Apprehension-based Training Compared with Standard Physical Therapy for Military Personnel Following Anterior Shoulder Dislocation - a Randomized Clinical Trial

Not Applicable

Recruiting

• Conditions: Anterior Shoulder Dislocation

• Registration Number: NCT06752551
• Lead Sponsor: Alon Rabin

Brief Summary

The goal of this clinical trial is to determine if a new rehabilitation protocol (apprehension-based training), leads to better recovery after shoulder dislocation among military personnel.

Participants will be randomly allocated to apprehension-based training or standard physical therapy. In apprehension-based training participants will train to control their shoulder under progressively more unstable conditions. Standard physical therapy will be provided based on the clinical judgment of the treating physical therapist The primary hypothesis is that participants undergoing apprehension-based training will experience a more complete recovery of function, better shoulder-related quality of life, and incur less recurrent dislocations.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-12-22
• Study First Submitted QC: 2024-12-22
• Study First Posted: 2024-12-30
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-02
• Study Start: 2025-02-05
• Last Update Posted: 2025-02-05
• Primary Completion: 2027-12-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 85

Inclusion Criteria

• Age 18-39 years
• Shoulder dislocation (primary or recurrent) documented by a medical practitioner (physician, military medic)
• Positive anterior apprehension test
• Gross shoulder muscle strength 3/5 or greater

Exclusion Criteria

• Previous shoulder fracture, tendon tear, or shoulder surgery
• Voluntary shoulder dislocation
• Functional (Stanmore polar III) shoulder instability
• Dislocation associated with a motor vehicle accident.
• Diagnosis of rheumatoid arthritis, cancer (current), fibromyalgia, psychiatric disease)
• Current pregnancy
• Inability to attend at least one physical therapy session every 2 weeks.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Return to preinjury level of function	3 months following the end of intervention	Patient's ability to resume their preinjury military and overall level of function will be assessed separately through a telephone interview 3 months after the end of their assigned intervention. This outcome will be rated dichotomously: "Yes" (have resumed my preinjury military/overall level of function), or "No" (have not been able to resume my preinjury military/overall level of function).
Western Ontario Shoulder Instability Index	Baseline to end of intervention (10 weeks) and 1-year follow-up (62 weeks).	The Western Ontario Shoulder Instability Index is a self-reported measure of shoulder instability related quality of life. This questionnaire includes 21 items regarding symptoms, activity limitations, quality of life and emotions. Each item is scored on a 100mm visual analogue scale resulting in a total score of 0 - 2100 which can be converted to a percentage with greater scores indicating greater disability.
Recurrence	One year following the end of the intervention	Recurrent events of instability, either in the form of a frank dislocation or a sensation of instability (subluxation) will be assessed through a telephone interview.
Supine moving apprehension test	Baseline to end of intervention (10 weeks)	Dynamic stability will be assessed with the supine moving apprehension test. This is a functional performance test in which the patient is asked to repeatedly move the shoulder into 135- and 180-degrees of abduction from a supine position while holding a dumbbell (2-3 kg). The number of repetitions over one minute comprises the score of the test.

Secondary Outcome Measures

Name	Time	Method
Tampa scale of kinesiophobia	Baseline, end of intervention (10 weeks), and 1-year follow-up (62 weeks)	A self-reported 17-item fear of movement and reinjury measure. Each item is scored on a 4-point Likert scale for a total score between 17-68.
Subjective shoulder value	Baseline, end of intervention (10 weeks), and 1-year follow up (62 weeks)	A patient reported single numeric assessment of shoulder function as a percent of a normal shoulder: "What is the overall percent value of your shoulder if a completely normal shoulder represents 100%?"
Anterior apprehension test	Baseline to end of intervention (10 weeks)	The sensation of apprehension will be assessed through the anterior apprehension test performed in 4 stages: 1.) shoulder abduction to 90 degrees; 2.) external rotation; 3.) horizontal abduction; 4.) Shoulder abduction beyond 90 degrees. Elicitation of apprehension (verbal, fascial expression, or muscle guarding) will be rated according to the stage at which it occurs (1-4). The test will be rated negative (5) if apprehension is not elicited at any stage.
Shoulder internal/external rotator muscle strength	Baseline and end of intervention (10 weeks)	Shoulder internal and external rotator muscle strength will be assessed using a hand-held dynamometer in a supine-lying position with the shoulder abducted 90 degrees, neutral rotation, and the elbow bent 90 degrees. The examiner will position a hand-held dynamometer over the distal anterior (internal rotator strength) or posterior (external rotator strength) aspect of the forearm and resist a maximal voluntary effort by the patient. two repetitions will be performed for each strength test with the highest value used for data analysis.
Abdominal rollout	Baseline and end of intervention (10 weeks)	From a kneeling position with the hands gripping a barbell loaded with a 5kg plate on each side, the patient will roll forward to the greatest distance possible and return to the starting position. The test will be performed in a narrow (shoulder width) and wide (2x shoulder width) hand grip. Up to 5 repetitions will be allowed to achieve maximum distance in each grip condition.
Heart rate variability	Baseline and end of intervention (10 weeks).	Heart rate variability (HRV) during apprehension provocative and non-apprehension provocative shoulder movements will be measured using a Polar H10 chest strap. Heart rate variability will serve a physiological marker for autonomic nervous system response to movement provoked stress in the context of anterior shoulder dislocation.

Trial Locations

Locations (1)

Israel Defense Forces Medical Corps; 🇮🇱 Beer Yaakov, Israel