NCT05561582

Brief Summary

The primary purpose of this study is to to compare immediate changes in pressure pain threshold at the exercising muscle (quadriceps) and a non-exercising muscle (upper trapezius) during low and high weight knee extension exercise. Participants will attend one session that consists of pain sensitivity testing, completion of pain-related psychological questionnaires, and random assignment to one of three interventions: 1) knee extension exercise with a high weight, 2) knee extension exercise with a low weight, or 3) quiet rest.

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 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

September 27, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 30, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

October 31, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 27, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 27, 2023

Completed
1.7 years until next milestone

Results Posted

Study results publicly available

December 9, 2024

Completed
Last Updated

December 9, 2024

Status Verified

October 1, 2024

Enrollment Period

5 months

First QC Date

September 27, 2022

Results QC Date

May 31, 2024

Last Update Submit

October 30, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    1 day

Secondary Outcomes (1)

  • Conditioned Pain Modulation

    1 day

Study Arms (3)

High Intensity Exercise

EXPERIMENTAL

Participants will complete a knee extension exercise with weight equivalent to 75% of their 1-repetition maximum for 3 sets of 10 repetitions.

Other: Seated knee extension exercise

Low Intensity Exercise

EXPERIMENTAL

Participants will complete a knee extension exercise with weight equivalent to 30% of their 1-repetition maximum for 3 sets of 10 repetitions.

Other: Seated knee extension exercise

Quiet Rest

NO INTERVENTION

Participants will sit quietly for two minutes, three times.

Interventions

Participants will be seated in a resistance exercise machine. Weight corresponding to the assigned group will be added to the machine. Participants will extend the dominant knee for 3 sets of 10 repetitions.

High Intensity ExerciseLow Intensity Exercise

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, 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

Results Point of Contact

Title
Abigail Wilson
Organization
University of Central Florida

Study Officials

  • Abigail Wilson

    University of Central Florida

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

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

Study Record Dates

First Submitted

September 27, 2022

First Posted

September 30, 2022

Study Start

October 31, 2022

Primary Completion

March 27, 2023

Study Completion

March 27, 2023

Last Updated

December 9, 2024

Results First Posted

December 9, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations