BACKGROUND: Several randomised trials have been published on the effect of low-intensity pulsed ultrasound (LIPUS) on fracture healing in both distal radius and tibia fractures. Most studies showed a positive effect on time to clinical and radiological healing. We hypothesised that LIPUS has a beneficial effect on the healing of fresh clavicle fractures as well and studied its effect in non-operatively treated shaft fractures. METHODS: We conducted a randomised double blind, placebo-controlled multi-centre trial in 101 adult patients with a non-operatively treated fresh clavicle shaft fracture. Of these patients, 49 used a placebotransducer and 52 patients had an active transducer with ultrasound stimulation (Exogen 2000). Data were analysed on intention to treat basis. Baseline parameters of both groups were not significantly different. RESULTS: There were no differences in time to subjective clinical fracture healing, resumption of daily activities, sports or professional work, Visual Analogue pain Scores (VAS) and use of pain medication. CONCLUSION: Our findings did not confirm that LIPUS accelerates clinical healing time of fresh clavicle shaft fractures. LEVEL OF EVIDENCE: Level 1 evidence that low-intensity pulsed ultrasound does not accelerate clinical fracture healing in non-operatively treated fresh midshaft clavicle fractures.
RCT Entities:
BACKGROUND: Several randomised trials have been published on the effect of low-intensity pulsed ultrasound (LIPUS) on fracture healing in both distal radius and tibia fractures. Most studies showed a positive effect on time to clinical and radiological healing. We hypothesised that LIPUS has a beneficial effect on the healing of fresh clavicle fractures as well and studied its effect in non-operatively treated shaft fractures. METHODS: We conducted a randomised double blind, placebo-controlled multi-centre trial in 101 adult patients with a non-operatively treated fresh clavicle shaft fracture. Of these patients, 49 used a placebo transducer and 52 patients had an active transducer with ultrasound stimulation (Exogen 2000). Data were analysed on intention to treat basis. Baseline parameters of both groups were not significantly different. RESULTS: There were no differences in time to subjective clinical fracture healing, resumption of daily activities, sports or professional work, Visual Analogue pain Scores (VAS) and use of pain medication. CONCLUSION: Our findings did not confirm that LIPUS accelerates clinical healing time of fresh clavicle shaft fractures. LEVEL OF EVIDENCE: Level 1 evidence that low-intensity pulsed ultrasound does not accelerate clinical fracture healing in non-operatively treated fresh midshaft clavicle fractures.
Authors: Stefan Schandelmaier; Alka Kaushal; Lyubov Lytvyn; Diane Heels-Ansdell; Reed A C Siemieniuk; Thomas Agoritsas; Gordon H Guyatt; Per O Vandvik; Rachel Couban; Brent Mollon; Jason W Busse Journal: BMJ Date: 2017-02-22