Rue 2004.
Methods | Randomised, placebo‐controlled trial | |
Participants | Setting: US Naval Academy Size: 40 midshipmen with 58 stress fractures; data reported for 26 (14 in the treatment group and 12 in the control group) midshipmen with tibial stress fractures. Baseline characteristics: 23 men and 17 women; mean age 19 years; fractures sites were tibia, metatarsal, femur and fibula (74%, 9%, 5% and 5% respectively) Inclusion: new midshipmen sustaining stress fractures diagnosed on radiographic and scintigraphic examinations during initial training. Informed consent. Exclusion: none |
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Interventions | While not stated explicitly it is likely that all participants received the standard‐of‐care treatment that included protected weight bearing if normal walking reproduced symptoms, alternative aerobic exercise, a daily multivitamin and calcium supplementation (twice daily 500 mg). Test: daily 20‐minute LIPUS treatment (Exogen Inc, Piscataway, NJ) administered by sports medicine personnel until stress fracture had healed. Control: similar protocol with a sham unit. |
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Outcomes | Follow‐up schedule: daily treatments until fit to return to duty (work) defined as no pain on palpation, the ability to do a single leg hop on the affected side without pain and radiographic evidence of healing. Primary outcome: time to return to duty (work). Secondary outcome: adherence. |
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Notes | Although 40 participants were enrolled with a variety of injured bones, only 33 were able to comply with the protocol for a variety of reasons. Of these 33, 7 further participants were excluded from the analysis as only those with fractures of the tibia were analysed (total attrition: 14 of 40). The 26 participants had 43 tibial stress fractures ‐ time to return to duty was based on stress fracture site with the longest duration of symptoms. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "...and were randomized into one of two treatment protocols..." Comment: No description of sequence generation. |
Allocation concealment (selection bias) | Unclear risk | Quote: "...and were randomized into one of two treatment protocols..." Comment: No description of allocation concealment. |
Blinding (performance bias and detection bias) Patient‐reported measures | Low risk | Quote: "The placebo group underwent the identical protocol, except that the stimulator unit was non‐functional. This study was a double‐blind, placebo‐controlled investigation." Comment: Participants were blinded to intervention. |
Blinding (performance bias and detection bias) Objective measures | Unclear risk | Quote: "This study was a double‐blind ... investigation." Comment: Trial personnel administered the treatments and documented adherence. It is not explicit that they were also blind to the allocation although the study was 'double‐blind'. |
Incomplete outcome data (attrition bias) Patient‐reported measures | High risk | Overall attrition proportion was 14 of 40 and the loss was explicitly systematic. |
Incomplete outcome data (attrition bias) Objective measures | High risk | Overall attrition proportion was 14 of 40 and the loss was explicitly systematic. |
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 | Smoking status is not reported. |