Skip to main content
OpenTrials
Completed

NCT Number: NCT02371928

A Neuromuscular Exercise Program for Patients With Anterior Shoulder Instability

This study is designed to investigate the efficacy and safety of a supervised neuromuscular exercise program versus a standard home exercise program for patients with post-traumatic symptomatic anterior shoulder instability.

Participants with at least one week of symptom duration are randomly assigned to either a 12-week structured, supervised Shoulder Instability Neuromuscular EXercise (SINEX) program versus a standard HOMe EXercise (HOMEX) program.

The H1-hypothesis is that the SINEX program results in a greater increase in quality of life and physical function than the HOMEX program at the primary endpoint at three months follow-up from baseline

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Shoulder Dislocation Behavior Disease Attributes Joint Diseases Joint Dislocations Motor Activity Musculoskeletal Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence Shoulder Injuries Wounds and Injuries

Age range

18 year–39 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Odense University Hospital, Odense, Fyn, Denmark

Loading trial locations.

About this study

A common, and very painful, injury for individuals in their second and third decades is a traumatic dislocated shoulder. This injury accounts for almost 50% of all joint dislocations registered in the emergency departments. Due to post-traumatic laxity and injuries to the surrounding shoulder tissue, one major problem is the risk of developing a chronic recurrent instable shoulder affecting patients both physically and psychologically decreasing their overall quality of life.

Biomechanically, proprioceptive changes and decreased sensorimotor control are found in patients with post-traumatic shoulder instability inhibiting the ability to control and stabilize the glenohumeral joint. In other similar musculoskeletal disorders, recent studies clearly shows positive effects of progressive neuromuscular exercise.

Finally, no studies have yet investigated the effect of a structured, physical exercise-training regime based on neuromuscular principles targeting the shoulder joint.

This trial is performed as a randomized, assessor-blinded, controlled multi-center trial with cooperation from various shoulder outpatient clinics located at different hospitals in The Region of Southern and Northern Denmark.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age between 18-39
  • Minimum one radiographic verified anterior shoulder dislocation (total dissociation of the humeral head to the glenoid)
  • Limited ability to maintain a desired level of physical activity (sports/leisure/work) due to pain and/or symptoms in the affected shoulder within the latest week.

Exclusion criteria

  • Humeral fracture and/or bony bankart (visible on conventional radiographs at the time of presentation) warranted for surgery decided by the orthopedic (no other axial or appendicular musculoskeletal injury)
  • Prior surgery in affected shoulder joint
  • >5 anterior shoulder dislocations (verified by journal or subjective evaluation)
  • Suspected competing diagnosis (e.g. rheumatoid arthritis, cancer, neurological disorders, fibromyalgia, schizophrenia, suicidal threatened, borderline personality disorder or obsessive compulsive disorder
  • Sensory and motor deficits in neck and shoulder
  • Pregnancy
  • Inadequacy in written and spoken Danish
  • Not willing or able to attend 12 weeks of supervised exercise therapy

Treatment and study plan

Neuromuscular exercise program

Other

Exercises can be individually progressed from basic to elite level.

Low load exercises are performed every day with 2 sets of 20-25 repetitions whereas high load exercises are performed three times per week with 2 sets of 8-12 repetitions.

Exercises are progressed using the following components: arm-position, load, speed, open/closed eyes, stable/unstable surfaces.

Patients have online access to instructions and video recordings of all exercises and progression levels. Patients are trained to continuously evaluate their own shoulder function and to adjust the exercise levels themselves at home.

Supervision will be given two times a week for the first two weeks and then once a week for the remaining period.

Standard home exercise program

Other

Strengthening of the rotator cuff muscles are performed with the use of elastic bands (shoulder internal and external rotation besides abduction in scapular plane) whereas mobility/strengthening exercise for the scapular muscles are performed through weight-bearing positions and movements of the upper extremity.

All exercises are performed three times a week with 2 sets of 10 repetitions.

Primary outcomes

  1. Change in Western Ontario Shoulder Instability Index (WOSI)

    Time frame: Primary: 3 months. Other: 12, 24 months

    The patient reported outcome, WOSI, consists of four domains covering "Physical Symptoms", "Sport/Recreation/Work", "Lifestyle" and "Emotions" with 21-item questionnaires in all. Each item is scored using a horizontal visual scale ranging from 0 to 100 mm (0-2100, with 0 as the level of no trouble).

Secondary outcomes

  1. Change in Euro Qol 5D Index (EQ-5D)

    Time frame: 3,12, 24 months

    Quality of life questionnaire

  2. Change in Tampa Scale of Kinesiophobia

    Time frame: 3,12, 24 months

    Fear of movement and re-injury questionnaire

  3. Change in the four sub-scales (domains) of WOSI

    Time frame: 3,12, 24 months

    Questionnaire

  4. Change in Patient Specific Functioning Scale

    Time frame: 3 months

    Questionnaire

  5. Global Perceived Effect

    Time frame: 3 months

    Questionnaire

  6. Change in Constant-Murley Shoulder Score

    Time frame: 3 months

    100-point scoring system with self-reported and objective measurements included.

  7. Number of changes in positive clinical tests for anterior shoulder instability

    Time frame: 3 months

    Provocative clinical tests for anterior shoulder instability will be used to measure the number of positive and negative tests (Apprehension, relocation, surprise test)

  8. Change in shoulder joint position sense

    Time frame: 3 months

    Re-positioning test of the affected shoulder in abduction and flexion with the use of laser pointer measurements.

  9. Number of participants with adverse events

    Time frame: 3 months

    Open-probe questioning at 3 months follow-up besides any adverse events during the 12-week exercise program registered by the physiotherapists supervising the patients.

Other outcomes

  1. Baseline demographics and other relevant information (age, sex, symptom intensity and duration, number of shoulder dislocations, medical use, prior physical treatment, Time to return to sport or work, )

    Time frame: Baseline and 3,12, 24 months

    Questionnaire

  2. Change in mechanical allodynia (exploratory)

    Time frame: 3 months

    Pain pressure threshold measured in the affected shoulder using a handheld algometer (Algometer Type II) at four sites (m. pec. major, the deltoid m., m. trapezius superior and m. levator scapula) and one site at opposite m. tibialis anterior.

  3. Change in number of sites with pain (exploratory)

    Time frame: 3 months

    Self-reported pain registration within the previous 24 hours shaded on a region-divided body chart.

  4. Change in pain scores

    Time frame: 3, 12, 24 months

    Using 100 mm visual analogue scale (VAS) with anchor points "no pain" and "worst imaginable pain" in various situations.

  5. Change in maximum isometric muscle strength

    Time frame: 3 months

    Measured bilaterally in 90 degrees of abduction in the scapular plane using an Isoforce dynamometer.

Sponsors and collaborators

Lead sponsor

University of Southern Denmark

Other

Collaborators

  • Aalborg University Hospital
  • Region of Southern Denmark
  • The Danish Rheumatism Association

Registry information

Official study title

A Neuromuscular Exercise Program for Patients With Anterior Shoulder Instability: A Randomized Controlled Trial

Acronym: SINEX

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Feb 26, 2015
Registry last updated
Mar 9, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.