Ignite Creation Date:
2024-05-06 @ 8:15 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06311240
Status:
RECRUITING
Last Update Posted:
2024-06-14
First Post:
2024-03-08
Brief Title:
Chronic Pain in Patients in Hemodialysis
Sponsor:
Cardenal Herrera University
Organization:
Cardenal Herrera University
Study Overview
Official Title:
Chronic Pain in Patients With Chronic Kidney Disease in Hemodialysis
Status:
RECRUITING
Status Verified Date:
2024-06
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:
DolERC
Brief Summary:
Pain is one of the most common symptoms among patients with End Stage Renal Disease ESRD and often goes unrecognized or inadequately managed in hemodialysis patients More than 50 of patients undergoing hemodialysis suffer from pain with 75 of them being treated ineffectively due to healthcare professionalsamp39 lack of awareness of this symptom Therefore pain management in this population is a complex and challenging task for healthcare providers The most prevalent pain syndromes in hemodialysis patients include musculoskeletal disorders metabolic neuropathies in addition to typical intradialytic pain
The aim of this study is to assess the presence and characteristics of chronic pain in patients with ESRD undergoing hemodialysis to determine whether it is relevant to include the management of chronic pain in the holistic treatment physical activity nutrition and psychological support already being implemented in various studies for these patients
The aim of this study is to assess the presence and characteristics of chronic pain in patients with ESRD undergoing hemodialysis to determine whether it is relevant to include the management of chronic pain in the holistic treatment physical activity nutrition and psychological support already being implemented in various studies for these patients
Detailed Description:
Chronic Kidney Disease CKD has an estimated prevalence ranging from 134 to 106 across stages 1 to 5 These data indicate that CKD is recognized as a major global health issue with high healthcare costs Its incidence increases with age with individuals over 65 years old comprising 40 of CKD patients Gender differences exist with males being more affected although females exhibit greater frailty and severity This population often presents high comorbidity with other conditions such as diabetes hypertension and cardiovascular diseases along with malnutrition sedentary lifestyles poor health-related quality of life low functional capacity frailty high levels of dependency and recently evidenced pain All of these factors are associated with increased mortality risk exceeding 15 annually Cardiovascular disease is the leading cause of death in patients with advanced CKD and a significant risk factor for peripheral arterial disease and lower limb amputation
Chronic pain imposes a significant personal and economic burden affecting over 30 of people worldwide Unlike acute pain which serves a protective function chronic pain may be better considered as a disease itself with both physical and psychological implications There has been a growing acceptance of the biopsychosocial model in addressing patients with chronic pain understanding pain as amp34an unpleasant sensory and emotional experience associated with actual or potential tissue damage or described in terms of such damageamp34 according to the International Association for the Study of Pain IASP This perspective considers pain not only as a purely nociceptive experience but also as a personal experience involving both biological and emotionalpsychological components
Pain is one of the most common symptoms among patients with end-stage CKD often going unrecognized or inadequately managed Barriers to proper pain management include limited awareness of the problem inadequate medical education and common misconceptions about the inevitability of pain in older adults and HD patients More than 50 of hemodialysis patients suffer from pain with 75 of them receiving ineffective treatment due to healthcare professionalsamp39 lack of awareness of this symptom Therefore pain management in this population is a complex and challenging task The most prevalent pain syndromes in hemodialysis patients include musculoskeletal disorders metabolic neuropathies and typical intradialytic puncture pain
Patients with chronic pain from musculoskeletal disorders have been shown to exhibit high levels of catastrophizing fear of movement anxiety depression sleep disturbances and elevated salivary cortisol levels due to the stress caused by chronic pain and the prevalence of musculoskeletal disorders as potential causes of pain in CKD patients
Hormonal alterations at the hypothalamic-pituitary axis HPA level are frequently observed with worsening renal function Traditionally these alterations have been understood as a consequence of renal insufficiency However recent evidence suggests the involvement of such hormonal disorders in the genesis of CKD The HPA axis controls stress responses through a negative feedback mechanism If chronic pain is considered a stressor a reciprocal response is triggered with increased pain activating physiological mechanisms responding to stress such as elevated cortisol thereby increasing perceived pain Chronic pain induces a chronic increase in cortisol and other central mediators of the HPA axis Cortisol is one of the physiological indices used to quantify stress with salivary cortisol levels reflecting HPA axis activity and quantifiable non-invasively through saliva samples using ELISA methods Currently physiological stress assessment is easily performed by measuring cortisol levels in saliva samples
There is a gap in the literature regarding this topic as it has not been studied whether patients with advanced-stage CKD undergoing hemodialysis present the same characteristics of chronic pain as other pathologies such as musculoskeletal disorders
Methodology Study Type A cross-sectional observational study will be conducted Since no previous studies exist a study with n 20 will be conducted and based on this data the sample size calculation will be performed Randomization and blinding will not be performed and no intervention is planned
Variables
The following measurement variables will be used in this study
Biomarkers
Salivary Cortisol Physiological stress assessment will be performed simply by measuring cortisol levels in a saliva sample and subsequently analyzed using the ELISA method
The following questionnaires will be used to measure health condition variables
