HealthyNCT04097249
Infrared Thermography for the Diagnosis of Musculoskeletal Pain
An observational study of Healthy and Pain, run by Universidad San Jorge.
Trial summary
This study sought to evaluate the vasomotor response in the pain referral area of healthy individuals, performing the same procedure with and without the experience of delayed onset muscle soreness. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Pain, Temperature Change, Body
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2015to 30 Apr 2016
- How long will I take part?
- 2 Days
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants with no acute pain, chronic pain or other medical disorders relevant to this study.
Who may be able to join
- Being healthy and free from any pain specific to the upper limbs and/or in general.
Who cannot join
- Previous history of chronic pain.
- Any systemic diseases or regional pathology which can interfere with the outcome measures.
About this study
Official title: The Contribution and Validity of Infrared Thermography in the Diagnosis of Musculoskeletal Pain
This study sought to evaluate the vasomotor response in the pain referral area of healthy individuals, performing the same procedure with and without the experience of delayed onset muscle soreness.
Read the detailed description
Validity of infrared thermography for properly diagnosing musculoskeletal pain and their clinical applicability is lacking. This study investigates temperature changes on the upper extremity before and after a suprathreshold stimulation (painful stimulus) with a digital algometer over the infraspinatus muscle. The same procedure is performed in two consecutive days, 24 hours apart (Day-1 and Day-2). At the end of Day-1, an eccentric exercise is performed in order to to induce delayed onset muscle soreness on the external rotators of the shoulder.
- Conditions
- Healthy, Pain, Temperature Change, Body
- Keywords
- Musculoskeletal pain, Delayed Onset Muscle Soreness, Pain sensitivity, Infrared thermography, Referred pain
- Medical subject headings
- Pain, Body Temperature Changes, Musculoskeletal Pain, Pain, Referred
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Healthy subjects | Participants free from any pain specific to the upper limb, chronic pain or other disease. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in temperature of pixels on the upper extremity: infrared thermography
A thermography image of the upper extremity of the body will be taken on both days of assessment before and after applying a painful stimulus. Changes in colour pixels will be analysed to determine temperature changes.
Measured: Day-1 (baseline assessment, pre exercise before painful stimulus), Day-1 (baseline assessment, pre exercise after painful stimulus), Day-2 (24 hours post-exercise before painful stimulus), Day-2 (24 hours post-exercise after painful stimulus)
Secondary outcomes (1)
Changes in Pressure Pain Thresholds: pressure algometry
Changes in pressure pain thresholds will be determined with pressure algometry over the infraspinatus muscle. Pressure Pain Threshold is defined as the exact time point where the pressure is first being perceived as painful.
Measured: Day-1 (baseline assessment, pre exercise before painful stimulus), Day-2 (24 hours post-exercise before painful stimulus)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2019
- Study start1 Oct 2015
- Primary completion29 Apr 2016
- Study completion30 Apr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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 crossover
- Time perspective
- Cross-sectional
- Enrolment
- 20 participants (actual)
- Target duration
- 2 Days
Sponsor and investigators
- Lead sponsor
- Universidad San Jorge
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pablo Herrero, PhD, Study director, Universidad San Jorge
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04097249
- Sponsor's protocol ID
- P15/2015
- Status last verified
- Sep 2019
- First submitted
- 18 Sep 2019
- Last updated
- 20 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There are currently no plan on sharing data from this study with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Contribution and Validity of Infrared Thermography in the Diagnosis of Musculoskeletal Pain
- ClinicalTrials.gov ID
- NCT04097249
- Acronym / sponsor ID
- P15/2015
- Conditions
- Healthy, Pain, Temperature Change, Body
- Keywords
- Musculoskeletal pain, Delayed Onset Muscle Soreness, Pain sensitivity, Infrared thermography, Referred pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Universidad San JorgeUniversity, hospital or other
- Study start
- 1 Oct 2015 (actual)
- Primary completion
- 29 Apr 2016 (actual)
- Study completion
- 30 Apr 2016 (actual)
- First posted
- 20 Sep 2019 (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.
This study sought to evaluate the vasomotor response in the pain referral area of healthy individuals, performing the same procedure with and without the experience of delayed onset muscle soreness.
Detailed description
Validity of infrared thermography for properly diagnosing musculoskeletal pain and their clinical applicability is lacking. This study investigates temperature changes on the upper extremity before and after a suprathreshold stimulation (painful stimulus) with a digital algometer over the infraspinatus muscle. The same procedure is performed in two consecutive days, 24 hours apart (Day-1 and Day-2). At the end of Day-1, an eccentric exercise is performed in order to to induce delayed onset muscle soreness on the external rotators of the shoulder.
Study design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Target follow-up
- 2 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy subjects | – | –Participants free from any pain specific to the upper limb, chronic pain or other disease. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants with no acute pain, chronic pain or other medical disorders relevant to this study.
Key inclusion criteria (1 listed)
- Being healthy and free from any pain specific to the upper limbs and/or in general.
Key exclusion criteria (2 listed)
- Previous history of chronic pain.
- Any systemic diseases or regional pathology which can interfere with the outcome measures.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Changes in temperature of pixels on the upper extremity: infrared thermography
Time frame: Day-1 (baseline assessment, pre exercise before painful stimulus), Day-1 (baseline assessment, pre exercise after painful stimulus), Day-2 (24 hours post-exercise before painful stimulus), Day-2 (24 hours post-exercise after painful stimulus)
A thermography image of the upper extremity of the body will be taken on both days of assessment before and after applying a painful stimulus. Changes in colour pixels will be analysed to determine temperature changes.
1 secondary outcome
Changes in Pressure Pain Thresholds: pressure algometry
Time frame: Day-1 (baseline assessment, pre exercise before painful stimulus), Day-2 (24 hours post-exercise before painful stimulus)
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 20 Sep 2019.
- Individual participant dataSharing planned: No. There are currently no plan on sharing data from this study with other researchers.
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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.
Pablo Herrero, PhD study director
Universidad San Jorge
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy and Pain, run by Universidad San Jorge.
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 2 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 20 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Changes in temperature of pixels on the upper extremity: infrared thermography (time frame: Day-1 (baseline assessment, pre exercise before painful stimulus), Day-1 (baseline assessment, pre exercise after painful stimulus), Day-2 (24 hours post-exercise before painful stimulus), Day-2 (24 hours post-exercise after painful stimulus)). 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 20 Sep 2019.