Knee OsteoarthritisNCT06105788
Upper and Lower Extremity Exercise and Exercise-Induced Hypoalgesia in Knee Osteoarthritis
A study testing Exercise in people with Knee Osteoarthritis and Knee Pain Chronic, run by University of Texas, El Paso at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 45 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Knee Osteoarthritis, Knee Pain Chronic, Central Pain Syndrome
- What is being tested?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Nov 2023to 16 Oct 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The University of Texas at El Paso
El Paso, Texas, 79968
Kosaku Aoyagi, PhD, 915-747-8215, kaoyagi@utep.edu
About this study
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
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).
Read the 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.
- Being tested
- Exercise
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
Also called Arm exercise, Leg 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.
| Study group | Role | What they receive |
|---|---|---|
| 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; Receives: 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. Receives: Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
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.
Measured: Day 1 after obtaining the informed consent form
Acculturative Stress
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.
Measured: Day 1 after obtaining the informed consent form
Autonomic function
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.
Measured: Day 1 after obtaining the informed consent form
The Western Ontario McMaster Universities Osteoarthritis Index (WOMAC)
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.
Measured: Day 1 after obtaining the informed consent form
Pain catastrophizing scale (PCS)
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.
Measured: Day 1 after obtaining the informed consent form
Pittsburgh sleep quality index (PSQI)
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.
Measured: Day 1 after obtaining the informed consent form
Hospital anxiety and depression scale (HADS)
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.
Measured: Day 1 after obtaining the informed consent form
Physical activity
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.
Measured: Day 1 after obtaining the informed consent form
Instrument support
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.
Measured: Day 1 after obtaining the informed consent form
Emotional support
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.
Measured: Day 1 after obtaining the informed consent form
Positive and negative affect
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
Measured: Day 1 after obtaining the informed consent form
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2023
- Study start15 Nov 2023
- Primary completion16 Oct 2025 (estimated)
- Study completion16 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Texas, El Paso
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kosaku Aoyagi, PhD, Principal investigator, Assistant Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06105788
- Sponsor's protocol ID
- 2111266
- Status last verified
- Dec 2024
- First submitted
- 23 Oct 2023
- Last updated
- 16 Dec 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06105788
- Acronym / sponsor ID
- 2111266
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of Texas, El PasoUniversity, hospital or other
- Study start
- 15 Nov 2023 (actual)
- Primary completion
- 16 Oct 2025 (estimated)
- Study completion
- 16 Oct 2025 (estimated)
- First posted
- 30 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Exercise | Experimental | Other: ExerciseArm 1: All participants, knee OA and pain-free individuals, will undergo a single exercise of arm exercise using an arm ergometer and; |
| Lower Body Exercise | Active comparator | Other: ExerciseArm 2: All participants, knee OA and pain-free individuals, will undergo a single exercise of leg exercise using a cycling ergometer. |
Who may qualify
- Ages
- 45 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExerciseAlso: Arm exercise, Leg exerciseArm 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 | Exercise, Lower Body Exercise |
Primary outcome
Changes in pressure pain thresholds (Measure of exercise-induced hypoalgesia)
Time frame: 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.
Mechanical temporal summation
Time frame: 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.
Conditioned pain modulation
Time frame: 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.
Knee pain
Time frame: 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.
11 secondary outcomes
Racial discrimination
Time frame: Day 1 after obtaining the informed consent form
Acculturative Stress
Time frame: Day 1 after obtaining the informed consent form
Autonomic function
Time frame: Day 1 after obtaining the informed consent form
The Western Ontario McMaster Universities Osteoarthritis Index (WOMAC)
Time frame: Day 1 after obtaining the informed consent form
Pain catastrophizing scale (PCS)
Time frame: Day 1 after obtaining the informed consent form
Pittsburgh sleep quality index (PSQI)
Time frame: Day 1 after obtaining the informed consent form
Hospital anxiety and depression scale (HADS)
Time frame: Day 1 after obtaining the informed consent form
Physical activity
Time frame: Day 1 after obtaining the informed consent form
Instrument support
Time frame: Day 1 after obtaining the informed consent form
Emotional support
Time frame: Day 1 after obtaining the informed consent form
Positive and negative affect
Time frame: Day 1 after obtaining the informed consent form
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kosaku Aoyagi, PhD principal investigator
Assistant Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Knee Osteoarthritis and Knee Pain Chronic, run by University of Texas, El Paso at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kosaku Aoyagi, PhD (9157478215, kaoyagi@utep.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in pressure pain thresholds (Measure of exercise-induced hypoalgesia) (time frame: 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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2024; AzTrials last refreshed its copy on 26 Oct 2026.