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

NCT06752551 | Recruiting

• 1 other identifier: 2388-2023
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 1

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.

Conditions

Anterior Shoulder Dislocation

Keywords

Randomized clinical trial; Anterior shoulder dislocation; Shoulder instability; Physical therapy

Outcome Measures

Primary Outcomes (4)

• Return to preinjury level of function

  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).

  3 months following the end of intervention

• Western Ontario Shoulder Instability Index

  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.

  Baseline to end of intervention (10 weeks) and 1-year follow-up (62 weeks).

• Recurrence

  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.

  One year following the end of the intervention

• Supine moving apprehension test

  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.

  Baseline to end of intervention (10 weeks)

Secondary Outcomes (6)

• Subjective shoulder value

  Baseline, end of intervention (10 weeks), and 1-year follow up (62 weeks)

• Tampa scale of kinesiophobia

  Baseline, end of intervention (10 weeks), and 1-year follow-up (62 weeks)

• Anterior apprehension test

  Baseline to end of intervention (10 weeks)

• Shoulder internal/external rotator muscle strength

  Baseline and end of intervention (10 weeks)

• Abdominal rollout

  Baseline and end of intervention (10 weeks)

Study Arms (2)

Apprehension-based training

EXPERIMENTAL

Apprehension-based training is a 3-phase exercise intervention intended to expose patients to progressively increased shoulder apprehension-provoking conditions. Patients progress from one phase to the other upon completion of the previous level of exercise

Behavioral: Apprehension-based training

Standard physical therapy

ACTIVE COMPARATOR

Standard physical therapy will be provided by a licensed physical therapist and may include exercises of different kinds, manual therapy, dry needling or electrophysiological modalities.

Behavioral: Standard physical therapy

Interventions

Apprehension-based training BEHAVIORAL

This intervention is comprised of the 3 phases: Static phase - Isometric (static) exercises performed in progressively greater shoulder apprehension ("instability") provoking conditions Dynamic phase: Isotonic (dynamic) exercises using shoulder apprehension-provoking movement patterns at a gradually increasing pace of movement. Neurocognitive phase: Dynamic phase exercises are continued at a high pace with the addition of cognitive tasks ("distractions"). The intervention is guided by a physical therapist and includes up to 8 individual (one on one) sessions. In each session the physical therapist assesses exercise performance quality and when appropriate progresses exercise intensity and/or phase. Patients are expected to perform home exercises according to their phase of the program on a daily basis in between physical therapy sessions.

Apprehension-based training

Standard physical therapy BEHAVIORAL

Standard physical will be provided based on the assessment and judgment of the physical therapist. Intervention may include active exercises for increased shoulder mobility, muscle strength and neuromuscular control. Intervention may also include manual therapies such as massage, soft-tissue and joint mobilizations, dry needling, and electrophysiological modalities. No more than 8 individual sessions with a physical therapist will be provided over the course of treatment with some form of a home exercise program in between.

Standard physical therapy

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alon Rabin: lead
• Medical Corps, Israel Defense Force: collaborator

Study Sites (1)

Israel Defense Forces Medical Corps

Be’er Ya‘aqov, 7030732, Israel

RECRUITING

Related Publications (2)

• Rabin A, Noyman L, Yaakobi N, Kazum E. Apprehension-Based Training: A Novel Treatment Concept for Anterior Shoulder Dislocation - A Case Report. Int J Sports Phys Ther. 2024 Jul 1;19(7):888-897. doi: 10.26603/001c.118928. eCollection 2024.

  PMID: 38966825 BACKGROUND

• Rabin A, Chechik O, Olds MK, Uhl TL, Kazum E, Deutsch A, Citron E, Cohen T, Dolkart O, Bibas A, Maman E. The supine moving apprehension test-Reliability and validity among healthy individuals and patients with anterior shoulder instability. Shoulder Elbow. 2024 Feb;16(1):98-105. doi: 10.1177/17585732231170197. Epub 2023 Apr 18.

  PMID: 38435037 BACKGROUND

Study Officials

• Alon Rabin, PhD, DPT

  Ariel University

  STUDY CHAIR

Central Study Contacts

Alon Rabin, PhD, DPT

CONTACT

972-52-3581550; alonra@ariel.ac.il

Netanel Hollander, MS, PT

CONTACT

972-52-9216908; netanel911@gmail.com

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: SPONSOR INVESTIGATOR
• PI Title: Principal investigator

Model Details: Randomized controlled trial: Study intervention: apprehension-based training Control intervention: standard physical therapy

Study Record Dates

• First Submitted: December 22, 2024
• First Posted: December 30, 2024
• Study Start: February 5, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: June 4, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: 1.1.2028-1.1.2029
• Access Criteria: Scholars, medical professionals as well as the general public may access outcomes measures data, intervention protocol and statistical analyses upon request from the principal investigator at the URL provided below.

Locations

IL (1)