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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05525403
Other study ID # 2
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 28, 2022
Est. completion date April 20, 2023

Study information

Verified date April 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 compare immediate changes in pain sensitivity (pressure pain threshold) during quiet rest, low fatigue exercise, and high fatigue exercise.


Description:

Participants will attend three sessions. Participants will fill out questionnaires, undergo pain sensitivity testing, and be randomly assigned to complete a high and low fatigue exercise on either the second or third session. During the exercise, participants will complete three sets of a single leg knee extension exercise with weight equivalent to 50% of their 1 repetition maximum until they report either a high or low fatigue level. Immediately before and after each set, the research team will examine immediate changes in sensitivity to pressure (pressure pain threshold).


Recruitment information / eligibility

Status Completed
Enrollment 31
Est. completion date April 20, 2023
Est. primary completion date April 20, 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 (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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Knee Extension Exercise
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.
Quiet Rest
Participants will sit quietly for two minutes, three times.

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
Other 1-repetition maximum testing The amount of weight that can be lifted for 1 repetition Baseline, pre exercise
Primary 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 Temporal Summation Participants will rate a train of 10 heat pulses using the 101-point numerical pain rating scale Baseline, pre exercise
Secondary Heat Pain Threshold A thermode will gradually increase temperature. Participants will state when the sensation first becomes painful. Baseline, pre exercise
Secondary Conditioned Pain Modulation Pressure pain threshold after an ice water immersion task will be measured. Baseline, pre exercise
Secondary International Physical Activity Questionnaire Short Form This is a self-report measure of physical activity that provides data regarding health-related physical activity. Baseline, pre exercise
Secondary Pittsburgh Sleep Quality Index This is a 10-item questionnaire in which individuals respond to statements regarding sleep quality. A higher score indicates a worse sleep quality. Baseline, pre exercise
Secondary Pain Catastrophizing Scale This is a 13-item questionnaire in which individuals respond to a statement on a five point scale from 0 to 4. Higher scores indicate higher pain catastrophizing levels. Baseline, pre exercise
Secondary Fear of Pain Questionnaire 9 This is a 9-item questionnaire in which individuals respond to a statement on a five point scale from 1 to 5. Higher scores indicate higher fear of pain. Baseline, pre exercise
Secondary Pain Anxiety Symptom Scale This is a 20-item questionnaire in which individuals respond to a statement on a six point scale from 0 to 5. Higher scores indicate higher pain-related anxiety. Baseline, pre exercise
Secondary Brief Resilience Scale This is a 6-item questionnaire in which individuals respond to a statement on a five point scale from 1 to 5. Higher scores indicate greater resilience. Baseline, pre exercise
Secondary Preference for and Tolerance of the Intensity of Exercise Questionnaire This is a 16-item questionnaire in which individuals respond to a statement on a five point scale from 1 to 5. Higher scores indicate lower tolerance for the intensity of exercise. Baseline, pre exercise
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