A Neuromuscular Exercise Program for Patients With Anterior Shoulder Instability

Musculoskeletal Diseases Clinical Trial

— SINEX  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02371928
• Other study ID #: S-20140093
• Status: Completed
• Phase: N/A
• First received: February 9, 2015
• Last updated: March 8, 2018
• Start date: February 2015
• Est. completion date: June 2017

Study information

• Verified date: March 2018
• Source: University of Southern Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: June 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 39 Years

Eligibility

Inclusion Criteria:

1. Age between 18-39

2. Minimum one radiographic verified anterior shoulder dislocation (total dissociation of the humeral head to the glenoid)

3. 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:

1. 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)

2. Prior surgery in affected shoulder joint

3. >5 anterior shoulder dislocations (verified by journal or subjective evaluation)

4. Suspected competing diagnosis (e.g. rheumatoid arthritis, cancer, neurological disorders, fibromyalgia, schizophrenia, suicidal threatened, borderline personality disorder or obsessive compulsive disorder

5. Sensory and motor deficits in neck and shoulder

6. Pregnancy

7. Inadequacy in written and spoken Danish

8. Not willing or able to attend 12 weeks of supervised exercise therapy

Related Conditions & MeSH terms

• Musculoskeletal Diseases
• Shoulder Dislocation

Intervention

Other:
• Neuromuscular exercise program
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
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.

Locations

Country	Name	City	State
Denmark	Aalborg University Hospital	Aalborg	Jutland
Denmark	Hospital of Southwest Denmark	Esbjerg	Jutland
Denmark	Himmerland Hospital	Farsø	Jutland
Denmark	Odense University Hospital	Odense	Fyn

Sponsors (4)

Lead Sponsor	Collaborator
University of Southern Denmark	Aalborg Universitetshospital, Region of Southern Denmark, The Danish Rheumatism Association

Country where clinical trial is conducted

Denmark, 

References & Publications (4)

Gibson K, Growse A, Korda L, Wray E, MacDermid JC. The effectiveness of rehabilitation for nonoperative management of shoulder instability: a systematic review. J Hand Ther. 2004 Apr-Jun;17(2):229-42. Review. — View Citation

Handoll HH, Hanchard NC, Goodchild L, Feary J. Conservative management following closed reduction of traumatic anterior dislocation of the shoulder. Cochrane Database Syst Rev. 2006 Jan 25;(1):CD004962. Review. Update in: Cochrane Database Syst Rev. 2014;4:CD004962. — View Citation

Robinson CM, Seah M, Akhtar MA. The epidemiology, risk of recurrence, and functional outcome after an acute traumatic posterior dislocation of the shoulder. J Bone Joint Surg Am. 2011 Sep 7;93(17):1605-13. doi: 10.2106/JBJS.J.00973. — View Citation

Zech A, Hübscher M, Vogt L, Banzer W, Hänsel F, Pfeifer K. Neuromuscular training for rehabilitation of sports injuries: a systematic review. Med Sci Sports Exerc. 2009 Oct;41(10):1831-41. doi: 10.1249/MSS.0b013e3181a3cf0d. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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, )	Questionnaire	Baseline and 3,12, 24 months
Other	Change in mechanical allodynia (exploratory)	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 months
Other	Change in number of sites with pain (exploratory)	Self-reported pain registration within the previous 24 hours shaded on a region-divided body chart.	3 months
Other	Change in pain scores	Using 100 mm visual analogue scale (VAS) with anchor points "no pain" and "worst imaginable pain" in various situations.	3, 12, 24 months
Other	Change in maximum isometric muscle strength	Measured bilaterally in 90 degrees of abduction in the scapular plane using an Isoforce dynamometer.	3 months
Primary	Change in Western Ontario Shoulder Instability Index (WOSI)	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).	Primary: 3 months. Other: 12, 24 months
Secondary	Change in Euro Qol 5D Index (EQ-5D)	Quality of life questionnaire	3,12, 24 months
Secondary	Change in Tampa Scale of Kinesiophobia	Fear of movement and re-injury questionnaire	3,12, 24 months
Secondary	Change in the four sub-scales (domains) of WOSI	Questionnaire	3,12, 24 months
Secondary	Change in Patient Specific Functioning Scale	Questionnaire	3 months
Secondary	Global Perceived Effect	Questionnaire	3 months
Secondary	Change in Constant-Murley Shoulder Score	100-point scoring system with self-reported and objective measurements included.	3 months
Secondary	Number of changes in positive clinical tests for anterior shoulder instability	Provocative clinical tests for anterior shoulder instability will be used to measure the number of positive and negative tests (Apprehension, relocation, surprise test)	3 months
Secondary	Change in shoulder joint position sense	Re-positioning test of the affected shoulder in abduction and flexion with the use of laser pointer measurements.	3 months
Secondary	Number of participants with adverse events	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.	3 months