- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03531801
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
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Contacts and Locations
Study Locations
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Zaragoza
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Villanueva de Gállego, Zaragoza, Spain, 50830
- Universidad San Jorge
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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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
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The described procedures are tested at baseline and 24 hours after exercise-induced muscle soreness conditions.
Other Names:
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Control group
This group will receive the same intervention than the recovered fracture group
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The described procedures are tested at baseline and 24 hours after exercise-induced muscle soreness conditions.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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A change in the area of referred rain
Time Frame: 24 hours (two experimental sessions separated by 24h).
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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.
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24 hours (two experimental sessions separated by 24h).
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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A change in pressure-pain thresholds
Time Frame: 24 hours (two experimental sessions separated by 24h).
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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)
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24 hours (two experimental sessions separated by 24h).
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Víctor Doménech-García, MSc, Universidad San Jorge
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PI16/094
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
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