- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04097249
Infrared Thermography for the Diagnosis of Musculoskeletal Pain
September 18, 2019 updated by: Universidad San Jorge
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.
Study Overview
Status
Completed
Conditions
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 Type
Observational
Enrollment (Actual)
20
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 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Participants with no acute pain, chronic pain or other medical disorders relevant to this study.
Description
Inclusion Criteria:
- Being healthy and free from any pain specific to the upper limbs and/or in general.
Exclusion Criteria:
- Previous history of chronic pain.
- Any systemic diseases or regional pathology which can interfere with the outcome measures.
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-Crossover
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
---|
Healthy subjects
Participants free from any pain specific to the upper limb, chronic pain or other disease.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
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.
|
Day-1 (baseline assessment, pre exercise before painful stimulus), Day-2 (24 hours post-exercise before painful stimulus)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Pablo Herrero, PhD, 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 1, 2015
Primary Completion (Actual)
April 29, 2016
Study Completion (Actual)
April 30, 2016
Study Registration Dates
First Submitted
September 18, 2019
First Submitted That Met QC Criteria
September 18, 2019
First Posted (Actual)
September 20, 2019
Study Record Updates
Last Update Posted (Actual)
September 20, 2019
Last Update Submitted That Met QC Criteria
September 18, 2019
Last Verified
September 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- P15/2015
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
IPD Plan Description
There are currently no plan on sharing data from this study with other researchers.
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.
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