Chronic Pain in Patients in Hemodialysis (DolERC)

June 12, 2024 updated by: Eva Segura Ortí, Cardenal Herrera University

Chronic Pain in Patients With Chronic Kidney Disease in Hemodialysis

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 professionals' 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.

Study Overview

Status

Recruiting

Conditions

Detailed Description

Chronic Kidney Disease (CKD) has an estimated prevalence ranging from 13.4% to 10.6% 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 "an unpleasant sensory and emotional experience associated with actual or potential tissue damage, or described in terms of such damage," 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 emotional/psychological 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 professionals' 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 'stop' 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 Type

Observational

Enrollment (Estimated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Eva F Segura-Ortí, PhD
  • Phone Number: 64439 00034961369000
  • Email: ESEGURA@UCHCEU.ES

Study Contact Backup

Study Locations

  • Spain
    • Barcelona
      • Terrassa, Barcelona, Spain, 08227
        • Recruiting
        • Consorci Sanitari de Terrassa
        • Contact:
          • Vicent Esteve-Simó, PhD
          • Phone Number: 00 34 937310007
          • Email: vesteve@cst.cat
    • Valencia
      • Alfara del Patriarca, Valencia, Spain, 46115
        • Not yet recruiting
        • Universidad Cardenal Herrera-CEU, CEU Universities
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients selected by Nephrologists in different Hemodialysis units collaborating in the current project, which includes holistic treatment through non-immersive virtual reality both at the dialysis center and at home, will be invited to participate in this study. Patients from different Hemodialysis units (Hospital de Manises and with approval from the Clinical Research Ethics Committee (CEIC) at the Consorcio Sanitario de Terrassa) and patients who are part of the renal patient association ALCER España (Association for the Fight against Kidney Diseases) will also be selected.

Description

Inclusion Criteria:

  • Patients with End-Stage Renal Disease (ESRD)
  • Have been on hemodialysis treatment for at least 3 months and are medically stable.
  • Able to walk a few steps, even if they require walking aids such as canes or walkers.

Exclusion Criteria:

  • Myocardial infarction in the past 6 weeks.
  • Unstable angina during exercise or at rest.
  • Amputation of lower limbs above the knee without prosthetics.
  • Cerebrovascular disease such as stroke or transient ischemic attacks in the last 6 months or with significant sequelae affecting lower limb mobility.
  • Musculoskeletal or respiratory disorders that worsen with exercise.
  • Inability to perform study tests/questionnaires.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Participant with CKD
Participant with CKD answering the questionnaires

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stress level assessed by the salivary cortisol test
Time Frame: Baseline
Higher stress present higher cortisol levels
Baseline
Stress level assessed by the perceived stress scale (PSS)
Time Frame: Baseline
The minimal score is 0. The maximum PSS score is 56. The higher score obtained, the higher stress level
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Self- efficacy assessed by questionnaire
Time Frame: Baseline
The minimal score is 0. The maximun Self-efficacy score is 40. The lower score obtained , the lower self-efficacy
Baseline
Quality of sleep assessed by Pittsburgh Sleep Quality Index
Time Frame: Baseline
The minimal score is 0. The maximun quality index score is 21. The higher score obtained, the lower quality of sleep
Baseline
The impact of headaches on life assessed by Headache Impact Test-6
Time Frame: Baseline
The minimal score is 0. The maximun Headache Impact Test-6 score is 79. The higher score obtained, the higher impact of headaches on life
Baseline
Anxiety and depression assessed by Hospital anxiety and depression scale (HADS)
Time Frame: Baseline
The minimal score is 0. The cutoff point for the two subscales, anxiety and depression, is 8 and < 10. The higher score obtained, The higher impact of anxiety and depression levels on life.
Baseline
Aspects of catastrophic cognitions about pain-rumination, magnification, and helplessness assessed by The Pain Catastrophizing Scale (PCS)
Time Frame: Baseline
The minimal score is 0. The maximun The Pain Catastrophizing Scale score is 52. The higher score obtained, the higher impact of pain rumination, magnification and helplessness on life related to pain.
Baseline
Chronic pain assessed by Chronic Pain Grade Questionnaire
Time Frame: Baseline
The minimal score is 0. The maximun Chronic Pain Grade Questionnaire score is 70. The higher score obtained, the higher impact of chronic pain on life
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cardenal Herrera University

Collaborators

Consorci Sanitari de Terrassa

Investigators

  • Principal Investigator: Miriam Garrigós-Pedrón, PhD, Universidad Cardenal Herrera-CEU, CEU Universities

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 2, 2024

Primary Completion (Estimated)

June 1, 2024

Study Completion (Estimated)

September 1, 2024

Study Registration Dates

First Submitted

March 8, 2024

First Submitted That Met QC Criteria

March 8, 2024

First Posted (Actual)

March 15, 2024

Study Record Updates

Last Update Posted (Actual)

June 14, 2024

Last Update Submitted That Met QC Criteria

June 12, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 02-24-108-003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Data will be shared under request

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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