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Structural and Functional Nerve Changes Following Immobilisation After Distal Radius Fracture - a Pilot Study (NRP)

NCT02396277 · Status: WITHDRAWN · Type: OBSERVATIONAL

Last updated 2025-05-13

No results posted yet for this study

Summary

Immobilization after radius fracture seems to increase the risk of developing a Complex regional pain syndrome (CRPS), a condition associated with pain, increased skin sensitivity and reduced epidermal nerve density.

The purpose of the study is to determine whether 5-week immobilisation leads to functional and structural sensory changes, and whether the changes are associated with persistent pain. The investigators plan an explorative, pilot study on six consenting patients immobilised after a distal radius fracture.

The baseline measurements will be recorded at the day of or the day after trauma: Demographics, psychological and physical comorbidity, pain characteristics and intensity, hand function, health related quality of life (HRQOL), quantitative sensory testing will be recorded while skin biopsies are analyzed for epidermal nerve fiber density. Following variables such as pain characteristics and intensity, hand function, health related quality of life, quantitative sensory testing and skin biopsies will be reassessed when the cast is removed and two months later.

Conditions

  • Colles' Fracture
  • Distal Radius Fracture

Interventions

PROCEDURE

Immobilization

This is not an intervention study; but the patients are subjected to immobilization with a cast as part of a regular clinical treatment for distal radius fracture.

Sponsors & Collaborators

  • University of Tromso

    lead OTHER

Principal Investigators

  • Gunnvald Kvarstein, PhD · University of Tromso

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-31
Primary Completion
2026-12-31
Completion
2028-12-31

Countries

  • Norway

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02396277 on ClinicalTrials.gov