NCT05525403

Brief Summary

The primary purpose of this study is to compare immediate changes in pain sensitivity (pressure pain threshold) during quiet rest, low fatigue exercise, and high fatigue exercise.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
31

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
Completed

Started Oct 2022

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 22, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 1, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

October 28, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 20, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 20, 2023

Completed
Last Updated

April 24, 2023

Status Verified

April 1, 2023

Enrollment Period

6 months

First QC Date

August 22, 2022

Last Update Submit

April 20, 2023

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • Change in Pressure Pain Threshold

    A digital pressure algometer will be applied to the quadriceps and upper trapezius for two trials each. Participants are instructed to say "stop" or "pain" so the stimulus can be terminated "when the sensation first transitions from pressure to pain" (pain threshold). Participants will rate the pain experienced during the threshold testing using a 101-point numeric pain rate scale (NPRS) anchored with 0= no pain to 100= the most intense pain sensation imaginable immediately following each testing time.

    Change from baseline immediately after exercise

Secondary Outcomes (10)

  • Temporal Summation

    Baseline, pre exercise

  • Heat Pain Threshold

    Baseline, pre exercise

  • Conditioned Pain Modulation

    Baseline, pre exercise

  • International Physical Activity Questionnaire Short Form

    Baseline, pre exercise

  • Pittsburgh Sleep Quality Index

    Baseline, pre exercise

  • +5 more secondary outcomes

Other Outcomes (1)

  • 1-repetition maximum testing

    Baseline, pre exercise

Study Arms (3)

Low Fatigue Exercise

EXPERIMENTAL

Participants will complete a single leg knee extension exercise with weight until they report a fatigue level = 3/10 on the Borg Rating of Perceived Exertion. Participants will complete three sets.

Other: Knee Extension Exercise

High Fatigue Exercise

EXPERIMENTAL

Participants will complete a single leg knee extension exercise with weight until they report a fatigue level = 8/10 on the Borg Rating of Perceived Exertion. Participants will complete three sets.

Other: Knee Extension Exercise

Quiet Rest

ACTIVE COMPARATOR

Participants will rest quietly for two minutes, three sets.

Other: Quiet Rest

Interventions

Knee Extension ExerciseOTHER

Participants will be seated in a Steel Flex machine with weight equal to 50% of their 1 repetition maximum added to the machine. Participants will extend the dominant knee until the assigned fatigue level.

High Fatigue ExerciseLow Fatigue Exercise
Quiet RestOTHER

Participants will sit quietly for two minutes, three times.

Quiet Rest

Eligibility Criteria

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

You may qualify if:

  • Pain-free
  • years old
  • Participant can appropriately perform the knee extension exercise (assessed during screening)

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
  • Systemic medical condition known to affect sensation, such as uncontrolled diabetes or neurological conditions
  • Any contraindication to the application of ice, such as: uncontrolled hypertension (blood pressure over 140/90 mmHg), cold urticaria, cryoglobulinemia, paroxysmal cold hemoglobinuria, circulatory compromise
  • Known presence of cardiovascular, pulmonary, or metabolic disease
  • Current use of tobacco products
  • Not physically ready to exercise without a medical exam as indicated by the Physical Activity Readiness Questionnaire Plus (PAR-Q+)
  • Surgery, injury, or fracture to the lower back or lower extremity 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 Officials

  • Abigail Wilson

    University of Central Florida

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

August 22, 2022

First Posted

September 1, 2022

Study Start

October 28, 2022

Primary Completion

April 20, 2023

Study Completion

April 20, 2023

Last Updated

April 24, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)