Sleep Quality The validated Spanish version of the Pittsburgh Sleep Quality Index will be used
Stress The validated Spanish version of the Perceived Stress Questionnaire will be used
Disease Self-Management The self-efficacy questionnaire will be used
The following questionnaire and physical variable measurement will be used to measure variables related to chronic pain
Chronic Pain Severity Scale The validated Spanish version of the Chronic Pain Severity Scale will be used
Pressure Pain Thresholds PPT This variable is used to assess if the patient presents symptoms compatible with central sensitization Pressure will be applied with an algometer at two bilateral points the second rib and knee Each measured subject will be instructed to say amp39stopamp39 when the pressure sensation becomes the first sensation of pain Each measurement will be repeated three times with 10 seconds of rest between them
The following questionnaire will be used to measure headache-related variables
HIT-6 The validated Spanish version of the Headache Impact Test-6 questionnaire will be used
The following questionnaires will be used to measure behavioral variables
Catastrophizing The validated Spanish version of the Pain Catastrophizing Scale will be used
Anxiety and Depression The validated Spanish version of the Hospital Anxiety and Depression Scale HADS will be used
Chronic pain imposes a significant personal and economic burden affecting over 30 of people worldwide Unlike acute pain which serves a protective function chronic pain may be better considered as a disease itself with both physical and psychological implications There has been a growing acceptance of the biopsychosocial model in addressing patients with chronic pain understanding pain as amp34an unpleasant sensory and emotional experience associated with actual or potential tissue damage or described in terms of such damageamp34 according to the International Association for the Study of Pain IASP This perspective considers pain not only as a purely nociceptive experience but also as a personal experience involving both biological and emotionalpsychological components
Pain is one of the most common symptoms among patients with end-stage CKD often going unrecognized or inadequately managed Barriers to proper pain management include limited awareness of the problem inadequate medical education and common misconceptions about the inevitability of pain in older adults and HD patients More than 50 of hemodialysis patients suffer from pain with 75 of them receiving ineffective treatment due to healthcare professionalsamp39 lack of awareness of this symptom Therefore pain management in this population is a complex and challenging task The most prevalent pain syndromes in hemodialysis patients include musculoskeletal disorders metabolic neuropathies and typical intradialytic puncture pain
Patients with chronic pain from musculoskeletal disorders have been shown to exhibit high levels of catastrophizing fear of movement anxiety depression sleep disturbances and elevated salivary cortisol levels due to the stress caused by chronic pain and the prevalence of musculoskeletal disorders as potential causes of pain in CKD patients
Hormonal alterations at the hypothalamic-pituitary axis HPA level are frequently observed with worsening renal function Traditionally these alterations have been understood as a consequence of renal insufficiency However recent evidence suggests the involvement of such hormonal disorders in the genesis of CKD The HPA axis controls stress responses through a negative feedback mechanism If chronic pain is considered a stressor a reciprocal response is triggered with increased pain activating physiological mechanisms responding to stress such as elevated cortisol thereby increasing perceived pain Chronic pain induces a chronic increase in cortisol and other central mediators of the HPA axis Cortisol is one of the physiological indices used to quantify stress with salivary cortisol levels reflecting HPA axis activity and quantifiable non-invasively through saliva samples using ELISA methods Currently physiological stress assessment is easily performed by measuring cortisol levels in saliva samples
There is a gap in the literature regarding this topic as it has not been studied whether patients with advanced-stage CKD undergoing hemodialysis present the same characteristics of chronic pain as other pathologies such as musculoskeletal disorders
Methodology Study Type A cross-sectional observational study will be conducted Since no previous studies exist a study with n 20 will be conducted and based on this data the sample size calculation will be performed Randomization and blinding will not be performed and no intervention is planned
Variables
The following measurement variables will be used in this study
Biomarkers
Salivary Cortisol Physiological stress assessment will be performed simply by measuring cortisol levels in a saliva sample and subsequently analyzed using the ELISA method
The following questionnaires will be used to measure health condition variables
Sleep Quality The validated Spanish version of the Pittsburgh Sleep Quality Index will be used
Stress The validated Spanish version of the Perceived Stress Questionnaire will be used
Disease Self-Management The self-efficacy questionnaire will be used
The following questionnaire and physical variable measurement will be used to measure variables related to chronic pain
Chronic Pain Severity Scale The validated Spanish version of the Chronic Pain Severity Scale will be used
Pressure Pain Thresholds PPT This variable is used to assess if the patient presents symptoms compatible with central sensitization Pressure will be applied with an algometer at two bilateral points the second rib and knee Each measured subject will be instructed to say amp39stopamp39 when the pressure sensation becomes the first sensation of pain Each measurement will be repeated three times with 10 seconds of rest between them
The following questionnaire will be used to measure headache-related variables
HIT-6 The validated Spanish version of the Headache Impact Test-6 questionnaire will be used
The following questionnaires will be used to measure behavioral variables
Catastrophizing The validated Spanish version of the Pain Catastrophizing Scale will be used
Anxiety and Depression The validated Spanish version of the Hospital Anxiety and Depression Scale HADS will be used
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