NCT03531801

Brief Summary

The purpose of the present study is to investigate pressure algometry and pressure-induced referred pain areas in pain free individuals with a history of distal radius fracture (fully recovered) compared with age and gender matched healthy controls without history of fracture. It is hypothesized that individuals with a recovered radius fracture will have a facilitated referred pain patter towards the wrist but normal pressure pain sensitivity.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 30, 2017

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

April 25, 2018

Completed
27 days until next milestone

First Posted

Study publicly available on registry

May 22, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 3, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 3, 2018

Completed
Last Updated

October 16, 2018

Status Verified

October 1, 2018

Enrollment Period

10 months

First QC Date

April 25, 2018

Last Update Submit

October 15, 2018

Conditions

Keywords

Referred painpressure algometrypain mapping

Outcome Measures

Primary Outcomes (1)

  • A change in the area of referred rain

    This outcome measure corresponds to the difference or change in the size and distribution of the pressure-induced referred pain area, between the two experimental sessions.

    24 hours (two experimental sessions separated by 24h).

Secondary Outcomes (1)

  • A change in pressure-pain thresholds

    24 hours (two experimental sessions separated by 24h).

Study Arms (2)

Recovered fracture group

The interventions will be conducted on both groups, on two experimental (approximately 45 minutes per session) sessions separated by 24 hours.Pressure algometry consists of measuring pressure pain thresholds at three bilateral muscle sites.Mapping referred pain areas consists of recording on an electronic body chart the area of pain induced by 60s pressure stimulation at 1.2 times the force needed to reach the pressure pain threshold, exerted on the extensor carpi radialis and the infraspinatus muscles.As group-differences can be attenuated at baseline but emerge on a sensitized (exercise-induced soreness) state, these procedures are performed at baseline and 24 hours after evoking exercise-induced muscle soreness. For further clarification see our recent publication PMID:29608510

Other: Pressure algometry and mapping referred pain areas

Control group

This group will receive the same intervention than the recovered fracture group

Other: Pressure algometry and mapping referred pain areas

Interventions

The described procedures are tested at baseline and 24 hours after exercise-induced muscle soreness conditions.

Also known as: Delayed onset muscular soreness
Control groupRecovered fracture group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Subjects with a history of distal radius fracture without pain at the moment of the study or any physical sequelae derived from the fracture.

You may qualify if:

  • Subjects with a history of distal radius fracture without pain at the moment of the study.

You may not qualify if:

  • Subjects with symptoms (e.g pain), functional limitations, history of other fractures in the upper limb or any other pathology.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad San Jorge

Villanueva de Gállego, Zaragoza, 50830, Spain

Location

MeSH Terms

Conditions

Radius FracturesPain, Referred

Condition Hierarchy (Ancestors)

Forearm InjuriesArm InjuriesWounds and InjuriesFractures, BonePainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Víctor Doménech-García, MSc

    Universidad San Jorge

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer and Researcher at Universidad San Jorge

Study Record Dates

First Submitted

April 25, 2018

First Posted

May 22, 2018

Study Start

October 30, 2017

Primary Completion

September 3, 2018

Study Completion

September 3, 2018

Last Updated

October 16, 2018

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share

There is no plan at the moment

Locations