Clinical trial NCT06105788: Upper and Lower Extremity Exercise and Exercise-Induced Hypoalgesia in Knee Osteoarthritis
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Knee Osteoarthritis
Knee Pain Chronic
Central Pain Syndrome
Lead sponsor: University of Texas, El Paso
Sponsor class: OTHER
First posted: 2023-10-30
Enrollment: 60
Sex: ALL
Minimum age (years): 45
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This will be a pilot randomized cross-over study. Once enrolled, all participants will undergo 3 laboratory visits, each separated at least by a week as a wash-out period: day 1, baseline assessment; day 2, randomized to either arm exercise (AE) or leg exercise (LE) ; and day 3, AE or LE alternative to the exercise on day 2.
Primary purpose: TREATMENT

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).

Detailed description: This will be a pilot randomized cross-over study. Major exclusion criteria will be conditions that have risks with exercise or affect pain assessments. Once enrolled, all participants will undergo 3 laboratory visits, each separated at least by a week as a wash-out period: day 1, baseline assessment; day 2, randomized to either upper extremity exercise (UEE) (i.e., arm ergometer) or knee exercise (KE) (i.e., cycling ergometer); and day 3, UEE or KE alternative to the exercise on day 2. UEE will be an arm-ergometer and KE will be a cycle-ergometer in which participants will undergo the first 5 minutes at an intensity of 50% heart rate reserve (HRR)(warm-up period), followed by 20 minutes at 70% HRR. Heart rate will be monitored during the exercise.

On day 1, we will collect participant characteristics data. We will also collect data related to race/ethnicity, racial discrimination, acculturative stress, physical activity level, heart rate variability (HRV) parameters (measures of autonomic function). Further, participants will undergo knee pain assessment with a 20-meter walk, quantitative sensory testing (QST) measures of pressure pain threshold (PPT), temporal summation (TS), and conditioned pain modulation (CPM) as surrogate measures of central pain mechanisms.

On Days 2 and 3 we will collect knee pain, QST, and EIH data before and immediately after the exercise.

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.

Primary outcomes:
measure: Changes in pressure pain thresholds (Measure of exercise-induced hypoalgesia)
timeFrame: Day 1: PPT will be assessed twice. PPT assessment --> 25 minutes of waiting --> PPT assessment; Time frame of Days 2 and 3 will be the same except 25 minutes of waiting time. It will be 25 minutes of exercise (either AE or LE) on Days 2 and 3
measure: Mechanical temporal summation
timeFrame: Day 1: TS will be assessed twice. TS assessment --> 25 minutes of waiting --> TS assessment; Time frame of Days 2 and 3 will be the same except 25 minutes of waiting time. It will be 25 minutes of exercise (either AE or LE) on Days 2 and 3
measure: Conditioned pain modulation
timeFrame: Day 1: CPM will be assessed twice. CPM assessment --> 25 minutes of waiting --> CPM assessment; Time frame of Days 2 and 3 will be the same except 25 minutes of waiting time. It will be 25 minutes of exercise (either AE or LE) on Days 2 and 3
measure: Knee pain
timeFrame: Day 1: knee pain will be assessed twice. Knee pain assessment --> 25 minutes of waiting --> knee pain assessment; Time frame of Days 2 and 3 will be the same except 25 minutes of waiting time. It will be 25 minutes of exercise (either AE or LE) on Days 2
Secondary outcomes:
measure: Racial discrimination
timeFrame: Day 1 after obtaining the informed consent form
measure: Acculturative Stress
timeFrame: Day 1 after obtaining the informed consent form
measure: Autonomic function
timeFrame: Day 1 after obtaining the informed consent form
measure: The Western Ontario McMaster Universities Osteoarthritis Index (WOMAC)
timeFrame: Day 1 after obtaining the informed consent form
measure: Pain catastrophizing scale (PCS)
timeFrame: Day 1 after obtaining the informed consent form
measure: Pittsburgh sleep quality index (PSQI)
timeFrame: Day 1 after obtaining the informed consent form
measure: Hospital anxiety and depression scale (HADS)
timeFrame: Day 1 after obtaining the informed consent form
measure: Physical activity
timeFrame: Day 1 after obtaining the informed consent form
measure: Instrument support
timeFrame: Day 1 after obtaining the informed consent form
measure: Emotional support
timeFrame: Day 1 after obtaining the informed consent form
measure: Positive and negative affect
timeFrame: Day 1 after obtaining the informed consent form
Other outcomes:
Locations:
city: El Paso
country: United States
facility: The University of Texas at El Paso
state: Texas
Study officials:
affiliation: Assistant Professor
name: Kosaku Aoyagi, PhD
role: PRINCIPAL_INVESTIGATOR
References: