Fatigue in Chronic Pain - Cognition, Emotional Aspects, Biomarkers, and Neuronal Correlates

NCT05452915 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 72

Last updated 2023-07-13

No results posted yet for this study

Summary

The investigators will examine mental/cognitive as well as cognitive functions (executive functions, attention functions, processing speed, learning and memory) in 200 patients with chronic pain and 36 healthy controls. Mental fatigue will be measured with questionnaires and cognitive fatigue and cognitive functions with neuropsychological tests. As studies on patients with mild traumatic brain injury has shown that fatigue is associated with altered communication (connectivity) in the brain's attention-related networks, brain connectivity will be measure in 24 patients (women only) and 22 healthy female controls using functional magnetic resonance imaging (fMRI) technology. During the fMRI examination, participants will also perform a 20-minute vigilance task in a scanner. Studies have also shown that inflammatory biomarkers may be related to chronic pain, but inflammatory biomarkers has not been studied in relation to objective measures regarding cognition, fatigue and connectivity changes. Therefore, the patients and controls performing fMRI will also be examined with immunological biomarkers. In addition to this, a further 14 patients and 14 controls carrying out the neuropsychological testing alone will also be examined for immunological biomarkers.

The main objectives are:

1. Do patients with chronic pain show more pronounced self-rated mental fatigue and cognitive fatigue compared to healthy controls and are fatigue measures related to cognitive functions such as process speed and attention functions?
2. What is the relationship between cognitive impairments, mental fatigue, or fatigability and

1. the duration of pain
2. generalization of pain and are they affected by covariates, such as sleep disorders and degree of depression/anxiety?
3. Is there an association between immunological biomarkers and cognitive functions/mental fatigue/cognitive fatigability?
4. Does the connectivity in the brain of patients with chronic pain differ from healthy controls at rest as well as during activity while performing a vigilance task?
5. Is there an association between connectivity in the brain and

1. immunological biomarkers
2. fatigability and
3. results on neuropsychological tests?

Conditions

Interventions

DIAGNOSTIC_TEST

Neuropsychological (NPA)

The neuropsychological assessment consists of following tests and questionnaires: * Wechsler Adult Intelligence Scale (WAIS)-III: Digit-Symbol-Coding (Coding) * WAIS-IV: Digit Span, Matrix reasoning * Delis-Kaplan Executive Function Scale (D-KEFS): Color-Word Test, Word Fluency Test * Ruff 2 \& 7 * MapCog Spectra Questionnaires: * EuroQoL five dimensions questionnaire (EQ5D) * Hospital Anxiety and Depression Scale (HADS) * Insomnia Severity Index (ISI) * Multidimensional Fatigue Inventory-20 (MFI-20) * Multidimensional Pain Inventory (MPI) * Screening questions on physical activity * Visual analogue scale on fatigue (VAS-f) before and after NPA * Visual analogue scale on fatigue (VAS-f) and pain before and after the fMRI scanning. * Pain level, experienced during the NPA, will be rated (0-10) at the end of the session

OTHER

Imaging

Imaging (24 patients + 22 controls): BOLD resting-state before and after 20-min vigilance task (e-prime). During the vigilance task, fMRI is performed. Clinical protocol: 1. High-resolution T1-weighted. 2. High-resolution T2-weighted Scan (FLAIR).

DIAGNOSTIC_TEST

Inflammatory biomarkers

Blood samples from inflammatory biomarkers will be taken on 36 patients and 36 controls. Everyone who undergoes imaging will undergo blood tests.

Sponsors & Collaborators

  • University Hospital, Umeå

    collaborator OTHER
  • Karolinska Institutet

    collaborator OTHER
  • Umeå University

    collaborator OTHER
  • Linkoeping University

    collaborator OTHER_GOV
  • Danderyd Hospital

    lead OTHER

Principal Investigators

  • Marika C Möller, PhD · Department of Rehabilitation Medicine, Danderyd Hospital

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-01-01
Primary Completion
2022-12-31
Completion
2022-12-31

Countries

  • Sweden

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05452915 on ClinicalTrials.gov