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Recruiting NCT07553000

Splinted Wrist Study

No phase Interventional Wrist Injuries Wrist Fracture Pain, Acute

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: SAM splint.
Who it may be relevant to
Registry conditions: Wrist Injuries, Wrist Fracture, Pain, Acute. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Sweden
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official 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.

Overview

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

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

Interventions

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

Primary outcome measures

  • Pain assessment [Time frame: 60 minutes]
Secondary outcome measures (3)
  • Pain relief medication [Time frame: 24 hours from enrollment.]
  • Negative impact on radiology [Time frame: 24 hours from enrollment in study.]
  • Adverse events [Time frame: 24 from enrollment in ER.]

Eligibility criteria

Inclusion criteria

  • NRS 5-10
  • Suspected distal fracture of radius

Exclusion criteria

  • No X-ray veriefied fracture.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Sweden · 1 center
  • Emergency department, Malmö university hospital — Malmö

Identifiers

NCT: NCT07553000 · 5.1-2022-89331.

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