What this study is
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).
What's being tested
- Exercise
Intervention · OTHER
Arm exercise will be an arm ergometer for 20 minutes, preceded by a 5-minute warm-up. Leg exercise will be a cycling ergometer for 20 minutes, preceded by a 5-minute warm-up. The exercise intensity will be set at 70% of the heart rate reserve (HRR) for each type of exercise.
Study details
- Official title
- Comparing Effects of Upper Extremity Versus Lower Extremity Exercise on Exercise-Induced Hypoalgesia in People With Knee Osteoarthritis: A Pilot Cross-over Study
- Sponsor
- University of Texas, El Paso
- Conditions
- Knee Osteoarthritis · Knee Pain Chronic · Central Pain Syndrome
- Enrolling
- 60 people
- Starts
- 2023-11-15
- Est. completion
- 2025-10-16
- Design
- Open-label, randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 45 Years – 90 YearsSex ALLHealthy volunteers AcceptedYou may qualify if
- Participants with knee OA (Target n=40)
- 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
You can't join if
- 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.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openThe University of Texas at El Paso
El Paso, Texas, United States
- Kosaku Aoyagi, PhD · Contact915-747-8215kaoyagi@utep.edu
Recruiting
Study team
Sponsor
University of Texas, El Paso
Study ID 2111266
Principal investigator
Kosaku Aoyagi, PhD
Assistant Professor
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.