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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06073899
Other study ID # 7
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 16, 2024
Est. completion date September 1, 2025

Study information

Verified date January 2024
Source University of Central Florida
Contact Abigail Wilson
Phone 4078231026
Email Abigail.Wilson@ucf.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this research is to examine changes in pain sensitivity during high fatigue exercise, low fatigue exercise, and no treatment in individuals who are currently experiencing knee pain. Dosing dynamic resistance exercise intensity based on fatigue level is a novel, clinically feasible method. Dynamic resistance exercise at a high intensity (75% 1 repetition maximum (RM)) produces significant hypoalgesia at local sites compared to no treatment; however, dosing intensity based on 1RM can be challenging to implement in the clinical setting. Fatiguing endurance tasks produce local and systemic reductions in pressure pain threshold with low intensity isometric exercise completed until failure resulting in the largest exercise induced hypoalgesia effects. Fatigue may be an important mediator in pain response to exercise.


Recruitment information / eligibility

Status Recruiting
Enrollment 57
Est. completion date September 1, 2025
Est. primary completion date September 1, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria: - Experiencing knee pain symptom intensity rated as 3/10 or higher in the past 24 hours Exclusion Criteria: - non-English speaking - history of knee surgery or fracture within the past 6 months - history of quadriceps tendon rupture - history of a chronic pain condition, such as fibromyalgia - systemic medical conditions that affect sensation, such as uncontrolled diabetes or neurological conditions - blood clotting disorder, such as hemophilia - known presence of cardiovascular, pulmonary, or metabolic disease - current use of tobacco products - contraindication to the application of ice, including blood pressure over 140/90 mmHg, -conditions that cause hives or blood in urine when exposed to cold, and any reductions in blood flow to arms or legs. - not physically ready to exercise without a medical exam as indicated by the Physical Activity Readiness Questionnaire + (PAR-Q+) - pain during active knee range of motion 0-90 degrees (examined during screening) - Pregnant - unable to attend 4 sessions

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Leg Extension Exercise
Participants will perform a concentric quadriceps contraction into terminal knee extension with weight equivalent to 65% of a1-repetition maximum.

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 computerized pressure algometer (AlgoMed, Ramat Yishai, Israel) with a 1 cm diameter rubber tip will be applied at a constant rate. Participants will be instructed to say 'stop' or 'pain' or press a response button connected to the algometer so that stimulus can be terminated when the sensation first changes from pressure to pain (pain threshold). This will be applied to the quadriceps and upper trapezius on the same side as the participant's knee pain. This procedure will be completed two times before and after each set of exercise with the average analyzed. Outcomes are examined during each intervention visit from enrollment to study completion, about 2 years.
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