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Shoulder motion restriction band has no effect on recurrence of shoulder dislocation
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August 2013
Shoulder motion restriction band has no effect on recurrence of shoulder dislocation
Study Type:Randomized Trial
OE Level Evidence:2
Journal Level of Evidence:N/A
Is protecting the healing ligament beneficial after immobilization in external rotation for an initial shoulder dislocation?
Am J Sports Med. 2013 May;41(5):1126-32. doi: 10.1177/0363546513480620. Epub 2013 Mar 22Did you know you're eligible to earn 0.5 CME credits for reading this report? Click Here
Synopsis
109 patients with traumatic shoulder dislocation were randomized to determine the effect of a shoulder motion restriction band on recurrence rates. Following reduction and immobilization in external rotation for 3 weeks, participants received either 6- or 3-week use of the restriction band, or no band use. Assessments were conducted for a minimum of 2 years following reduction, and no difference between groups was observed for overall recurrence of shoulder dislocation, even when patients were stratified by age.
Publication Funding Details
+
Funding:
Not Reported
Conflicts:
Royalties
Was the allocation sequence adequately generated?
Was allocation adequately concealed?
Blinding Treatment Providers: Was knowledge of the allocated interventions adequately prevented?
Blinding Outcome Assessors: Was knowledge of the allocated interventions adequately prevented?
Blinding Patients: Was knowledge of the allocated interventions adequately prevented?
Was loss to follow-up (missing outcome data) infrequent?
Are reports of the study free of suggestion of selective outcome reporting?
Were outcomes objective, patient-important and assessed in a manner to limit bias (ie. duplicate assessors, Independent assessors)?
Was the sample size sufficiently large to assure a balance of prognosis and sufficiently large number of outcome events?
Was investigator expertise/experience with both treatment and control techniques likely the same (ie.were criteria for surgeon participation/expertise provided)?
Yes = 1
Uncertain = 0.5
Not Relevant = 0
No = 0
The Reporting Criteria Assessment evaluates the transparency with which authors report the methodological and trial characteristics of the trial within the publication. The assessment is divided into five categories which are presented below.
3/4
Randomization
3/4
Outcome Measurements
3/4
Inclusion / Exclusion
4/4
Therapy Description
4/4
Statistics
Detsky AS, Naylor CD, O'Rourke K, McGeer AJ, L'Abbé KA. J Clin Epidemiol. 1992;45:255-65
The Fragility Index is a tool that aids in the interpretation of significant findings, providing a measure of strength for a result. The Fragility Index represents the number of consecutive events that need to be added to a dichotomous outcome to make the finding no longer significant. A small number represents a weaker finding and a large number represents a stronger finding.
Why was this study needed now?
Traumatic shoulder dislocations, which boast one of the highest recurrence rates, are almost invariably associated with a Bankart lesion. Immobilization in 10 degrees external rotation for 3 weeks following the injury has been suggested as an appropriate protocol for healing of the lesion, however the true length of time required for healing is still unknown. Furthermore, it is imperative that the inferior glenohumeral ligament-labrum (IGHL) complex, in which healing is still ongoing following 3 weeks of immobilization, not be stretched. Maximum tension on the IGHL occurs with the arm at 90 degrees abduction and maximum external rotation, which may be protected by the use of a motion restriction band.
What was the principal research question?
Following 3-week immobilization at 10-15 degrees external rotation after traumatic shoulder dislocation, what was the effect of 6- or 3-week use of a shoulder motion restriction band compared to no band use on recurrent shoulder dislocation within 2 years?
Study Characteristics
-
Population:
109 patients with an initial traumatic anterior dislocation of the shoulder. Patients must have been seen within 3 days of the injury, and had no associated fractures of the shoulder. All patients underwent immobilization in 10-15 degrees external rotation for 3 weeks following reduction (Shoulder Brace ER, Alcare Co.).
Intervention:
6-week group: Patients were allocated to wear the shoulder motion restriction band for 6 weeks after immobilization. Bands were adjusted to limit shoulder elevation to 60 degrees, so patient could not elevate the arm up to 90 degrees abduction and external rotation. Bands were to be worn full time except for during sleep (Mean age: 29; n=36)
3-week group: Patients were allocated to wear the shoulder motion restriction band for 3 weeks after immobilization. Bands were adjusted as described above, and were to be worn full time except for during sleep (Mean age: 30; n=37)
Comparison:
0-week group: Patients did not receive the shoulder motion restriction band (Mean age: 31; n=36)
Outcomes:
Primary outcome was recurrence of dislocation, with the nature of the dislocation also inquired about. Patients were also asked if they had returned to their preinjury sports. Compliance to immobilization and band usage was also assessed.
Methods:
RCT, Multicentre, Prospective
Time:
Follow-up conducted at 6, 12, and 24 months
What were the important findings?
- Recurrent dislocation occurred in 8/29 0-week patients (28%), 10/30 3-week patients (33%), and 10/31 6-week patients (32%) (P=0.88). 20 of the shoulders with recurrent dislocation (71%) were due to sports injuries.
- In the subgroup analysis of patients 30 years of age or younger, recurrence rates were 7/15 in the 0-week group (47%), 9/21 in the 3-week group (43%), and 8/24 in the 6-week group (33%) (P=0.67).
- In the subgroup analysis of patients over the age of 30, recurrence rates were 1/14 in the 0-week group (7%), 1/9 in the 3-week group (11%), and 2/7 in the 6-week group (29%) (P=0.43).
- Rates of return to sports was 18/21 0-week patients (86%), 16/22 3-week patients (73%), and 21/24 6-week patients (88%) (P=0.39). Return to preinjury level was 13/21 in the 0-week group (62%), 12/22 in the 3-week group (55%), 14/24 in the 6-week group (58%) (P=0.89).
- Return to contact sports was 1/2 in the 0-week group (50%), 4/7 in the 3-week group (57%), and 2/2 in the 6-week group (100%) (P=0.35). Return to noncontact sports was 9/16 in the 0-week group (56%), 6/13 in the 3-week group (46%), and 12/22 in the 6-week group (55%) (P=0.85).
- There was no significant difference between groups in rates of compliance to immobilizer use (P=0.11), restriction band use (P=0.28), or both (P=0.54).
What should I remember most?
There was no difference in recurrence rates of shoulder dislocation observed with the use of a shoulder motion restriction band (for 3 and 6 weeks) compared to no use after 3 weeks of immobilization in external rotation following primary traumatic shoulder dislocation.
How will this affect the care of my patients?
These results do not suggest there is an advantageous effect of shoulder motion restriction bands with respect to recurrence of dislocation. Further investigation may consider the effect of restriction band use on clinical outcome and shoulder range of motion.
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