The Influence of Baseline Sensitivity and Expectation on Exercise-induced Hypoalgesia in Young Healthy Adults

Healthy Subjects Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03871504
• Other study ID #: HR-2999
• Status: Recruiting
• Phase: N/A
• Start date: November 25, 2017
• Est. completion date: December 30, 2022

Study information

• Verified date: March 2019
• Source: Marquette University
• Contact: Marie Hoeger Bement, PT, PhD
• Phone: 414-288-6738
• Email: mariehoeger.bement[@]marquette.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: December 30, 2022
• Est. primary completion date: December 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Healthy Subjects

Intervention

Other:
• Submaximal isometric exercise
The exercise is a submaximal isometric contraction

Locations

Country	Name	City	State
United States	Marquette University	Milwaukee	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Marquette University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The change from baseline of pain ratings during temporal summation of pressure pain assessment	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.	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	Expectation	Subjects will be asked about their expectation of whether exercise will increase, decrease, or have no effect on the pain.	Before exercise which will be on day 1 and day 7 of data collection.
Secondary	State version of the State-Trait Anxiety Inventory (STAI)	A 20-item questionnaire from state-trait anxiety inventory that evaluates different feelings the subject may or may not have at the moment. The score of the questionnaire ranges from 0 to 80. Higher scores indicate greater state anxiety levels.	After each temporal summation protocol in the first and second session which are on day 1 and day 7 of data collection.
Secondary	Trait version of the State-Trait Anxiety Inventory (STAI)	A 20-item questionnaire from state-trait anxiety inventory that evaluates how the subject feels in general and not restricted to the current moment. The score of the questionnaire ranges from 0 to 80. Higher scores indicate greater trait anxiety levels.	Baseline (beginning of session 1) which is day 1 of the data collection.
Secondary	Pain catastrophizing scale	A 13-item scale that evaluates if the subject has an exaggerated negative mental set towards pain. It has 3 sub-scales which are magnification, rumination, and helplessness. The scores of the sub-scales are summed to get the total score. The total score ranges from 0 to 52. Greater scores indicate greater catastrophizing thinking.	Baseline (beginning of session 1) which is day 1 of the data collection.
Secondary	Situational pain catastrophizing scale	A 6-item questionnaire that explores the negative mental set or catastrophizing thinking in reference to a particular experimental pain experience (i.e., temporal summation protocol). The score ranges from 0 to 24 with higher scores indicating greater situational catastrophizing.	After each temporal summation protocol in the first and second session which are day 1 and day 7 of data collection.
Secondary	Physical activity assessment using International physical activity questionnaire.	International physical activity questionnaire (IPAQ) will be used to assess physical activity in the past week. IPAQ evaluates physical activity not only related to leisure time but also related to other domains such as transportation, work, gardening or house related physical activities. The questionnaire has been shown to be reliable and valid. The time spent in moderate to vigorous physical activity (minutes/ week) from every domain will be summed with 0 indicating no time (minutes / week) spent moderate to vigorous activities and higher values indicate greater time spent in moderate to vigorous physical activity.	Baseline (beginning of session 1 or 2) which is either day 1 or day 7 of data collection.
Secondary	Muscle mass assessment using Dual-energy x-ray absorptiometry.	Dual-energy x-ray absorptiometry (General Electric Healthcare, Madison, Wisconsin) is an x-ray scan that is used to assess muscle mass.	Baseline (in the first or second session) which is either day 1 or day 7 of data collection.
Secondary	Fat mass assessment using Dual-energy x-ray absorptiometry.	Dual-energy x-ray absorptiometry (General Electric Healthcare, Madison, Wisconsin) is an x-ray scan that is used to assess fat mass.	Baseline (in the first or second session) which is either day 1 or day 7 of data collection.