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Pathway for Pain (PIUO Trial)

N/A

Waitlist Available

Led By Hal Siden, MD

Research Sponsored by University of British Columbia

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up end of pathway (up to 8 months post-baseline)

Awards & highlights

PIUO Trial Summary

This trial is for a new systematic approach to managing pain and irritability in children with severe brain-based developmental disabilities, called the PIUO Pathway. The goals are to reduce pain symptoms and improve the child and family's quality of life.

Eligible Conditions

Pain
Neuropathic Pain
Irritability

PIUO Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ end of pathway (up to 8 months post-baseline)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~end of pathway (up to 8 months post-baseline)

This trial's timeline: 3 weeks for screening, Varies for treatment, and end of pathway (up to 8 months post-baseline) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Reduction of pain severity of children on the pathway

Secondary outcome measures

Benefit ranking of ongoing communication with study research nurse

Decreased pain & irritability scores for children over time

Identification of causes of pain and irritability of unknown origin in non-verbal children

+2 more

PIUO Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: PathwayExperimental Treatment1 Intervention

The PIUO Pathway is implemented by clinicians (MD and RN) with expertise in treating pain in children. Each participant proceeds through the PIUO Pathway as long as their pain persists, but will exit the PIUO Pathway at any stage in case their pain is resolved. The Pathway has two steps: Step 1 is a thorough history and patient evaluation, including directed testing. Step 2 is a series of screening tests to further explore any potential underlying disease or injury not apparent based on history and physical examination.

Group II: WaitlistActive Control1 Intervention

Participants randomized to the Waitlist will cross over to the Pathway after 8 weeks.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

The Hospital for Sick ChildrenOTHER

691 Previous Clinical Trials

6,945,494 Total Patients Enrolled

22 Trials studying Pain

6,781 Patients Enrolled for Pain

University of British ColumbiaLead Sponsor

1,418 Previous Clinical Trials

2,466,998 Total Patients Enrolled

16 Trials studying Pain

2,263 Patients Enrolled for Pain

Canadian Institutes of Health Research (CIHR)OTHER_GOV

1,345 Previous Clinical Trials

26,453,394 Total Patients Enrolled

11 Trials studying Pain

2,021 Patients Enrolled for Pain

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there current opportunities to participate in this experimental research?

"Results on clinicaltrials.gov show that the trial is not presently enrolling patients, with its original posting being published in April of 2018 and most recent update occurring in October 2021. Fortunately, there are 501 other studies actively seeking participants at this time."

Answered by AI

Does this research endeavor allow those who are younger than seventy years old to participate?

"The parameters for this trial require that participants are aged between 6 months and 18 years old. There are 84 clinical trials available to minors, while elderly individuals (over 65) have 383 studies they can participate in."

Answered by AI

To what population is this clinical trial open?

"This clinical trial is presently recruiting 120 minors, aged 6 months to 18 years, who have pain but cannot be accurately evaluated due to cognitive or communication impairments. To qualify for enrolment in this study, children must present scores of 3 or greater on two scales assessing the persistence and distress level of their symptoms as well as demonstrate a type of Pain and Irritability with Unexplained Onset (PIUO) with no visible cause. Furthermore, they need to fall under Gross Motor Functional Classification System (GMFCS) levels 3-5 in terms of disability severity."

Answered by AI

Recent research and studies

Pain Research and ManagementJournal

Physician Variability in Treating Pain and Irritability of Unknown Origin in Children with Severe Neurological Impairment

Siden, Harold B, Bruce C Carleton, and Tim F Oberlander. 2013. “Physician Variability in Treating Pain and Irritability of Unknown Origin in Children with Severe Neurological Impairment”. Pain Research and Management. Hindawi Limited. doi:10.1155/2013/193937.

clinicaltrials.govStudy

Pain and Irritability in Non-Verbal Children

Harold Siden 2018. "Pain and Irritability in Non-Verbal Children". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03464773.