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| Is protecting the healing ligament beneficial after immobilization in external rotation for an initial shoulder dislocation? |
| Itoi E, Hatakeyama Y, Itoigawa Y, Omi R, Shinozaki N, Yamamoto N, Sano H |
| The American Journal of Sports Medicine 2013 May;41(5):1126-1132 |
| clinical trial |
| 3/10 [Eligibility criteria: No; Random allocation: Yes; Concealed allocation: No; Baseline comparability: No; Blind subjects: No; Blind therapists: No; Blind assessors: No; Adequate follow-up: No; Intention-to-treat analysis: Yes; Between-group comparisons: Yes; Point estimates and variability: No. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed* |
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BACKGROUND: Immobilization in external rotation is one of the treatment options for an initial dislocation of the shoulder. However, it remains unclear how long it takes for a Bankart lesion to heal. HYPOTHESIS: Protection of a healing Bankart lesion from stretching would promote the healing process and decrease the recurrence rate after an initial dislocation of the shoulder. STUDY DESIGN: Randomized controlled trial; level of evidence, 2. METHODS: This was a multicenter, prospective randomized study. Between January 2005 and August 2009, 109 patients (71 male and 38 female; mean age 30 years) with an initial traumatic dislocation of the shoulder were enrolled. After 3 weeks of immobilization in external rotation, a shoulder motion restriction band designed to avoid stretching the anteroinferior shoulder capsule was used for 0 weeks (36 patients), 3 weeks (37 patients), or 6 weeks (36 patients). After using the band, patients were allowed to use their shoulders freely, but they were advised to avoid vigorous sport activities for at least 3 months after the injury. Any recurrent dislocation and return to sports were assessed at 2-year follow-up. RESULTS: Of 109 patients, 90 were followed up for 2 years. The compliance rates were 60% to 72% among the groups (p = 0.54). The recurrence rate of dislocation was 28% in the 0-week group, 33% in the 3-week group, and 32% in the 6-week group (p = 0.88) according to the intention-to-treat analysis, and they were a respective 24%, 28%, and 27% according to the per-protocol analysis (p = 0.95). Based on the sport activity level, the recurrence rates for patients involved in contact sports (7/15, 47%) and those involved in noncontact sports (19/51, 37%) were significantly higher than for those not involved in sport activities (2/24, 8.3%) (p = 0.0076). Among the 3 groups, there were no significant differences in the recurrence rates. There was no significant difference in the rate of return to sports (p = 0.39). CONCLUSION: No difference in the recurrence rate was seen with the use of a shoulder motion restriction band after 3 weeks of immobilization in external rotation after an initial dislocation of the shoulder.
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