Lubbert 2008.

Methods	Study design: multicentre, double‐blind RCT Duration of the study: March 2001 and December 2003 Protocol was published before recruitment of patients: not reported Details of trial registration: not reported Intention‐to‐treat analysis: Likely, but data of those patients who withdrew could not be collected Funding sources: data collection and data analysis were supported by a financial grant from Smith and Nephew Inc, Memphis, USA. Transducers (placebo and active) were provided free of cost. No author had any financial or personal relationships with people or organisations that could inappropriately influence their work
Participants	Location: 6 hospitals in the Netherlands participated in the study (Meander Medical Centre, Amersfoort; Onze Lieve Vrouwen Gasthuis Hospital, Amsterdam; Reinier de Graaf Hospital, Delft; Saint Antonius Hospital, Nieuwegein; Diakonessen Hospital, Utrecht; University Medical Centre Utrecht, Utrecht) Number of participants assigned: 120 (61 LIPUS; 59 control (placebo)) Number of participants assessed: 101 (52 LIPUS; 49 control (placebo)) Inclusion criteria: People with middle third clavicle fractures Acute fracture (< 5 days) Aged ≥ 18 years Monotrauma Understanding of Dutch language and written informed consent Exclusion criteria: Aged < 18 years Multiple trauma Re‐fracture Pathological fracture Open fracture or imminent skin perforation Metaphysis fracture No possibilities for follow‐up *Age (mean/SD): LIPUS: 37.7; 12.9 Control (placebo): 36.9; 12.3 Gender (male/female): LIPUS: 46/6 Control (placebo): 39/10 Side (left/right): LIPUS: 32/20 Control (placebo): 22/27 Classification of injury: AO system (A1, A2, A3, B1, B2, B3, C1, C2, C3)
Interventions	Timing of intervention: up to 5 days after the diagnosis Intervention 1 (LIPUS: low‐intensity pulsed ultrasound): LIPUS delivers an ultrasound signal intensity of 30 mW/cm² SATA, with a burst width of 200 µs in 1.5 MHz sine waves, pulsed at 1 kHz Intervention 2 (placebo): Control (placebo): transducers produced no signal, but showed similar messages on the display screen and could not be distinguished from active transducers Duration of treatment (mean): LIPUS = 25.38 days; control (placebo) = 24.43 days (mean difference 0.95, 95% CI ‐3.72 to +1.81, P = 0.49) Rehabilitation: it was not done All participants were treated with passive support for their own convenience. Free arm movements within pain range were allowed from day 1 Any co‐interventions: not reported
Outcomes	Length of follow‐up: Length of follow‐up (mean): LIPUS 29.6 months and placebo 30.1 months, ranged between 12 and 43 months* All participants were seen in the outpatient clinic approximately 1 week after starting the treatment and again roughly 2, 4, 6 and 8 weeks after trauma Loss of follow‐up: 9 participants lost to follow‐up: LIPUS group ‐ nine participants lost to follow‐up: Diary not completely filled (9 participants) Control (placebo) group ‐ 10 participant lost to follow‐up: Diary not completely filled (7 participants) Transducer failure (3 participants) Primary outcomes: Pain: VAS from zero to 10 (best to worst) and analgesics consumption Treatment failure Secondary outcomes: Clinical healing (time to consolidation) Adverse events: skin irritation (other "minor adverse side effects" not enumerated) Time to return to household activities, work and sport
Notes	*Data assessed by personal contact with the authors
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Block randomisation was used
Allocation concealment (selection bias)	Low risk	Double‐blind, randomised, placebo‐controlled trial Each participating hospital was delivered consecutive numbered transducers in packs of 4 (2 LIPUS and 2 placebos)
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Participants and personnel were blinded
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Outcomes assessors were blinded
Incomplete outcome data (attrition bias) All outcomes	Low risk	More than 80% of participants completed the follow‐up, missing outcomes data were balanced in number across intervention groups, and an intention‐to‐treat analysis was reported for the primary outcomes; however, data for those patients who withdrew were not reported
Selective reporting (reporting bias)	High risk	The study protocol is not available and function and/or disability were not evaluated using a validated score
Other bias	Low risk	The study appears to be free of other sources of bias

<: less than
 >: more than
 ≥: more or equal to
 AO: Arbeitsgemeinschaft für Osteosynthesefragen
 CI: confidence interval
 DVT: deep‐venous thrombosis
 ITT: intention‐to‐treat
 LIPUS: low‐intensity pulsed ultrasound
 kHz: kilohertz
 MHz: megahertz
 mW/cm²: milliWatt per square centimetre
 µs: microsecond
 RCT: randomised controlled trial
 SATA: spatial average, temporal average
 VAS: visual analogue scale