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Referred Pain Areas in Subjects With a Recovered Radius Fracture

Sponsor
Universidad San Jorge (Other)
Overall Status
Completed
CT.gov ID
NCT03531801
Collaborator
Aalborg University (Other)
44
Enrollment
1
Location
10.1
Actual Duration (Months)
4.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Pressure algometry and mapping referred pain areas

Detailed Description

Musculoskeletal injuries, nociception and pain can increase the sensitivity of the central pain mechanisms, which can be extended even after tissue recovery. However, little is known about the status of these central pain mechanisms once subjects are fully recovered from the tissue injury and pain. This information would help to explain pain conditions in which recurrence of the pain episodes is common (e.g low back pain or shoulder pain).

Pressure-pain thresholds have been widely used in pain research to test the sensitivity of the pain system. Additionally, referred pain has been shown as a valid biomarker for the sensitization of the pain system.

The aim of the present study is to investigate pressure pain sensitivity and referred pain patterns of individuals with a history of recovered fracture, compared with healthy controls.

Study Design

Study Type:
Observational
Actual Enrollment :
44 participants
Observational Model:
Case-Control
Time Perspective:
Cross-Sectional
Official Title:
Pressure-induced Referred Pain is More Expansive in Individuals With a Recovered Non-painful Fracture
Actual Study Start Date :
Oct 30, 2017
Actual Primary Completion Date :
Sep 3, 2018
Actual Study Completion Date :
Sep 3, 2018

Arms and Interventions

Arm Intervention/Treatment
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
The described procedures are tested at baseline and 24 hours after exercise-induced muscle soreness conditions.
Other Names:
  • Delayed onset muscular soreness

    		•
    Control group

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

    Other: Pressure algometry and mapping referred pain areas
    The described procedures are tested at baseline and 24 hours after exercise-induced muscle soreness conditions.
    Other Names:
  • Delayed onset muscular soreness

    		•

    Outcome Measures

    Primary Outcome Measures

    1. A change in the area of referred rain [24 hours (two experimental sessions separated by 24h).]

      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.

    Secondary Outcome Measures

    1. A change in pressure-pain thresholds [24 hours (two experimental sessions separated by 24h).]

      This secondary outcome measure corresponds to the force required to produce a MINIMAL pain(1 out of 10 on a 0-10 visual analogue scale)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Inclusion Criteria:
    • Subjects with a history of distal radius fracture without pain at the moment of the study.
    Exclusion Criteria:
    • Subjects with symptoms (e.g pain), functional limitations, history of other fractures in the upper limb or any other pathology.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Universidad San Jorge Villanueva de Gállego Zaragoza Spain 50830

    Sponsors and Collaborators

    • Universidad San Jorge
    • Aalborg University

    Investigators

    • Principal Investigator: Víctor Doménech-García, MSc, Universidad San Jorge

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Víctor Doménech, Lecturer and Researcher at Universidad San Jorge, Universidad San Jorge
    ClinicalTrials.gov Identifier:
    NCT03531801
    Other Study ID Numbers:
    • PI16/094
    First Posted:
    May 22, 2018
    Last Update Posted:
    Oct 16, 2018
    Last Verified:
    Oct 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Víctor Doménech, Lecturer and Researcher at Universidad San Jorge, Universidad San Jorge
    Referred pain
    pressure algometry
    pain mapping
    Additional relevant MeSH terms:
    Pain, Referred
    Fractures, Bone
    Radius Fractures

    Study Results

    No Results Posted as of Oct 16, 2018