A Neuromuscular Exercise Program for Patients With Anterior Shoulder Instability

NCT02371928 | Completed

• 1 other identifier: S-20140093
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 4

Brief 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

Conditions

Shoulder Dislocation; Musculoskeletal Diseases

Keywords

Shoulder; Instability; Neuromuscular; Physiotherapy; Exercise; Dislocation; Recurrence

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Change in Euro Qol 5D Index (EQ-5D)

  3,12, 24 months

• Change in Tampa Scale of Kinesiophobia

  3,12, 24 months

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

  3,12, 24 months

• Change in Patient Specific Functioning Scale

  3 months

• Global Perceived Effect

  3 months

Other Outcomes (5)

• 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, )

  Baseline and 3,12, 24 months

• Change in mechanical allodynia (exploratory)

  3 months

• Change in number of sites with pain (exploratory)

  3 months

Study Arms (2)

Neuromuscular exercise program

ACTIVE COMPARATOR

A 12-week physiotherapeutic, supervised exercise program with focus on neuromuscular shoulder control besides incorporation of kinetic chain exercises. The exercise program contains the following focal points: Scapula and glenohumeral setting/control, dynamic shoulder stability, muscle co-contractions (weight-bearing upper extremity exercises) and proprioceptive training.

Other: Neuromuscular exercise program

Standard home exercise program

ACTIVE COMPARATOR

One physiotherapeutic-supervised instruction in 12 weeks of active exercises for the rotator cuff and scapular muscles. Information about the shoulder injury and how to avoid pain provoking movements besides future implications is given. Also, participants receives one phone call after six weeks of training from a physiotherapist to ensure good compliance and answer any questions that the patient may have.

Other: Standard home exercise program

Interventions

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.

Neuromuscular exercise program

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.

Standard home exercise program

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (4)

Odense University Hospital

Odense, Fyn, 5000, Denmark

Location

Aalborg University Hospital

Aalborg, Jutland, 9000, Denmark

Location

Hospital of Southwest Denmark

Esbjerg, Jutland, 6700, Denmark

Location

Himmerland Hospital

Farsø, Jutland, 9640, Denmark

Location

Related Publications (6)

• 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. doi: 10.1197/j.jht.2004.02.010.

  PMID: 15162108 BACKGROUND

• 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. doi: 10.1002/14651858.CD004962.pub2.

  PMID: 16437506 BACKGROUND

• Zech A, Hubscher M, Vogt L, Banzer W, Hansel 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.

  PMID: 19727032 BACKGROUND

• 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.

  PMID: 21915575 BACKGROUND

• Eshoj HR, Rasmussen S, Frich LH, Hvass I, Christensen R, Boyle E, Jensen SL, Sondergaard J, Sogaard K, Juul-Kristensen B. Neuromuscular Exercises Improve Shoulder Function More Than Standard Care Exercises in Patients With a Traumatic Anterior Shoulder Dislocation: A Randomized Controlled Trial. Orthop J Sports Med. 2020 Jan 30;8(1):2325967119896102. doi: 10.1177/2325967119896102. eCollection 2020 Jan.

  PMID: 32064291 DERIVED

• Eshoj H, Rasmussen S, Frich LH, Hvass I, Christensen R, Jensen SL, Sondergaard J, Sogaard K, Juul-Kristensen B. A neuromuscular exercise programme versus standard care for patients with traumatic anterior shoulder instability: study protocol for a randomised controlled trial (the SINEX study). Trials. 2017 Feb 28;18(1):90. doi: 10.1186/s13063-017-1830-x.

  PMID: 28245853 DERIVED

MeSH Terms

Conditions

Shoulder Dislocation; Musculoskeletal Diseases; Motor Activity; Joint Dislocations; Recurrence

Condition Hierarchy (Ancestors)

Joint Diseases; Wounds and Injuries; Shoulder Injuries; Behavior; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Henrik Eshoj, PhD-student

  Research Unit for Musculoskeletal Function and Physiotherapy, Institute of Sports Science and Clinical Biomechanics, University of Southern Denmark

  PRINCIPAL INVESTIGATOR

• Birgit Juul-Kristensen, Ass. Prof

  Research Unit for Musculoskeletal Function and Physiotherapy, Institute of Sports Science and Clinical Biomechanics, University of Southern Denmark

  STUDY CHAIR

• Karen Søgaard, Prof.

  Research Unit for Physical Activity and Health in Working Life, Institute of Sports Science and Clinical Biomechanics, University of Southern Denmark

  STUDY CHAIR

• Lars H Frich, MD

  Shoulder sector, Orthopaedic Department, Odense University Hospital, Denmark

  STUDY CHAIR

• Steen L Jensen, MD

  Shoulder sector, Orthopedic Department, Aalborg University Hospital, Farsø Hospital, Denmark

  STUDY CHAIR

• Sten Rasmussen, MD

  Department of Clinical Medicine, Aalborg University, Aalborg, Denmark

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Msc, PhD. stud

Study Record Dates

• First Submitted: February 9, 2015
• First Posted: February 26, 2015
• Study Start: February 1, 2015
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: March 9, 2018

Record last verified: 2018-03

Locations

DK (4)