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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05561582
Other study ID # 3
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 31, 2022
Est. completion date March 27, 2023

Study information

Verified date March 2023
Source University of Central Florida
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date March 27, 2023
Est. primary completion date March 27, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria: - Pain-free - 18-60 years old - Participant can appropriately perform the knee extension exercise (assessed during screening) Exclusion Criteria: - 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Seated knee extension exercise
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.

Locations

Country Name City State
United States University of Central Florida Orlando Florida

Sponsors (1)

Lead Sponsor Collaborator
University of Central Florida

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 to immediately after the exercise
Secondary Conditioned Pain Modulation Pressure pain threshold after an cold water immersion task will be measured. Change from baseline to immediately after the exercise.
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