Effects of Ischemic Preconditioning on Conditioned Pain Modulation and Heart Rate Variability in … (NCT05059652) | Clinical Trial Compass
CompletedNot Applicable
Effects of Ischemic Preconditioning on Conditioned Pain Modulation and Heart Rate Variability in Knee Osteoarthritis
Brazil44 participantsStarted 2023-08-15
Plain-language summary
Introduction: Musculoskeletal disorders have affected approximately 1.3 billion people worldwide. Evidence shows that chronic diseases and musculoskeletal conditions often occur together, and among them it is estimated that more than 240 million people worldwide have symptomatic osteoarthritis (OA) and activity limitation, which is a major contributor to chronic pain and changes central in pain processing. It is known that physical exercise (active approach to treatment) and manual therapy (passive approach) are capable of intervening in the pain processing system, but passive approaches have been little investigated. Among them, little is known about the effect of ischemic preconditioning (IPC) for pain management and its impact on conditioned pain modulation (CPM) and cardiac autonomic control. There is no evidence that IPC causes systemic hypoalgesia and increased vagal modulation, so this provides a rationale for study. Objectives: To analyze the acute effect of IPC on local pain, CPM and cardiac autonomic control in women with knee OA and observe whether there is a correlation between them. Methods: Double-blind, placebo-controlled, randomized clinical trial. Participants will be divided into IPC or placebo groups. Outcomes evaluated: CPM and cardiac autonomic modulation. Comparisons will be performed using Generalized Mixed Linear Models fitted to the data. For correlation, the Pearson or Spearman correlation test will be used according to the normality of the data. All analyzes will assume a significance level of p\<0.05.
Who can participate
Age range
45 Years – 80 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Medical diagnosis for uni or bilateral OA of the tibiofemoral joint (grade II or superior Kellgren-Lawrence radiographic changes);
* Not having systemic rheumatic diseases such as fibromyalgia, rheumatoid arthritis, systemic lupus erythematosus;
* Not having total knee arthroplasty, knee ligament injury, history of knee surgery;
* Not having heart disease, congestive heart failure, or a history of acute myocardial infarction (except those with hypertension);
* Not having diagnosis of neurological, metabolic, endocrine disorder, respiratory disease;
* Not being an alcoholic or smoker;
* Not use drugs that influence cardiac autonomic modulation (beta-blocker);
* Not having one or more predisposing risk factors for thromboembolism.
Exclusion Criteria:
* Use anti-inflammatory drugs or analgesics 24 hours before the test;
* Perform physical activity;
* Consume alcohol;
* Perform therapeutic treatments for pain relief;
* Errors in capturing the RR intervals;
* Want to leave the study.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Conditioned Pain Modulation
Timeframe: Change from baseline after intervention.
2
Cardiac Autonomic Modulation
Timeframe: Change from baseline after intervention.