Axon - Brain Train for Pain
NCT04418362
Anxiety Disorders, Behavior
Northampton, United Kingdom
View Trial DetailsNCT Number: NCT07180407
BACKGROUND: ICU survivors may experience serious psychological, physical and cognitive impairments following ICU admission, collectively termed Post Intensive Care Syndrome (PICS). Persistent pain is an underrecognized component of PICS. Previous research has shown that persistent pain is a profound clinical challenge in ICU survivors, however, research demonstrates conflicting results. Furthermore, no studies have examined the prevalence of persistent pain in ICU survivors in a contemporary Danish ICU setting.
OBJECTIVES: We aim to examine the clinical trajectory, risk factors, and pathophysiology of persistent pain in ICU survivors in Denmark.
DESIGN AND SAMPLE SIZE: The study is designed as a multicenter, prospective, inception cohort study with clinical follow-up. Based on the pre-study sample size calculation, 800 patients will be included. Patients will be contacted by telephone 90 days and 180 days after ICU discharge, and a series of questionnaires regarding pain, sleep quality, affective state and quality of life will be completed. A subgroup of patients will undergo a detailed clinical examination including quantitative sensory testing between 180-365 days after ICU discharge.
POPULATION: Patients will be recruited from 4 Danish ICU departments. Inclusion criteria include adult patients (18 years of age), acute admission to the ICU, and an ICU admission of a minimum of 48 hours.
OUTCOMES: The primary outcome is the prevalence of pain assessed by the Brief Pain Inventory (BPI) at 90 and 180 days after ICU discharge. Secondary outcomes include additional detailed descriptions of pain and daily activity, sleep quality, affective state, quality of life, treatment- and patient-related risk factors, and biomarkers associated with development of persistent pain.
Substudies:
- QST substudy: 80 participants (40 with pain and 40 without pain) recruited from the main cohort will undergo Quantative Somatosensory Testing (QST). The objectives are first, to delineate somatosensory profiles of ICU survivors with and without pain, and second, to examine the presence of neuropathic pain in ICU survivors.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Aalborg University Hospital, Aalborg, Denmark
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 180 day follow-up
Patients are defined as having pain if they answer "yes" to question number 1 in the Brief Pain Inventory - Short Form
Time frame: At follow-up at 90 and 180 days
Additional components of the Brief Pain Invenstory Short Form
Time frame: at 90 and 180 days follow-up
Definition of new-onset persistent pain: Individuals presenting with pain according to Brief Pain Inventory Short Form at 90 AND 180 days follow-up AND not suffering from persistent pain/using pain medication regularly before ICU admission, as reported by the individual.
Time frame: at 90 and 180 days
The EQ-5D-5L comprises 5 components (mobility, self-care, usual activity, pain/discomfort, and anxiety/depression) which can be rated at 5 levels. Furthermore, a Visual Analog Scale (VAS) documents self-rated health
Time frame: at 90 and 180 days
The respondent is asked to rate the overall quality of sleep over a 7-day recall period on a VAS. Respondents are instructed to consider the following components before answering the questionnaire: hours of sleep, night wakings, how easily they fall asleep, how often they wake earlier then needed, and how refreshed they feel when waking. Sleep quality is scored as follows: 0 = terrible, 1-3 = poor, 4-6 = fair, 7-9 = good, and 10 = excellent
Time frame: at 90 and 180 days
It comprises seven questions regarding anxiety and seven questions regarding depressive symptoms. Anxiety and depression are scored separately with recommended cut-off values of 8-10 for possible presence of a mood disorder and >11 for probable presence of a mood disorder
Time frame: 90 and 180 days
Only patients answering "yes" to the Brief Pain Inventory Short Form, question number 1, will be asked to fill out the S-LANSS. The tool was created as a clinical tool to identify pain primarily of neuropathic origin, allowing for the differentiation between neuropathic pain and nociceptive pain. It contains 7 items assessing pain quality, sensory changes and specific symptoms commonly associated with neuropathic pain. A score above 12 suggests neuropathic pain
Time frame: 30 days
Time frame: 90 days
Time frame: 180 days
Time frame: between 180 days followup and 360 days.
QST SUBSTUDY: This test includes a series of tasks designed to examine physical performance. The SPPB requires limited space and takes about 10 minutes to complete. It contains 3 domains (3 m gait speed, 5 times chair stands, and 3 progressive standing balance tasks). Each component is scored separately, and a total score is calculated. The maximum score is 12 indicating little to no mobility impairment
Time frame: between 180 days followup and 360 days
QST SUBSTUDY: The questionnaire assesses pain intensity (three questions), pain course patterns, the location of pain and presence of radiating pain (via a body chart), and sensory descriptors of pain (seven questions). Scores of 0-12 indicate neuropathic pain component is unlikely, scores of 12-18 indicates results are ambiguous, however a neuropathic component can pe present, and lastly scores of 19-38 indicates neuropathic pain component is likely
Time frame: between 180 days followup and 360 days
QST SUBSTUDY:
Time frame: between 180 days followup and 360 days
QST SUBSTUDY:
Time frame: between 180 days followup and 360 days
QST SUBSTUDY:
Time frame: between 180 days followup and 360 days
QST SUBSTUDY:
Time frame: between 180 days followup and 360 days
QST SUBSTUDY:
Contact information is provided by the study sponsor or research team.
Zealand University Hospital
Other
The Post-ICU Pain Study: a Multicenter, Prospective, Inception Cohort Study
Acronym: PIP
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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