Biopsychosocial Factors in Resistance Exercise in Individuals With Knee Pain

• Sponsor: University of Central Florida (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT06073899
• Collaborator: (none)
• Enrollment: 57
• Arms: 3
• Anticipated Duration (Months): 22.5

Study Details

Study Description

Brief 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% 1RM) 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 EIH effects. Fatigue may be an important mediator in pain response to exercise.

Condition or Disease	Intervention/Treatment	Phase
Knee Pain	Other: Leg Extension Exercise	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 57 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Single (Investigator)
• Masking Description: Investigator administering Pressure Pain Threshold will be blinded to the intervention.
• Primary Purpose: Treatment
• Official Title: Biopsychosocial Factors in Resistance Exercise in Individuals With Knee Pain
• Anticipated Study Start Date: Oct 16, 2023
• Anticipated Primary Completion Date: Sep 1, 2025
• Anticipated Study Completion Date: Sep 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Quiet Rest Participants will sit quietly for two minutes, three times. Pressure pain threshold will be measured between each two-minute interval.
Experimental: High Fatigue Exercise Participants will perform a leg extension exercise in a machine with weight equipment to 65% of their 1-repetition maximum. Participants will complete this exercise for three sets until they report the exercise is "hard" (8/10 on the OMNI-RES scale).	Other: Leg Extension Exercise; Participants will perform a concentric quadriceps contraction into terminal knee extension with weight equivalent to 65% of a1-repetition maximum.
Active Comparator: Low Fatigue Exercise Participants will perform a leg extension exercise in a machine with weight equipment to 65% of their 1-repetition maximum. Participants will complete this exercise for three sets until they report the exercise is "somewhat easy" (4/10 on the OMNI-RES scale).	Other: Leg Extension Exercise; Participants will perform a concentric quadriceps contraction into terminal knee extension with weight equivalent to 65% of a1-repetition maximum.

Outcome Measures

Primary Outcome Measures

1. Pressure Pain Threshold [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.]

   A computerized pressure algometer (AlgoMed, Ramat Yishai, Israel) with a 1 cm diameter rubber tip will be applied at a constant rate of 1 kPa/s. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• University of Central Florida

Investigators

• Principal Investigator: Abigail Wilson, University of Central Florida

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Central Florida
• ClinicalTrials.gov Identifier: NCT06073899
• Other Study ID Numbers: 7
• First Posted: Oct 10, 2023
• Last Update Posted: Oct 10, 2023
• Last Verified: Sep 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Oct 10, 2023