Yadav 2008.
| Methods | Randomised, placebo‐controlled trial | |
| Participants | Setting: Indian military recruits in training. Size: 67 cases with stress fracture; with 39 in the treatment group and 28 in the control group. Baseline characteristics: age not reported, gender data not reported. Inclusion: history and examination consistent with a diagnosis of stress fracture. Exclusion: none. |
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| Interventions | All participants were managed non‐operatively and prescribed paracetamol and ice‐packs. Test: treated with 10 min/day using a ultrasound probe emitting a 3 MHz, 1 W/cm² ultrasound signal pulsed with a duty cycle of 50%. Control: similar treatment with a sham unit which was identical to the test unit. |
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| Outcomes | Time to return to training. No radiological outcome measures assessed. | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "...were randomly assigned ... by chit method." |
| Allocation concealment (selection bias) | Unclear risk | Quote: "...were randomly assigned ... by chit method." Comment: It is not clear whether this was done on or off site and who had access to the results. |
| Blinding (performance bias and detection bias) Patient‐reported measures | Low risk | Quotes: "... nonfunctioning unit identical in appearance." "... patients ... study's researchers were blinded..." |
| Blinding (performance bias and detection bias) Objective measures | Low risk | Quotes: "... nonfunctioning unit identical in appearance." "... patients ... study's researchers were blinded..." |
| Incomplete outcome data (attrition bias) Patient‐reported measures | Low risk | There were no missing data. |
| Incomplete outcome data (attrition bias) Objective measures | Low risk | There were no missing data. |
| Selective reporting (reporting bias) | Unclear risk | No protocol available. |
| Other bias | Low risk | No additional biases identified |
| Selection bias (imbalance in baseline characteristics) | Unclear risk | Quote: "... matched in terms of age, height, demographics, and delay from symptom onset to diagnosis." Comment: Sex and smoking status not reported. |
CT = computed tomography LIPUS = low‐intensity pulsed ultrasound NSAID = non‐steroidal anti‐inflammatory drug VAS = visual analogue scale