Ignite Creation Date:
2024-05-06 @ 4:40 PM
Last Modification Date:
2024-10-26 @ 2:14 PM
Study NCT ID:
NCT05059652
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-04-04
First Post:
2021-08-30
Brief Title:
Effects of Ischemic Preconditioning on Conditioned Pain Modulation and Heart Rate Variability in Knee Osteoarthritis
Sponsor:
Paulista University
Organization:
Paulista University
Study Overview
Official Title:
Effects of Ischemic Preconditioning on Conditioned Pain Modulation and Heart Rate Variability in Women With Knee Osteoarthritis Placebo-Controlled Randomized Clinical Trial
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Introduction Musculoskeletal disorders have affected approximately 13 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 p005
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None