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

Primary Purpose

Ischemic Preconditioning

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Ischemic Preconditioning
Sponsored by
Paulista University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ischemic Preconditioning focused on measuring ischemic preconditioning, therapeutic occlusion, conditioned pain modulation, heart rate variability, autonomic nervous system, osteoarthritis, chronic pain

Eligibility Criteria

45 Years - 80 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Ischemic Preconditioning (n= 22)

    Placebo (n= 22)

    Arm Description

    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.

    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).

    Outcomes

    Primary Outcome Measures

    Conditioned Pain Modulation
    Conditioned pain modulation is a dynamic measure capable of evaluating endogenous pain inhibition using a "pain-by-pain inhibition" model in which pain in a local area (test stimulus) is inhibited by a second concomitant pain (pain stimulus) conditioning). In this study, the test stimulus will be performed through the pressure pain threshold using algometer and the conditioning stimulus will be performed by immersing the hand in cold water, using the cold pressor test - CPT.
    Cardiac Autonomic Modulation
    The assessment of cardiac autonomic modulation will be performed using HRV through the capture of heart rate beat to beat (RR intervals) using a heart rate monitor (Polar Electro Oy, Kempele, Finland - model V800) which is a validated equipment.

    Secondary Outcome Measures

    Full Information

    First Posted
    August 30, 2021
    Last Updated
    March 28, 2023
    Sponsor
    Paulista University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05059652
    Brief Title
    Effects of Ischemic Preconditioning on Conditioned Pain Modulation and Heart Rate Variability in Knee Osteoarthritis
    Official Title
    Effects of Ischemic Preconditioning on Conditioned Pain Modulation and Heart Rate Variability in Women With Knee Osteoarthritis: Placebo-Controlled Randomized Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    August 2023 (Anticipated)
    Primary Completion Date
    December 2023 (Anticipated)
    Study Completion Date
    July 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Paulista University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Ischemic Preconditioning
    Keywords
    ischemic preconditioning, therapeutic occlusion, conditioned pain modulation, heart rate variability, autonomic nervous system, osteoarthritis, chronic pain

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Masking Description
    Double
    Allocation
    Randomized
    Enrollment
    44 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Ischemic Preconditioning (n= 22)
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Placebo (n= 22)
    Arm Type
    Placebo Comparator
    Arm Description
    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).
    Intervention Type
    Device
    Intervention Name(s)
    Ischemic Preconditioning
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Conditioned Pain Modulation
    Description
    Conditioned pain modulation is a dynamic measure capable of evaluating endogenous pain inhibition using a "pain-by-pain inhibition" model in which pain in a local area (test stimulus) is inhibited by a second concomitant pain (pain stimulus) conditioning). In this study, the test stimulus will be performed through the pressure pain threshold using algometer and the conditioning stimulus will be performed by immersing the hand in cold water, using the cold pressor test - CPT.
    Time Frame
    Change from baseline after intervention.
    Title
    Cardiac Autonomic Modulation
    Description
    The assessment of cardiac autonomic modulation will be performed using HRV through the capture of heart rate beat to beat (RR intervals) using a heart rate monitor (Polar Electro Oy, Kempele, Finland - model V800) which is a validated equipment.
    Time Frame
    Change from baseline after intervention.

    10. Eligibility

    Sex
    Female
    Gender Based
    Yes
    Gender Eligibility Description
    Women with knee OA, aged 45 years or less and younger than 80 years.
    Minimum Age & Unit of Time
    45 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Franciele M Vanderlei, PhD
    Phone
    (18)3229-5824
    Email
    franmvanderlei@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Taíse M Biral, Master
    Phone
    18996663537
    Email
    taisemendes_@hotmail.com

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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

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