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

NCT02396277 | Withdrawn

• 1 other identifier: 2014/86 (REK)
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• Changes from baseline in nerve fiber density at five weeks

  ANOVA repeated measurements based on repeated skin biopsies

  From baseline to five weeks after injury

• Changes from baseline in sensitivity to thermal and tactile stimuli at five weeks

  ANOVA repeated measurements based on repeated sensory quantitative testing

  From baseline to five weeks after injury

Secondary Outcomes (6)

• Changes from five weeks in nerve fiber density at 13 weeks

  From five weeks to 13 weeks after injury

• Changes from five weeks in sensitivity to thermal and tactile stimuli at 13 weeks

  From five to 13 weeks after injury

• Correlation between changes in pain intensity and changes in nerve fiber density

  From baseline to 13 weeks

• Correlation between changes in pain intensity and changes in sensitivity to thermal and tactile stimuli

  From baseline to 13 weeks

• Changes from baseline (preinjury) in disability of arm, shoulder and hand are correlated with changes in pain intensity at five and 13 weeks

  From baseline to 13 weeks

Interventions

Immobilization PROCEDURE

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.

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients referred to the Emergency Clinic at The University Hospital in North Norway Tromso day time

You may qualify if:

• Consent competence
• Acute stable distal radius fracture (less than 48 hours)
• Allocated to conservative treatment with 5-week immobilization

You may not qualify if:

• Comorbidity which may prevent completion of the study
• Serious and progressive disease
• Chronic shoulder disease with limited ROM and function.
• Sign peripheral nerve injury in the upper extremities
• Polyneuropathy
• Demyelination disease
• Diabetes mellitus
• Anticoagulants including acetyl salicylic acid (ASA)
• Allergy to local anesthetics

Sponsors & Collaborators

• University of Tromso: lead

Study Sites (1)

University Hospital of North Norway

Tromsø, 9019, Norway

Location

MeSH Terms

Conditions

Colles' Fracture; Wrist Fractures

Interventions

Immobilization

Condition Hierarchy (Ancestors)

Fracture Dislocation; Joint Dislocations; Joint Diseases; Musculoskeletal Diseases; Wounds and Injuries; Radius Fractures; Fractures, Bone; Wrist Injuries; Arm Injuries

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Gunnvald Kvarstein, PhD

  University of Tromso

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2015
• First Posted: March 24, 2015
• Study Start: May 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2028
• Last Updated: May 13, 2025

Record last verified: 2025-05

Locations

NO (1)