Ignite Creation Date:
2024-05-06 @ 4:05 PM
Last Modification Date:
2024-10-26 @ 2:03 PM
Study NCT ID:
NCT04862871
Status:
UNKNOWN
Last Update Posted:
2022-05-11
First Post:
2021-04-16
Brief Title:
Enhancing Analgesia in Chronic Pain Through Exercise
Sponsor:
Boston Childrens Hospital
Organization:
Boston Childrens Hospital
Study Overview
Official Title:
Enhancing Analgesia in Chronic Pain Through Exercise Responsivity of Sensory-Motor Networks and Factors That Moderate the Analgesic Response
Status:
UNKNOWN
Status Verified Date:
2022-05
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Background Current pain management strategies for pediatric patients are not integrating the analgesic potential of movement-based therapies To date experiencing a painful stimulus has been known to disrupt motor activity in an attempt to minimize injury However physical activity even when it increases ongoing pain initially has been shown to significantly reduce pain symptoms eventually through neuromodulation In both acute and chronic pain cohorts exercise protocols and neuromodulation paradigms have produced exercise-related analgesia Problem It is not currently understood which brain regions are implicated in exercise-based analgesia and what brain regions moderate this response
Approach The investigators intend to provide a physical activity intervention designed to promote exercise-induced analgesia This intervention will be performed in a group of pediatric subjects with Chronic Widespread Pain Disorder An exercise n10 no exercise n10 and healthy control n10 group will be recruited Aims This study has three aims 1 To understand how thermal pain sensitivity pain symptoms and motor performance are impacted in patients with chronic pain after an exercise-based intervention 2 To evaluate the brain regions involved in a simple motor task as well as how motor activity influences activity in pain regions of the brain 3 To evaluate the network structure of the brain with special emphasis on motor and pain regions in youth with a pain disorder who have undergone an exercise-based intervention Exercise-based therapy in pediatric subjects with a chronic pain condition is predicted to reduce pain symptom reporting through biasing activity in pain regions during motor performance Significance Findings from this investigation will address the clinical side of pain management strategies and provide potential therapeutic targets and feasibility data The investigators anticipate that findings will show how pain and motor regions of the brain interact at the network level and if this interaction can be modulated through exercise Findings will also evaluate the brain regions that mediate the analgesic properties of an exercise-based pain therapy and provide future therapeutic targets
Approach The investigators intend to provide a physical activity intervention designed to promote exercise-induced analgesia This intervention will be performed in a group of pediatric subjects with Chronic Widespread Pain Disorder An exercise n10 no exercise n10 and healthy control n10 group will be recruited Aims This study has three aims 1 To understand how thermal pain sensitivity pain symptoms and motor performance are impacted in patients with chronic pain after an exercise-based intervention 2 To evaluate the brain regions involved in a simple motor task as well as how motor activity influences activity in pain regions of the brain 3 To evaluate the network structure of the brain with special emphasis on motor and pain regions in youth with a pain disorder who have undergone an exercise-based intervention Exercise-based therapy in pediatric subjects with a chronic pain condition is predicted to reduce pain symptom reporting through biasing activity in pain regions during motor performance Significance Findings from this investigation will address the clinical side of pain management strategies and provide potential therapeutic targets and feasibility data The investigators anticipate that findings will show how pain and motor regions of the brain interact at the network level and if this interaction can be modulated through exercise Findings will also evaluate the brain regions that mediate the analgesic properties of an exercise-based pain therapy and provide future therapeutic targets
Detailed Description:
This investigation is aimed at understanding how an exercise program currently performed at the Pediatric Pain Rehabilitation Center PPRC at Boston Childrens Hospital designed for individuals with chronic widespread pain is associated with pain relief and how this pain relief relates to changes in the brain The specific aimsobjectives are to explore the following
Aim 1 - Pain and sensorimotor behavior To understand how thermal pain sensitivity pain symptoms and motor performance are impacted in children with chronic pain after an exercise-based intervention Sensory testing for Hot Cold will be collected using Quantitative Sensory Testing QST to establish pain thresholds To address motor performance we will perform the Bruininks-Oseretsky Test BOT 1 of motor proficiency examining muscle power strength endurance Pain symptom levels will be evaluated using self-report questionnaires that address fear of pain pain catastrophizing and pain symptom load
Aim 2 - Defining hierarchies during motor performance To evaluate the brain regions involved in a simple motor task as well as how motor activity influences activity in pain regions Participants will perform a tapping task within the MRI scanner to evaluate the brain regions that are active during motor control 2 Functional magnetic resonance images will be processed using dynamic causal modeling DCM to evaluate effective connectivity Figure 2 during task performance Brain regions evaluated in DCM will be defined by the healthy control cohort
Aim 3 - Network structure To evaluate the network structure of the brain with emphasis on motor and pain regions in persons with a pain disorder who have undergone an exercise intervention Graph theory analyses implemented using resting-state functional magnetic resonance imaging will be performed to extract metrics reflecting network efficiency nodal degree and nodal centrality Structural metrics eg cortical thickness and white matter connectivity will be collected as nuisance variables Correlation analyses will be performed between network metrics and behavior fear of pain pain catastrophizing motor performance to evaluate their influence over network reorganization observed from the exercise intervention Brain regions that define canonical pain and motor networks will be indexed from the healthy control group
Aim 1 - Pain and sensorimotor behavior To understand how thermal pain sensitivity pain symptoms and motor performance are impacted in children with chronic pain after an exercise-based intervention Sensory testing for Hot Cold will be collected using Quantitative Sensory Testing QST to establish pain thresholds To address motor performance we will perform the Bruininks-Oseretsky Test BOT 1 of motor proficiency examining muscle power strength endurance Pain symptom levels will be evaluated using self-report questionnaires that address fear of pain pain catastrophizing and pain symptom load
Aim 2 - Defining hierarchies during motor performance To evaluate the brain regions involved in a simple motor task as well as how motor activity influences activity in pain regions Participants will perform a tapping task within the MRI scanner to evaluate the brain regions that are active during motor control 2 Functional magnetic resonance images will be processed using dynamic causal modeling DCM to evaluate effective connectivity Figure 2 during task performance Brain regions evaluated in DCM will be defined by the healthy control cohort
Aim 3 - Network structure To evaluate the network structure of the brain with emphasis on motor and pain regions in persons with a pain disorder who have undergone an exercise intervention Graph theory analyses implemented using resting-state functional magnetic resonance imaging will be performed to extract metrics reflecting network efficiency nodal degree and nodal centrality Structural metrics eg cortical thickness and white matter connectivity will be collected as nuisance variables Correlation analyses will be performed between network metrics and behavior fear of pain pain catastrophizing motor performance to evaluate their influence over network reorganization observed from the exercise intervention Brain regions that define canonical pain and motor networks will be indexed from the healthy control group
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None