Upper and Lower Extremity Exercise and Exercise-Induced Hypoalgesia in Knee Osteoarthritis

NCT06105788 | Recruiting

• 1 other identifier: 2111266
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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).

Conditions

Knee Osteoarthritis; Knee Pain Chronic; Central Pain Syndrome

Outcome Measures

Primary Outcomes (4)

• Changes in pressure pain thresholds (Measure of exercise-induced hypoalgesia)

  Pressure pain thresholds (PPT) will be assessed at the wrist and patella. PPT being assessed at a remote body site (e.g., wrist) is to measure central pain sensitivity while PPT being assessed at the location of pain (i.e., knee, patellae) is to assess peripheral pain sensitivity with or without central pain sensitivity. PPT will be assessed using a handheld pressure algometer with 1 cm2 rubber tip. PPT will be defined as the point at which the participant verbally indicated that the pressure first changed to slight pain. A lower PPT value (Kgf) represents greater pain sensitivity. PPT will be assessed 3 times at each location and averaged. Furthermore, changes in PPT after exercise has been used to assess the degree of exercise-induced hypoalgesia (EIH). When PPT values increase after the exercise, it indicates a reduction of pain sensitivity and, therefore, an effect of EIH.

  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

• Mechanical temporal summation

  Temporal summation (TS) is a sensitive measurement of central pain sensitivity. Investigators will assess TS using a standard set of weighted probes from 64-512 mN. Participants will rate the pain experienced by each successive weighted probe being touched on the skin of the wrist until a pain rating of ≥ 4/10 is achieved. The selected probe will be then applied at a frequency of 1 Hz for 10 seconds on the wrist. Participants will provide a pain rating at the completion of the train of 10 stimulations and 15 seconds post-stimulation. TS will be defined as the difference between the highest post-stimulation pain rating and the initial pain rating. A post-stimulation pain rating greater than the initial pain rating will be considered to be reflective of an increase in central pain sensitivity.

  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

• Conditioned pain modulation

  Conditioned pain modulation (CPM) evaluates the adequacy of the descending pain modulatory pathways, which contributes to central pain sensitivity. Investigators will assess CPM using PPT as the test stimulus (PPT1) at the wrist as described above, with forearm ischemia using a blood pressure cuff as the conditioning stimulus. Briefly, the blood pressure cuff applied to the contralateral arm will be inflated to 10mm Hg above systolic pressure. The participant will be then instructed to perform hand grip squeezes until pain of at least 4/10 occurs in the contralateral arm. PPT will be then reassessed at the wrist 3 times and averaged (PPT2). Percent efficiency of CPM (%CPM) was computed as PPT2/PPT1, multiplied by 100; %CPM ≤ 100 indicates inefficient CPM.

  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

• Knee pain

  We will assess changes in knee pain with a 20 meter walk using a 0-10 numeric rating scale where 0 indicates no knee pain and 10 indicates the worst knee pain.

  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 (11)

• Racial discrimination

  Day 1 after obtaining the informed consent form

• Acculturative Stress

  Day 1 after obtaining the informed consent form

• Autonomic function

  Day 1 after obtaining the informed consent form

• The Western Ontario McMaster Universities Osteoarthritis Index (WOMAC)

  Day 1 after obtaining the informed consent form

• Pain catastrophizing scale (PCS)

  Day 1 after obtaining the informed consent form

Study Arms (2)

Exercise

EXPERIMENTAL

Arm 1: All participants, knee OA and pain-free individuals, will undergo a single exercise of arm exercise using an arm ergometer and;

Other: Exercise

Lower Body Exercise

ACTIVE COMPARATOR

Arm 2: All participants, knee OA and pain-free individuals, will undergo a single exercise of leg exercise using a cycling ergometer.

Other: Exercise

Interventions

Exercise 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.

Also known as: Arm exercise, Leg exercise

Exercise; Lower Body Exercise

Eligibility Criteria

• Age: 45 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 may not qualify 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

Sponsors & Collaborators

• University of Texas, El Paso: lead

Study Sites (1)

The University of Texas at El Paso

El Paso, Texas, 79968, United States

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Exercise; Exercise Test

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Ergometry; Investigative Techniques

Study Officials

• Kosaku Aoyagi, PhD

  Assistant Professor

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kosaku Aoyagi, PhD

CONTACT

9157478215; kaoyagi@utep.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 23, 2023
• First Posted: October 30, 2023
• Study Start: November 15, 2023
• Primary Completion: October 16, 2025
• Study Completion: October 16, 2025
• Last Updated: December 16, 2024

Record last verified: 2024-12

Locations

US (1)