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

Chronic Pain Clinical Trial

— MSK  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04308044
• Other study ID #: A09-M17-17B
• Status: Active, not recruiting
• Start date: January 23, 2018
• Est. completion date: November 2022

Study information

• Verified date: May 2022
• Source: Shriners Hospitals for Children
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 518
• Est. completion date: November 2022
• Est. primary completion date: September 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 10 Years to 18 Years

Eligibility

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)

Related Conditions & MeSH terms

• Chronic Pain
• Musculoskeletal Pain

Locations

Country	Name	City	State
Canada	Shriners Hospital for Children-Canada	Montréal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Shriners Hospitals for Children

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mechanical detection threshold (grams) as measured with von Frey filaments		Completed during study visit (5 minutes).
Primary	Dynamic mechanical allodynia (numerical pain intensity using Faces Pain Scale -Revised scores 0-10) as measured with a standardized brush (Somedic SENSELab - Brush-05)		Completed during study visit (5 minutes).
Primary	Vibration detection threshold (Hertz) as measured with a Rydel-Seiffer graded tuning fork (64 Hz)		Completed during study visit (5 minutes).
Primary	Temporal mechanical summation (numerical pain intensity using Faces Pain Scale -Revised scores 0-10) as measured with the Neuropen (Owen Mumford) with disposable Neurotips		Completed during study visit (15 minutes).
Primary	Pain pressure threshold (Newtons) as measured with an algometer.		Completed during study visit (5 minutes).
Primary	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.		Completed during study visit (20 minutes).
Primary	Electroencephalography (EEG) (µV) as measured with a 24-electrode wireless EEG headset (DSI-24, Wearable Sensing)		Completed during study visit (5 minutes).
Primary	Biochemical assessment and genomic analysis of blood sample (10ml), drawn by research nurse.	A molecular assessment of monoamines involved in the dopaminergic and adrenergic pain (pathways related to the endogenous pain inhibitory system (dopamine, serotonin, epinephrine,norepinephrine) will be performed.; Genomics analyses will be done to analyze specific single-nucleotide polymorphisms (SNPs). This process involves amplification of specific DNA fragments by polymerase chain reaction (PCR) followed by analysis on an optical plate for specific genetic polymorphisms, to identify which patients carry such polymorphisms.	The blood samples will be analyzed within 1 year of the study visit.
Primary	Insole assessment (N; N/cm2; mm/s; mm) as measured with Moticon© sensor insoles	Forty participants who agree to participate in the insole assessment will be asked to stand on sensory insoles for a duration of fifteen seconds to measure the forces, pressures and center of pressure in their feet. The measurement data obtained using the Moticon© insoles will be aggregated for analysis of plantar pressure distribution, which will be performed using the Moticon© software.	Completed during study visit (5 minutes).
Primary	Total score on Neuropathic Pain Questionnaire (DN4) (0-10) assessing the probability of neuropathic pain (score greater than 4 indicates neuropathic pain).	2 domains (Interview (0-7) and Examination (0-3) of the Patient) Completed by MSK chronic pain participants.	Completed during study visit (5 minutes).
Primary	Total Score of the Functional Disability Inquiry (0-60). Higher scores indicate greater activity limitations during the past 2 weeks.	Completed by MSK chronic pain participants.	Completed during study visit (5 minutes).
Primary	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.	The APPT provides five subscale scores: 1) the number of pain sites (alternatively, the number of pain segments) as a measure of pain location from marks on a body outline; 2) a pain intensity score measured by a 10-centimeter line known as the Word Graphic Rating Scale (WGRS) and anchored by words no pain, little, medium, large, worst possible pain; 3) the number of pain quality descriptors, which yields percent scores for the sensory, affective, evaluative subscales; 4) the number of temporal descriptors, which yields a percent temporal subscale; and (5) the percent of total pain quality and temporal descriptors as a total subscale.; Completed by MSK chronic pain participants.	Completed during study visit (5 minutes).
Primary	Global Score of the Pittsburgh Sleep Quality Index (0-21). Higher scores indicate a worse sleep quality (>5 indicates "poor sleeper").	Completed by all participants	Completed during study visit (5 minutes).
Primary	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)	The RCADS is intended to assess children's report of symptoms corresponding to selected DSM-IV anxiety disorders and depression. .; Scale yields Total Anxiety Score (5 anxiety subscales: separation anxiety disorder, social phobia, generalized anxiety disorder, panic disorder, obsessive compulsive disorder), which gives an overall index of anxiety levels, and Total Internalizing Scale (sum of all 6 subscales, including major depression subscale), which provides an estimate of the total level of internalising symptoms.; Completed by all participants.	Completed during study visit (5 minutes).
Primary	Total Score of the Pain Catastrophizing Scale (0-52). Higher scores indicate higher levels of pain-related anxiety.	Completed by all participants.	Completed during study visit (5 minutes).
Primary	Score of Trait Anxiety of the State-Trait Anxiety Scale (20-60). Higher scores indicate greater trait anxiety.	Completed by healthy control participant only.	Completed during study visit (5 minutes).