Clinical Trial Finder

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

Study Purpose

The objective of the study is to explore the effects of arm exercise (UE, arm ergometer) vs.#46; 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).

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 45 Years - 90 Years
Gender All
More Inclusion & Exclusion 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT06105788
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 University of Texas, El Paso
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Knee Osteoarthritis, Knee Pain Chronic, Central Pain Syndrome
Arms & Interventions

Arms

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;

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.

Interventions

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

The University of Texas at El Paso, El Paso, Texas

Status

Recruiting

Address

The University of Texas at El Paso

El Paso, Texas, 79968

Site Contact

Kosaku Aoyagi, PhD

[email protected]

915-747-8215

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