Referred Pain Areas in Subjects With a Recovered Radius Fracture
Pressure-induced Referred Pain is More Expansive in Individuals With a Recovered Non-painful Fracture
1 other identifier
observational
44
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Oct 2017
Shorter than P25 for all trials
1 active site
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
CompletedFirst Submitted
Initial submission to the registry
April 25, 2018
CompletedFirst Posted
Study publicly available on registry
May 22, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 3, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
September 3, 2018
CompletedOctober 16, 2018
October 1, 2018
10 months
April 25, 2018
October 15, 2018
Conditions
Keywords
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
Control group
This group will receive the same intervention than the recovered fracture group
Interventions
The described procedures are tested at baseline and 24 hours after exercise-induced muscle soreness conditions.
Eligibility Criteria
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
- Universidad San Jorgelead
- Aalborg Universitycollaborator
Study Sites (1)
Universidad San Jorge
Villanueva de Gállego, Zaragoza, 50830, Spain
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Víctor Doménech-García, MSc
Universidad San Jorge
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