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Infrared Thermography for the Diagnosis of Musculoskeletal Pain

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ClinicalTrials.gov Identifier: NCT04097249
Recruitment Status : Completed
First Posted : September 20, 2019
Last Update Posted : September 20, 2019
Sponsor:
Information provided by (Responsible Party):
Universidad San Jorge

Tracking Information
First Submitted Date September 18, 2019
First Posted Date September 20, 2019
Last Update Posted Date September 20, 2019
Actual Study Start Date October 1, 2015
Actual Primary Completion Date April 29, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 18, 2019)
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.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: September 18, 2019)
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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Infrared Thermography for the Diagnosis of Musculoskeletal Pain
Official Title The Contribution and Validity of Infrared Thermography in the Diagnosis of Musculoskeletal Pain
Brief 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.
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 [Patient Registry]
Study Design Observational Model: Case-Crossover
Time Perspective: Cross-Sectional
Target Follow-Up Duration 2 Days
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Participants with no acute pain, chronic pain or other medical disorders relevant to this study.
Condition
  • Healthy
  • Pain
  • Temperature Change, Body
Intervention Not Provided
Study Groups/Cohorts Healthy subjects
Participants free from any pain specific to the upper limb, chronic pain or other disease.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: September 18, 2019)
20
Original Actual Enrollment Same as current
Actual Study Completion Date April 30, 2016
Actual Primary Completion Date April 29, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT04097249
Other Study ID Numbers P15/2015
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Plan Description: There are currently no plan on sharing data from this study with other researchers.
Responsible Party Universidad San Jorge
Study Sponsor Universidad San Jorge
Collaborators Not Provided
Investigators
Study Director: Pablo Herrero, PhD Universidad San Jorge
PRS Account Universidad San Jorge
Verification Date September 2019