Clinical trial NCT04308044: Clinical Assessment of Pain Processes in Pediatric Patients With Chronic Musculoskeletal Pain
Official title: Clinical Assessment of Pain Processes in Pediatric Patients With Chronic Musculoskeletal Pain
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Pain
Keywords: Conditioned Pain Modulation
Chronic Musculoskeletal Pain
Quantitative Sensory Testing
Pain Management
Lead sponsor: Shriners Hospitals for Children
Sponsor class: OTHER
First posted: 2020-03-13
Enrollment: 518
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients will be recruited from outpatient clinics at the Shriners Hospitals for Children - Canada. Healthy participants will be recruited through word of mouth and recruitment advertisements in local magazines and social media. In collaboration with the public relations department of the hospital, previously-edited videos demonstrating the rationale and safety of the QST procedures mixed with interviews of past subjects will also be shared to promote the project and minimize potential concerns regarding our clinical assessment of pain.

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.

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)

Primary outcomes:
measure: Mechanical detection threshold (grams) as measured with von Frey filaments
timeFrame: Completed during study visit (5 minutes).
measure: Dynamic mechanical allodynia (numerical pain intensity using Faces Pain Scale -Revised scores 0-10) as measured with a standardized brush (Somedic SENSELab - Brush-05)
timeFrame: Completed during study visit (5 minutes).
measure: Vibration detection threshold (Hertz) as measured with a Rydel-Seiffer graded tuning fork (64 Hz)
timeFrame: Completed during study visit (5 minutes).
measure: Temporal mechanical summation (numerical pain intensity using Faces Pain Scale -Revised scores 0-10) as measured with the Neuropen (Owen Mumford) with disposable Neurotips
timeFrame: Completed during study visit (15 minutes).
measure: Pain pressure threshold (Newtons) as measured with an algometer.
timeFrame: Completed during study visit (5 minutes).
measure: Conditioned pain modulation (CPM) efficiency, a physiological parameter calculated as the percentage difference between the average pain intensity (0-10) reported during a thermode (heat) test before and after a cold water submersion bath test.
timeFrame: Completed during study visit (20 minutes).
measure: Electroencephalography (EEG) (μV) as measured with a 24-electrode wireless EEG headset (DSI-24, Wearable Sensing)
timeFrame: Completed during study visit (5 minutes).
measure: Biochemical assessment and genomic analysis of blood sample (10ml), drawn by research nurse.
timeFrame: The blood samples will be analyzed within 1 year of the study visit.
measure: Insole assessment (N; N/cm2; mm/s; mm) as measured with Moticon© sensor insoles
timeFrame: Completed during study visit (5 minutes).
measure: Total score on Neuropathic Pain Questionnaire (DN4) (0-10) assessing the probability of neuropathic pain (score greater than 4 indicates neuropathic pain).
timeFrame: Completed during study visit (5 minutes).
measure: Total Score of the Functional Disability Inquiry (0-60). Higher scores indicate greater activity limitations during the past 2 weeks.
timeFrame: Completed during study visit (5 minutes).
measure: Total Subscale Score of the Adolescent Pediatric Pain Tool (APPT), which evaluates the intensity, location, and quality (including affective, evaluative, sensory, and temporal) dimensions of pain.
timeFrame: Completed during study visit (5 minutes).
measure: Global Score of the Pittsburgh Sleep Quality Index (0-21). Higher scores indicate a worse sleep quality (>5 indicates "poor sleeper").
timeFrame: Completed during study visit (5 minutes).
measure: Total Anxiety Score and Total Internalizing Scale on the Revised Children Anxiety and Depression Scale (RCADS) (0-47) (t-score of 65 = borderline clinical threshold, t-score 70 = above clinical threshold)
timeFrame: Completed during study visit (5 minutes).
measure: Total Score of the Pain Catastrophizing Scale (0-52). Higher scores indicate higher levels of pain-related anxiety.
timeFrame: Completed during study visit (5 minutes).
measure: Score of Trait Anxiety of the State-Trait Anxiety Scale (20-60). Higher scores indicate greater trait anxiety.
timeFrame: Completed during study visit (5 minutes).
Secondary outcomes:
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: Shriners Hospital for Children-Canada
state: Quebec
Study officials:
affiliation: Shriners Hospitals for Children,Canada
name: Catherine Ferland, PhD
role: PRINCIPAL_INVESTIGATOR
References: