Radius FracturesNCT03531801
Referred Pain Areas in Subjects With a Recovered Radius Fracture
An observational study of Radius Fractures, run by Universidad San Jorge at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Radius Fractures
- What is being tested?
- Pressure algometry and mapping referred pain areas
- How many people
- 44 participants
- Where
- 1 siteSpain
- Study dates
- 30 Oct 2017to 3 Sep 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Adult, Older adult
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.
Who may be able to join
- Subjects with a history of distal radius fracture without pain at the moment of the study.
Who cannot join
- Subjects with symptoms (e.g pain), functional limitations, history of other fractures in the upper limb or any other pathology.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Radius Fractures
- Being tested
- Pressure algometry and mapping referred pain areas
- Keywords
- Referred pain, pressure algometry, pain mapping
- Medical subject headings
- Radius Fractures, Pain, Referred
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pressure algometry and mapping referred pain areasOther
Also called Delayed onset muscular soreness
The described procedures are tested at baseline and 24 hours after exercise-induced muscle soreness conditions.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Pressure algometry and mapping referred pain areas | |
| Control group | This group will receive the same intervention than the recovered fracture group Receives: Other: Pressure algometry and mapping referred pain areas |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 hours (two experimental sessions separated by 24h).
Secondary outcomes (1)
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)
Measured: 24 hours (two experimental sessions separated by 24h).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2018
- Study start30 Oct 2017
- Primary completion3 Sep 2018
- Study completion3 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radius FracturesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad San Jorge
- Sponsor type
- University, hospital or other
- Collaborators
- Aalborg University
- Responsible party
- Principal investigator, Víctor Doménech, Universidad San Jorge
- Investigators
- Víctor Doménech-García, MSc, Principal investigator, Universidad San Jorge
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03531801
- Sponsor's protocol ID
- PI16/094
- Status last verified
- Oct 2018
- First submitted
- 25 Apr 2018
- Last updated
- 16 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan at the moment
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pressure-induced Referred Pain is More Expansive in Individuals With a Recovered Non-painful Fracture
- ClinicalTrials.gov ID
- NCT03531801
- Acronym / sponsor ID
- PI16/094
- Conditions
- Radius Fractures
- Keywords
- Referred pain, pressure algometry, pain mapping
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Universidad San JorgeUniversity, hospital or other
- Collaborators
- Aalborg University
- Study start
- 30 Oct 2017 (actual)
- Primary completion
- 3 Sep 2018 (actual)
- Study completion
- 3 Sep 2018 (actual)
- First posted
- 22 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Recovered fracture group | – | Other: Pressure algometry and mapping referred pain areasThe 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 | – | Other: Pressure algometry and mapping referred pain areasThis group will receive the same intervention than the recovered fracture group |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Subjects with a history of distal radius fracture without pain at the moment of the study.
Key exclusion criteria (1 listed)
- Subjects with symptoms (e.g pain), functional limitations, history of other fractures in the upper limb or any other pathology.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pressure algometry and mapping referred pain areasAlso: Delayed onset muscular sorenessThe described procedures are tested at baseline and 24 hours after exercise-induced muscle soreness conditions. | Other | Control group, Recovered fracture group |
Primary outcome
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.
1 secondary outcome
A change in pressure-pain thresholds
Time frame: 24 hours (two experimental sessions separated by 24h).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2018.
- Individual participant dataSharing planned: No. There is no plan at the moment
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Víctor Doménech-García, MSc principal investigator
Universidad San Jorge
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Radius Fractures, run by Universidad San Jorge at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
A change in the area of referred rain (time frame: 24 hours (two experimental sessions separated by 24h).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2018.