Clinical Assessment of Pain Processes in Pediatric Patients With Chronic Musculoskeletal Pain

NCT ID: NCT04308044

Last Updated: 2022-05-04

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 518 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-01-23
• Study Completion Date: 2022-11-30

Brief Summary

Musculoskeletal (MSK) pain is one of the most common types of pain among children and adolescents. Recurring episodes of MSK pain during childhood does not only impact physical and psychological aspects of daily life but may predispose children and adolescents to experience recurrent pain-related illnesses while in adulthood. Thus, effective early life pain management is critical in avoiding a cascade of ill adaptive behaviors. Close to 16,000 children are seen in the clinics of the Shriners Hospital for Children - Canada each year. In the clinic, questionnaires are the standardized clinical way to access the patient's history on pain experience and their perception of it. However, clinicians currently lack the tools to objectively examine pain processes. The ultimate goal of this project is to investigate pain assessment techniques that could be used to phenotype pediatric MSK pain by their endogenous central pain modulation efficacy to provide a more personalized approach to pain management.

Detailed Description

Enabling better pain management in children with musculoskeletal (MSK) pathologies by improving assessment techniques is a cornerstone of this research program.

This research project will elucidate the regulation of specific physiological mechanisms related to pain in children reporting presence of chronic MSK pain. As molecular events of pathophysiological processes are quantifiable, the investigators will test for associations between the expression of pain-related molecular markers in blood and the patient's experience of pain assessed with semi-objective sensory testing. The identification of specific alterations in the nociceptive process will provide a deeper understanding of a patient's pain perception alongside self-report or observers' report subjective measurements. Pain experience variability may originate in the lack of rigor in the clinical pain assessment tools. A personalized mechanism-based approach may be the key to better identify a patient's pain outcome and how this assessment could lead to personalized pain management. By testing temporal summation (TS), conditioned pain modulation (CPM), electroencephalography (EEG) patterns and balance in relation to biomarkers, the investigators will be able to determine the phenotype of the patients who presents higher risk of central sensitization related to increased hyperactivity and decreased endogenous inhibition. The ultimate goal is to use this information to offer the highest quality of pain control in children with MSK conditions.

Conditions

Chronic Pain

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Chronic MSK Pain

Participants who have chronic musculoskeletal pain.The pain profile of the patient will be assessed, including biological sample analysis (blood), quantitative sensory testing, electroencephalogram (EEG), and psychological state via the completion of questionnaires by the patient.

No interventions assigned to this group

Healthy Control

Participants who do not have chronic musculoskeletal pain.The pain profile of the patient will be assessed, including biological sample analysis (blood), quantitative sensory testing, electroencephalogram (EEG), insole assessment (40 healthy control participants), and psychological state via the completion of questionnaires by the patient.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Aged between 10 and 18 years old
• Report of MSK pain lasting 3 months or longer, including orthopaedic diagnoses such as those involving the spine, knees, hips, ankles, shoulders.
• Ability to adequately understand and respond to outcome measures
• Female or male
• Any ethnic background

Exclusion Criteria

• Inability of the child to speak English or French
• Pain due to an acute trauma occurring in the last 3 months (e.g. fracture)
• Diagnosed with developmental delay that would interfere with understanding questions being asked (autism, mental retardation)
• Children with major chronic medical conditions (ASA status III or higher)

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Shriners Hospitals for Children

OTHER

Sponsor Role: lead

Responsible Party

Catherine Ferland

Principle Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Catherine Ferland, PhD

Role: PRINCIPAL_INVESTIGATOR

Shriners Hospitals for Children,Canada

Locations

Shriners Hospital for Children-Canada

Montreal, Quebec, Canada

Countries

Canada

Other Identifiers

A09-M17-17B

Identifier Type: -

Identifier Source: org_study_id