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

Sponsor
University of Texas, El Paso (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06105788
Collaborator
(none)
60
1
2
23.5
2.6

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Other: Exercise
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
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.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.
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Anticipated Study Start Date :
Nov 1, 2023
Anticipated Primary Completion Date :
Oct 16, 2025
Anticipated Study Completion Date :
Oct 16, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Exercise

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
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.
Other Names:
  • Arm exercise
  • Leg exercise
  • Active Comparator: Lower Body Exercise

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

    Other: Exercise
    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.
    Other Names:
  • Arm exercise
  • Leg exercise
  • Outcome Measures

    Primary Outcome Measures

    1. Changes in pressure pain thresholds (Measure of exercise-induced hypoalgesia) [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]

      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.

    2. Mechanical temporal summation [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]

      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.

    3. Conditioned pain modulation [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]

      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.

    4. 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]

      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.

    Secondary Outcome Measures

    1. Racial discrimination [Day 1 after obtaining the informed consent form]

      Racial discrimination will be assessed with the Perceived Experiences of Discrimination Questionnaire-Community Version (PEDQ-CV). This is a reliable and valid 17-item survey that assesses experiences of racialized discrimination.

    2. Acculturative Stress [Day 1 after obtaining the informed consent form]

      Acculturative stress will be assessed with The Social, Attitudinal, Familial, Environment Acculturative Stress Scale (SAFE). SAFE is composed of 24 items that measure stress as a result of the acculturation process in four contexts: social, attitudinal, familial and environmental acculturative.

    3. Autonomic function [Day 1 after obtaining the informed consent form]

      Heart rate variability (HRV), a measurement of autonomic function, will be assessed using a wearable and wireless heart rate monitor. Investigators will have participants lie supine for 5 minutes to collect heart rate variability parameters such as high frequency and high-frequency/low-frequency ratio.

    4. The Western Ontario McMaster Universities Osteoarthritis Index (WOMAC) [Day 1 after obtaining the informed consent form]

      WOMAC knee pain scale ranges 0-20 with 5 questions assessing knee pain in different contexts such as knee pain during walking and pain during standing. Each question has a score of 0-4. A greater WOMAC score represents greater knee pain.

    5. Pain catastrophizing scale (PCS) [Day 1 after obtaining the informed consent form]

      The Pain Catastrophizing Scale is a validated 13-item scale with questions related to catastrophizing behavior. The total score is 52 with higher scores indicating greater catastrophic thoughts.

    6. Pittsburgh sleep quality index (PSQI) [Day 1 after obtaining the informed consent form]

      The Pittsburgh Sleep Quality Index (PSQI) is a self-reported questionnaire. PSQI contains 19 individual items, creating seven components that produce one global score, ranging from 0 to 21. A score of 0-4 indicates the absence of sleep problems, while scores 5 and higher indicate poor sleep quality.

    7. Hospital anxiety and depression scale (HADS) [Day 1 after obtaining the informed consent form]

      HADS contains seven questions about anxiety and seven questions about depression, with a 0-3 score for each question. Higher scores indicate greater anxiety and depression.

    8. Physical activity [Day 1 after obtaining the informed consent form]

      Physical activity will be assessed with International Physical Activity Questionnaire (IPAQ). IPAQ is a 27-item self-reported measure of physical activity. Results can be reported in categorical (low activity levels, moderate activity levels or high activity levels) or as a continuous variable (MET minutes a week). MET minutes represent the amount of energy expended carrying out physical activity.

    9. Instrument support [Day 1 after obtaining the informed consent form]

      Instrument support will be assessed with the PROMIS SFv2.0 Instrumental Support 6a questionnaire. This is a 6-item questionnaire with a 5-point Likert scale ranging from "never" to "Always". Each score will be standardized to T-scores with mean of 50 standard deviation of 10. A higher score indicates having more support.

    10. Emotional support [Day 1 after obtaining the informed consent form]

      Emotional support will be assessed with the PROMIS SFv2.0 Emotional Support 6a questionnaire. This is a 6-item questionnaire with a 5-point Likert scale ranging from "never" to "Always". Each score will be standardized to T-scores with mean of 50 standard deviation of 10. A higher score indicates having more support.

    11. Positive and negative affect [Day 1 after obtaining the informed consent form]

      The Positive and Negative Affect Schedule (PANAS) is a 20-item measure that consists of 10 positive items (e.g., excited, proud) and 10 negative items (e.g., distressed, scared). Items are self-rated on a 5-point Likert-type scale ranging from 1 (very slightly or not at all) to 5 (extremely) and summed to produce total subscale scores for positive and negative affect ranging from 10 to 50, with higher scores representing higher levels of each subscale

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    45 Years to 90 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes

    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 The University of Texas at El Paso El Paso Texas United States 79968

    Sponsors and Collaborators

    • University of Texas, El Paso

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Texas, El Paso
    ClinicalTrials.gov Identifier:
    NCT06105788
    Other Study ID Numbers:
    • 2111266
    First Posted:
    Oct 30, 2023
    Last Update Posted:
    Oct 30, 2023
    Last Verified:
    Oct 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 30, 2023