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Clinical Trials/NCT03871504
NCT03871504
Unknown
N/A

Quantitative Sensory Testing, Physical Activity, and Body Composition in Adults

Marquette University1 site in 1 country250 target enrollmentNovember 25, 2017

Overview

Phase
N/A
Intervention
Not specified
Conditions
Healthy Subjects
Sponsor
Marquette University
Enrollment
250
Locations
1
Primary Endpoint
The change from baseline of pain ratings during temporal summation of pressure pain assessment
Last Updated
7 years ago

Overview

Brief Summary

The purpose of this study is to investigate the influence of baseline experimental pain sensitivity and expectation on the pain response following a single exercise session. Pain assessment will be done with different intensities of noxious stimuli. In addition, the expectation of how exercise impacts pain will be studied.

Detailed Description

The relation between baseline pain sensitivity and the pain response following exercise is not clear. The aims of this study are to investigate the influence of baseline experimental pain sensitivity on the pain response following submaximal isometric exercise, and whether expectations would influence outcomes with subsequent exposure to exercise.

Registry
clinicaltrials.gov
Start Date
November 25, 2017
End Date
December 30, 2022
Last Updated
7 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Healthy adults
  • English proficiency

Exclusion Criteria

  • Acute pain condition
  • Chronic pain condition
  • Mental health disorder
  • Cardiovascular disease
  • Any chronic illness
  • Difficulty with physical exercise
  • Recent surgery
  • Pulmonary disease
  • Raynaud disease
  • Claustrophobia

Outcomes

Primary Outcomes

The change from baseline of pain ratings during temporal summation of pressure pain assessment

Time Frame: Before and immediately after exercise or quiet rest in session 1 and session 2 which will be on day 1 and day 7 of data collection.

Temporal summation is the increase of pain over time caused by a constant or repetitive noxious stimulus. Pain reports will be obtained during the application of constant mechanical stimulus with various intensities. Subjects will be asked to rate the pain using a numerical pain rating scale that ranges from 0 (no pain) to 10 (worst pain). Pain ratings will be obtained at the beginning, during, and at the end of the test while a noxious stimulus is applied to the index finger. The change of pain ratings relative to baseline after exercise or quiet rest will be assessed.

Secondary Outcomes

  • State version of the State-Trait Anxiety Inventory (STAI)(After each temporal summation protocol in the first and second session which are on day 1 and day 7 of data collection.)
  • Expectation(Before exercise which will be on day 1 and day 7 of data collection.)
  • Fat mass assessment using Dual-energy x-ray absorptiometry.(Baseline (in the first or second session) which is either day 1 or day 7 of data collection.)
  • Trait version of the State-Trait Anxiety Inventory (STAI)(Baseline (beginning of session 1) which is day 1 of the data collection.)
  • Pain catastrophizing scale(Baseline (beginning of session 1) which is day 1 of the data collection.)
  • Muscle mass assessment using Dual-energy x-ray absorptiometry.(Baseline (in the first or second session) which is either day 1 or day 7 of data collection.)
  • Situational pain catastrophizing scale(After each temporal summation protocol in the first and second session which are day 1 and day 7 of data collection.)
  • Physical activity assessment using International physical activity questionnaire.(Baseline (beginning of session 1 or 2) which is either day 1 or day 7 of data collection.)

Study Sites (1)

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