Strauss 1999.
| Methods | Randomised controlled trial | |
| Participants | Setting: USA hospital. Size: 20 participants, 20 fractures; 10 fractures in each group. Baseline characteristics: not reported. Inclusion: patients with a fracture of the fifth metatarsal (zone II). Exclusion: not stated. |
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| Interventions | All fractures were initially treated with short leg cast and weightbearing as tolerated for a mean of 10 days. All casts were converted to a hinged ankle foot orthosis and patients continued with weightbearing until fracture union. Test: participants were given LIPUS therapy for 20 minutes twice each day. Control: participants were given no additional placebo treatment. |
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| Outcomes | Follow‐up schedule: not reported Primary: time to clinical and radiographic union Secondary: proportion of union within 20 weeks |
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| Notes | Inadequate data were presented to include the primary outcome in the analysis in this review. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Quote: "...were studied in a prospective randomized setting. The twenty fractures were randomly divided..." Comment: Method of randomisation is unclear. |
| Allocation concealment (selection bias) | Unclear risk | Quote: "...were studied in a prospective randomized setting. The twenty fractures were randomly divided..." Comment: Method of randomisation is unclear. |
| Blinding (performance bias and detection bias) Objective measures | High risk | Quote: "...Group B (control or no ultrasound treatment)." Comment: Control group received no sham LIPUS machine. |
| Incomplete outcome data (attrition bias) Objective measures | Low risk | All participants were followed up to the final time point of the study. |
| Selective reporting (reporting bias) | Unclear risk | No protocol available. |
| Other bias | High risk | This study was only reported as a poster abstract. The detail contained within this report is minimal and evaluation of the risk of bias is extremely limited |
| Selection bias (imbalance in baseline characteristics) | Unclear risk | Baseline characteristics were not reported. |