Clinical trial NCT03871504: The Influence of Baseline Sensitivity and Expectation on Exercise-induced Hypoalgesia in Young Healthy Adults
Official title: Quantitative Sensory Testing, Physical Activity, and Body Composition in Adults
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Healthy Subjects
Keywords: exercise
hypoalgesia
pain
expectation
Lead sponsor: Marquette University
Sponsor class: OTHER
First posted: 2019-03-12
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: All subjects will participate in two randomized sessions (an exercise session and control session). The exercise session consists of submaximal isometric exercise while the quiet rest session consists of a rest for a period that mimics the time spent in exercise.
Primary purpose: TREATMENT

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.

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
* Diabetes
* Smoking
* Raynaud disease
* Claustrophobia

Primary outcomes:
measure: The change from baseline of pain ratings during temporal summation of pressure pain assessment
timeFrame: 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.
Secondary outcomes:
measure: Expectation
timeFrame: Before exercise which will be on day 1 and day 7 of data collection.
measure: State version of the State-Trait Anxiety Inventory (STAI)
timeFrame: After each temporal summation protocol in the first and second session which are on day 1 and day 7 of data collection.
measure: Trait version of the State-Trait Anxiety Inventory (STAI)
timeFrame: Baseline (beginning of session 1) which is day 1 of the data collection.
measure: Pain catastrophizing scale
timeFrame: Baseline (beginning of session 1) which is day 1 of the data collection.
measure: Situational pain catastrophizing scale
timeFrame: After each temporal summation protocol in the first and second session which are day 1 and day 7 of data collection.
measure: Physical activity assessment using International physical activity questionnaire.
timeFrame: Baseline (beginning of session 1 or 2) which is either day 1 or day 7 of data collection.
measure: Muscle mass assessment using Dual-energy x-ray absorptiometry.
timeFrame: Baseline (in the first or second session) which is either day 1 or day 7 of data collection.
measure: Fat mass assessment using Dual-energy x-ray absorptiometry.
timeFrame: Baseline (in the first or second session) which is either day 1 or day 7 of data collection.
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: Marquette University
state: Wisconsin
Study officials:
affiliation: Marquette University
name: Marie Hoeger Bement, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References: