Effects of Ischemic Preconditioning on Conditioned Pain Modulation and Heart Rate Variability in Knee Osteoarthritis

NCT ID: NCT05059652

Last Updated: 2025-05-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-15
• Study Completion Date: 2024-12-15

Brief 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.

Conditions

Ischemic Preconditioning

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Ischemic Preconditioning (n= 22)

The IPC protocol will be applied in the proximal region of the thigh of the limb with knee osteoarthritis and if both knees are affected, it will be applied to the knee with the greatest complaint of pain.

Participants will be relaxed and comfortably seated. The same cuff used to determine the total occlusion pressure (TOP) will be used and the protocol will consist of four cycles of total ischemia (according to the TOP value determined individually) of five minutes, followed immediately by four cycles of five minutes of vascular reperfusion (0 mmHg ), totaling 40 minutes.

Group Type: EXPERIMENTAL

Ischemic Preconditioning

Intervention Type: DEVICE

The Ischemic Preconditioning (IPC) is characterized by the application of brief periods of circulatory occlusion (ischemia) and reperfusion of a limb in the minutes to hours that precede the exercise through the insufflations and deflations of a pressure cuff.

Placebo (n= 22)

The placebo protocol will be performed on the lower limb with knee osteoarthritis and if both knees are affected, it will be applied to the knee with the greatest complaint of pain. Participants will perform a protocol similar to the IPC, but during the four cycles of five minutes of occlusion, the cuffs will only be inflated with 10mmHg so as not to cause arterial or venous occlusion, alternating with four cycles of five minutes of reperfusion (0 mmHg).

Group Type: PLACEBO_COMPARATOR

Ischemic Preconditioning

Intervention Type: DEVICE

The Ischemic Preconditioning (IPC) is characterized by the application of brief periods of circulatory occlusion (ischemia) and reperfusion of a limb in the minutes to hours that precede the exercise through the insufflations and deflations of a pressure cuff.

Interventions

Ischemic Preconditioning

The Ischemic Preconditioning (IPC) is characterized by the application of brief periods of circulatory occlusion (ischemia) and reperfusion of a limb in the minutes to hours that precede the exercise through the insufflations and deflations of a pressure cuff.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Paulista University

OTHER

Sponsor Role: lead

Responsible Party

Franciele Marques Vanderle

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Franciele Marques Vanderlei

Presidente Prudente, São Paulo, Brazil

Countries

Brazil

References

Biral TM, de Souza Cavina AP, Junior EP, Filho CATT, Vanderlei FM. Effects of remote ischemic conditioning on conditioned pain modulation and cardiac autonomic modulation in women with knee osteoarthritis: placebo-controlled randomized clinical trial protocol. Trials. 2023 Aug 7;24(1):502. doi: 10.1186/s13063-023-07527-2.

Reference Type: DERIVED

PMID: 37550703 (View on PubMed)

Other Identifiers

5543/2021

Identifier Type: -

Identifier Source: org_study_id