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. 2016 Dec 15;2016(12):CD007121. doi: 10.1002/14651858.CD007121.pub4

Summary of findings 2. Summary of findings: low‐intensity pulsed ultrasound.

Low‐intensity pulsed ultrasound compared with placebo for treating fractures of the middle third of the clavicle
Patient or population: patients with fractures of the middle third of the clavicle
Settings: hospital
Intervention: low‐intensity pulsed ultrasound
Comparison: placebo
Outcomes Illustrative comparative risks* (95% CI) Relative effect
 (95% CI) No of Participants
 (studies) Quality of the evidence
 (GRADE) Comments
Assumed risk Corresponding risk
Placebo Low‐intensity pulsed ultrasound
Shoulder function See comment See comment Not estimable See comment Not measured in the trial
Pain
Visual analogue scale ‐ VAS (0 (no pain) to 10 (worst pain))
Follow‐up: in the 28‐day treatment period
Mean pain in the control group was
 3.55 points Mean pain in the intervention group was 0.04 points lower (0.61 lower to 0.53 higher) MD ‐0.04 (95% CI ‐0.61 to 0.53) 101 (1 study) ⊕⊕⊕⊝
 moderate¹  
Treatment failure ‐ Number who had surgical procedure See comment See comment RR 1.13 (0.37 to 3.47) 101 (1 study) ⊕⊕⊕⊝
 moderate¹ Only one trial assessed this comparison
Clinical healing ‐ Time to clinical fracture consolidation (days) Mean clinical healing in the control group was 27.09 days Mean clinical healing: time to clinical/radiographic fracture consolidation (days) in the intervention group was 0.32 days lower (5.85 lower to 5.21 higher) MD ‐0.32 weeks (‐5.85 to 5.21) 101 (1 study) ⊕⊕⊕⊝
 moderate¹  
Adverse events ‐ total of adverse events
(Skin irritation)
Follow‐up: during the intervention
See comment See comment RR 0.94 (0.06 to 14.65) 101 (1 study) ⊕⊕⊕⊝
 moderate¹ Only one trial assessed this comparison
Quality of life See comment See comment Not estimable See comment Not measured in the trial
Return to previous activities ‐ Resumption of work (days) Mean time to return to previous activities in the control group was
 15.05 days Mean time to return to previous activities (days) ‐ resumption of work in the intervention group was 1.95 weeks higher (2.18 lower to 6.08 higher) MD 1.95 days (‐2.18 to 6.08) 101 (1 study) ⊕⊕⊕⊝
 moderate¹  
*The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
 CI: confidence interval; MD: mean difference; RR: risk ratio; VAS: visual analogue scale.
GRADE Working Group grades of evidence
 High quality: Further research is very unlikely to change our confidence in the estimate of effect.
 Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
 Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
 Very low quality: We are very uncertain about the estimate.

¹ We downgraded the evidence one level for imprecision given the wide confidence interval and that the available data were from only one trial.