Splinted Wrist Study

April 24, 2026 updated by: Region Skane

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Malmo, Sweden, 20502
        • Recruiting
        • Emergency department, Malmö university hospital
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • NRS 5-10
  • Suspected distal fracture of radius

Exclusion Criteria:

  • No X-ray veriefied fracture.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Treatment as usual
Active Comparator: SAM splint
Recieves SAM splint for pain relief
Device: SAM splint
Splint vs no splint in paitents awaiting X-ray in the ER.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain assessment
Time Frame: 60 minutes
Self assessed pain according to NRS (numeric rating scale)
60 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
24 hours from enrollment.
Negative impact on radiology
Time Frame: 24 hours from enrollment in study.
Splint artefacts on radiological exam.
24 hours from enrollment in study.
Adverse events
Time Frame: 24 from enrollment in ER.
Side effects from splint
24 from enrollment in ER.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Region Skane

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 14, 2022

Primary Completion (Estimated)

December 30, 2026

Study Completion (Estimated)

December 30, 2027

Study Registration Dates

First Submitted

January 4, 2023

First Submitted That Met QC Criteria

April 24, 2026

First Posted (Actual)

April 27, 2026

Study Record Updates

Last Update Posted (Actual)

April 27, 2026

Last Update Submitted That Met QC Criteria

April 24, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5.1-2022-89331.

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All IDP collected will be shared upon request.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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