NCT06105788 Upper and Lower Extremity Exercise and Exercise-Induced Hypoalgesia in Knee Osteoarthritis
| NCT ID | NCT06105788 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Texas, El Paso |
| Condition | Knee Osteoarthritis |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2023-11-15 |
| Primary Completion | 2025-10-16 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2023-11-15 with a primary completion date of 2025-10-16.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The objective of the study is to explore the effects of arm exercise (UE, arm ergometer) vs. leg exercise (LE, cycling ergometer) on exercise-induced hypoalgesia (EIH), central pain mechanisms and knee pain in people with knee osteoarthritis (OA). Furthermore, we will explore relations of socioeconomic status, racial discrimination, acculturative stress, and autonomic function to exercise effects on EIH, central pain mechanisms, and knee pain. This will be a pilot randomized cross-over study where all participants undergo Day 1 (baseline assessments), Day 2 (UE or LE), and Day 3 (UE or LE).
Eligibility Criteria
Participants with knee OA (Target n=40) Inclusion Criteria: We will recruit participants with knee OA, using the National Institute for Health and Care Excellence's clinical diagnostic criteria, which does not require radiographs. The clinical diagnostic criteria include: * age ≥45 * activity-related knee pain * either no morning joint-related stiffness or stiffness that lasts ≤ 30 minutes. * knee pain at least 4 on a 0-10 pain scale * knee pain as a chief complaint if having multiple pain * understand English Exclusion Criteria: * peripheral neuropathy or other sensation loss on the body sites for pain measurements (i.e., the wrist, knee, the forearm) * use of medical devices electrically active (e.g., pacemaker) * chronic use of opioids * pregnant women * serious and uncontrolled concomitant disease, including cardiovascular, nervous system, pulmonary, renal, hepatic, metabolic, hormonal, endocrine, gastrointestinal or epileptic disease * rheumatoid arthritis, ankylosing spondylitis, and any neurological disorders that prevent the study procedure * cognitive impairment * history of a knee replacement surgery * inability to perform exercise due to severe pain or other symptoms * any intervention procedures for knee pain in the last 3 months Inclusion and exclusion criteria for pain-free controls (Target n = 20) Pain-free controls are not having a pain-related medical condition. They have to speak and understand English. Pain-free controls are excluded if they had experienced a pain episode, caused by musculoskeletal injury or otherwise in the previous 3 months.
Contact & Investigator
Kosaku Aoyagi, PhD
PRINCIPAL INVESTIGATOR
Assistant Professor
Frequently Asked Questions
Who can join the NCT06105788 clinical trial?
This trial is open to participants of all sexes, aged 45 Years or older, up to 90 Years, studying Knee Osteoarthritis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06105788 currently recruiting?
Yes, NCT06105788 is actively recruiting participants. Contact the research team at kaoyagi@utep.edu for enrollment information.
Where is the NCT06105788 trial being conducted?
This trial is being conducted at El Paso, United States.
Who is sponsoring the NCT06105788 clinical trial?
NCT06105788 is sponsored by University of Texas, El Paso. The principal investigator is Kosaku Aoyagi, PhD at Assistant Professor. The trial plans to enroll 60 participants.