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.