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

NCT04308044 | Unknown

• 1 other identifier: A09-M17-17B
• Study Type: observational
• Target: 518
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Pain

Keywords

Conditioned Pain Modulation; Chronic Musculoskeletal Pain; Quantitative Sensory Testing; Pain Management

Outcome Measures

Primary Outcomes (16)

• Mechanical detection threshold (grams) as measured with von Frey filaments

  Completed during study visit (5 minutes).

• 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).

• Vibration detection threshold (Hertz) as measured with a Rydel-Seiffer graded tuning fork (64 Hz)

  Completed during study visit (5 minutes).

• 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).

• Pain pressure threshold (Newtons) as measured with an algometer.

  Completed during study visit (5 minutes).

• 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).

• Electroencephalography (EEG) (μV) as measured with a 24-electrode wireless EEG headset (DSI-24, Wearable Sensing)

  Completed during study visit (5 minutes).

• 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.

• 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).

• 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).

• 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).

• 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).

• 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).

• 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).

• 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).

• 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).

Study Arms (2)

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.

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.

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Shriners Hospitals for Children: lead

Study Sites (1)

Shriners Hospital for Children-Canada

Montreal, Quebec, H4A0A9, Canada

Location

Biospecimen

Retention: SAMPLES WITH DNA

10ml whole blood sample

MeSH Terms

Conditions

Chronic Pain; Agnosia

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Study Officials

• Catherine Ferland, PhD

  Shriners Hospitals for Children,Canada

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: March 9, 2020
• First Posted: March 13, 2020
• Study Start: January 23, 2018
• Primary Completion: September 1, 2022
• Study Completion: November 1, 2022
• Last Updated: May 4, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)