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

NCT03871504 | Unknown

• 1 other identifier: HR-2999
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Subjects

Keywords

exercise; hypoalgesia; pain; expectation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Expectation

  Before exercise which will be on day 1 and day 7 of data collection.

• 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.

• 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.

• 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.

Study Arms (2)

submaximal isometric exercise.

EXPERIMENTAL

submaximal isometric exercise will be performed.

Other: Submaximal isometric exercise

Quiet rest.

NO INTERVENTION

Subject will rest in seating position for a period that mimics the exercise time.

Interventions

Submaximal isometric exercise OTHER

The exercise is a submaximal isometric contraction

submaximal isometric exercise.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy adults
• English proficiency

You may not qualify if:

• 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

Sponsors & Collaborators

• Marquette University: lead

Study Sites (1)

Marquette University

Milwaukee, Wisconsin, 53201, United States

RECRUITING

MeSH Terms

Conditions

Motor Activity; Pain

Condition Hierarchy (Ancestors)

Behavior; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Marie Hoeger Bement, PT, PhD

  Marquette University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marie Hoeger Bement, PT, PhD

CONTACT

414-288-6738; mariehoeger.bement@marquette.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants are blinded to the hypothesis of this study.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: December 13, 2018
• First Posted: March 12, 2019
• Study Start: November 25, 2017
• Primary Completion: December 30, 2022
• Study Completion: December 30, 2022
• Last Updated: March 12, 2019

Record last verified: 2019-03

Locations

US (1)