: Exercise

Interventions

Exercise OTHER

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. Progression through the exercises is criterion-based, following predefined functional milestones to ensure appropriate challenge and individualized adaptation. The DSIRP focuses on enhancing dynamic glenohumeral stability through rotator-cuff activation, scapular control, and kinetic-chain coordination. Each session includes components targeting isometric and isotonic strengthening, closed-chain stability tasks, rhythmic stabilization, rapid-response perturbation activities, and overhead-sport-specific movement patterns relevant to volleyball athletes.

Also known as: Derby Shoulder Instability Programme

Intervention group

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad Francisco de Vitoria: lead

MeSH Terms

Conditions

Shoulder Pain; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Arthralgia; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: The study uses an interventional, parallel-group randomized controlled design to compare a standardized shoulder stabilization exercise program with a no-treatment control condition in amateur volleyball players with atraumatic shoulder instability. Participants are randomly assigned in a 1:1 ratio to one of the two study arms. The interventional group follows a structured rehabilitation protocol based on the Derby Shoulder Instability Rehabilitation Programme, conducted three times per week for eight weeks, while the control group receives no active intervention ("wait-and-see").

Study Record Dates

• First Submitted: February 3, 2026
• First Posted: February 10, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: May 4, 2026

Record last verified: 2026-02