Health TrialsbyHealthPanel

Splinted Wrist Study

ConditionsWrist InjuriesWrist FracturePain, Acute
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorRegion Skane

About this trial

Randomized clinical trial comparing SAM aluminium splint vs pain relief as usual in patients seeking emergency department care for suspected wrist fractures.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

NRS 5-10

Suspected distal fracture of radius

Disqualifiers

No X-ray veriefied fracture.

Trial design

Design model

Parallel

Treatments tested in this trial

  • SAM splint

    Device

    Splint vs no splint in paitents awaiting X-ray in the ER.

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: SAM splintActive comparator 1 intervention
Group B: ControlNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Pain assessment

Self assessed pain according to NRS (numeric rating scale)

Time frame
60 minutes

Secondary outcomes

1

Pain relief medication

Between-group comparison of analgesia provided by nursing staff up to 24 hours after presentation at ER.

Time frame
24 hours from enrollment.
2

Negative impact on radiology

Splint artefacts on radiological exam.

Time frame
24 hours from enrollment in study.
3

Adverse events

Side effects from splint

Time frame
24 from enrollment in ER.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Region Skane

Lead sponsor

Source ClinicalTrials.gov
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