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NCT Number: NCT07553000

Splinted Wrist Study

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

Recruiting

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Key information

Conditions

Wrist Injuries Acute Pain Arm Injuries Fractures, Bone Neurologic Manifestations Pain Pain, Acute Pathological Conditions, Signs and Symptoms Signs and Symptoms Wounds and Injuries Wrist Fracture Wrist Fractures

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

Randomized controlled trial of suspected wrist fractures in patients seeking emergency department care. Comparison of pain relief. Randomized to standard care or standard care + aluminium splint.

Primary outcome: Numeric rating scale (NRS) pain rating at 1 hour. Secondary outcomes: Pain medication usage between groups. Negative impact on radiology results.

Safety endpoint: Reported side effects

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • NRS 5-10
  • Suspected distal fracture of radius

Exclusion criteria

  • No X-ray veriefied fracture.

Treatment and study plan

SAM splint

Device

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

Primary outcomes

  1. Pain assessment

    Time frame: 60 minutes

    Self assessed pain according to NRS (numeric rating scale)

Secondary outcomes

  1. Pain relief medication

    Time frame: 24 hours from enrollment.

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

  2. Negative impact on radiology

    Time frame: 24 hours from enrollment in study.

    Splint artefacts on radiological exam.

  3. Adverse events

    Time frame: 24 from enrollment in ER.

    Side effects from splint

Sponsors and collaborators

Lead sponsor

Region Skane

Other

Registry information

Official study title

The Additional Pain Relieving Benefit of Using a Splint in Suspected Wrist Fractures in Adult Patients at an Emergency Department - a Randomized Controlled Trial.

Important dates

Study start
2022
Primary completion
2026
Study completion
2027
First posted
Apr 27, 2026
Registry last updated
Apr 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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