Referred Pain Areas in Subjects With a Recovered Radius Fracture

October 15, 2018 updated by: Víctor Doménech, Universidad San Jorge

Pressure-induced Referred Pain is More Expansive in Individuals With a Recovered Non-painful Fracture

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

44

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Zaragoza
      • Villanueva de Gállego, Zaragoza, Spain, 50830
        • Universidad San Jorge

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
A change in the area of referred rain
Time Frame: 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.
24 hours (two experimental sessions separated by 24h).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
A change in pressure-pain thresholds
Time Frame: 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)
24 hours (two experimental sessions separated by 24h).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 30, 2017

Primary Completion (Actual)

September 3, 2018

Study Completion (Actual)

September 3, 2018

Study Registration Dates

First Submitted

April 25, 2018

First Submitted That Met QC Criteria

May 8, 2018

First Posted (Actual)

May 22, 2018

Study Record Updates

Last Update Posted (Actual)

October 16, 2018

Last Update Submitted That Met QC Criteria

October 15, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

There is no plan at the moment

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Radius Fractures

Clinical Trials on Pressure algometry and mapping referred pain areas

Subscribe