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Randomized Controlled Trial
. 2016 Nov 21;6(11):e011048.
doi: 10.1136/bmjopen-2016-011048.

Ultrasound imaging to tailor the treatment of acute shoulder pain: a randomised controlled trial in general practice

Affiliations
Randomized Controlled Trial

Ultrasound imaging to tailor the treatment of acute shoulder pain: a randomised controlled trial in general practice

Ramon P G Ottenheijm et al. BMJ Open. .

Abstract

Objective: To determine the clinical effectiveness of ultrasound tailored treatment in patients with acute subacromial disorders.

Design: Pragmatic randomised controlled trial.

Setting: Dutch general practice.

Participants: Patients aged 18-65 years with acute (duration <3 months) unilateral shoulder pain and no previous treatment, in whom the general practitioner suspected a subacromial disorder was enrolled.

Interventions: All patients underwent ultrasound imaging of the affected shoulder. Patients who were still symptomatic after a qualification period of 2 weeks with standard treatment were randomised to treatment tailored to ultrasound diagnosis (disclosure of the ultrasound diagnosis) or usual care (non-disclosure of the ultrasound diagnosis).

Primary outcome measure: Patient-perceived recovery using the Global Perceived Effect questionnaire at 1 year.

Results: 129 patients were included. 18 patients recovered during the 2-week qualification period, resulting in 111 randomised patients; 56 were allocated to ultrasound tailored treatment and 55 to usual care. After 1 year, no statistically significant differences in recovery were found between the ultrasound tailored treatment group (72.5% (37/51)) and the usual care group (60% (30/50), OR 2.24 (95% CI 0.72 to 6.89; p=0.16)). Also, healthcare use was similar.

Conclusions: This study has shown no clinically significant difference in the primary outcome measure between the ultrasound tailored treatment and usual care groups. Furthermore, there was no overall difference in healthcare resources used between groups. Although no formal cost data are included, one can only assume that the ultrasound examinations are additional costs for the intervention group, which cannot be justified in routine practice based on this trial. Based on this study, no change in current pragmatic guidelines to incorporate early ultrasound imaging can be recommended.

Trial registration number: NTR2403; Results.

Keywords: Diagnosis; General practice; Treatment; Ultrasound imaging.

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Conflict of interest statement

Conflicts of Interest: None declared.

Figures

Figure 1
Figure 1
Flow chart of the study. GP, general practitioner.
Figure 2
Figure 2
Flow of patients through the study. GP, general practitioner.

References

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