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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03531801
Other study ID # PI16/094
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 30, 2017
Est. completion date September 3, 2018

Study information

Verified date October 2018
Source Universidad San Jorge
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 44
Est. completion date September 3, 2018
Est. primary completion date September 3, 2018
Accepts healthy volunteers
Gender All
Age group 18 Years to 80 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Spain Universidad San Jorge Villanueva de Gállego Zaragoza

Sponsors (2)

Lead Sponsor Collaborator
Universidad San Jorge Aalborg University

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 A change in pressure-pain thresholds 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).
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