NCT06050889

Brief Summary

Exercise-Induced Hypoalgesia (EIH) is a lessening of pain sensitivity in response to an acute bout of exercise. Limited research has examined the effects of expectations on EIH during a dynamic resistance training during different intensities. Therefore, the purpose of this study is to examine the effects of positive and negative expectations on EIH.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for not_applicable healthy

Timeline
Completed

Started Nov 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 15, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 22, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

November 14, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 19, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 19, 2024

Completed
Last Updated

April 22, 2024

Status Verified

April 1, 2024

Enrollment Period

5 months

First QC Date

September 15, 2023

Last Update Submit

April 19, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Pressure Pain Threshold

    Pressure Pain Threshold will be applied with a digital algometer before and after the exercise intervention.

    Change from baseline immediately after exercise

Study Arms (2)

High Intensity Exercise

EXPERIMENTAL

Participants will complete an upper body resistance exercise until they report a high fatigue level.

Other: Positive Expectations Instructional SetOther: Negative Expectations Instructional Set

Low Intensity Exercise

EXPERIMENTAL

Participants will complete an upper body resistance exercise until they report a low fatigue level.

Other: Positive Expectations Instructional SetOther: Negative Expectations Instructional Set

Interventions

Participants randomly assigned to this instructional set will be told, "You will be completing an intervention known to be effective for some people with shoulder pain. We expect this will make you less sensitive to the pressure applied to your shoulder and thigh and you will require more pressure than what was previously necessary to experience pain."

High Intensity ExerciseLow Intensity Exercise

Participants randomly assigned to this instructional set will be told, "You will be completing an intervention which is not effective for some people with shoulder pain. We expect this will make you more sensitive to the pressure applied to your shoulder and thigh and you will require less pressure than what was previously necessary to experience pain."

High Intensity ExerciseLow Intensity Exercise

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Pain Free

You may not qualify if:

  • Non-English speaking
  • Regular use of prescription pain medications
  • Current or history of chronic pain condition
  • Currently taking blood-thinning medication
  • Any blood clotting disorder, such as hemophilia
  • Systemic medical condition known to affect sensation, such as uncontrolled diabetes or neurological conditions
  • Not physically ready to exercise without a medical exam as indicated by the Physical Activity Readiness Questionnaire Plus (PAR-Q+)
  • Not have had Surgery, injury, or fracture within the past 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Central Florida

Orlando, Florida, 32765, United States

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

September 15, 2023

First Posted

September 22, 2023

Study Start

November 14, 2023

Primary Completion

April 19, 2024

Study Completion

April 19, 2024

Last Updated

April 22, 2024

Record last verified: 2024-04

Locations