Enhancing Analgesia in Chronic Pain Through Exercise

NCT04862871 | Unknown

• 1 other identifier: IRB-P00034939
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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 (n=10), no exercise (n=10) and healthy control (n=10) 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.

Conditions

Pain; Chronic Widespread Pain; Fibromyalgia

Outcome Measures

Primary Outcomes (1)

• Change in effective connectivity

  Difference in effective connectivity between motor and pain regions of the brain between persons who have completed the PPRC intervention and those on the waitlist. Whole-brain effective connectivity will be evaluated and compared between groups that will be age and sex-matched. Effective connectivity will be calculated using dynamic causal modeling and evaluated using a tapping task. Effective connectivity will be calculated from a motor task requiring participants to complete an active (tapping) and rest (no tapping) condition.

  8 months

Secondary Outcomes (1)

• Thermal sensitivity

  8 months

Study Arms (3)

Healthy Controls

NO INTERVENTION

A cohort (n=10) of participants will be recruited who do not have any neurological conditions and are age and sex-matched to participants in Arms 2 and 3.

Chronic Widespread Pain

NO INTERVENTION

A cohort (n=10) of participants who have not yet begun the exercise program and are currently on the waitlist for the exercise program at the PPRC

Chronic Widespread Pain - Exercise

ACTIVE COMPARATOR

A cohort (n=10) of participants who have completed the exercise program at the PPRC. These individuals will be evaluated the day of their last treatment visit

Behavioral: Physical Activity - Pediatric Pain Rehabilitation Center

Interventions

Physical Activity - Pediatric Pain Rehabilitation Center BEHAVIORAL

While admitted to the Pediatric Pain Rehabilitation Center program, patients receive 1-3 hours of individual and group physical therapy 5 times per week and completed a 30-60 minute home exercise program 9 times per week. The median length of stay for the program is 5 weeks. The amount of aerobic exercise prescribed is individualized to each patient and ranged from 10-20 minutes per session. The duration of aerobic exercise prescribed progressed by 5-10 min weekly until the child reached 20-30 minutes. Patients are instructed to reach a moderate to vigorous intensity of exercise (defined at 5-7/10 rate of perceived exertion). The mode of exercise varied dependent on patient ability and interest. Typical modes of exercise included: walking, running, stationary biking, swimming, sports (i.e., soccer, dance), and online aerobic workouts. Patients were prescribed an individualized 30-60 minute discharge home program using the same structure upon completing the program.

Chronic Widespread Pain - Exercise

Eligibility Criteria

• Age: 10 Years - 24 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Otherwise healthy participants between the ages of 10 and 24
• Actively on the waitlist for, or having completed the exercise program at the PPRC
• Comprehension of instructions
• Parental consent for minors
• Weight less than 250 lbs - limit of MRI table
• Clinical diagnosis of Chronic Widespread Pain

You may not qualify if:

• Preventative medications and opioids
• Metallic implants that will pose harm to the subject (e.g., pacemaker) and/or affect the dat (e.g., braces)
• Significant medical disease (systemic or CNS).
• Active suicidality, psychosis, diagnosed eating disorders, and/or other severe clinically diagnosed neuro-psychiatric conditions
• Pregnant
• Claustrophobia

Sponsors & Collaborators

• Boston Children's Hospital: lead

Study Sites (1)

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

MeSH Terms

Conditions

Pain; Chronic Pain; Fibromyalgia

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Officials

• Scott Holmes, PhD

  Boston Children's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Scott Holmes, PhD

CONTACT

6179196648; scott.holmes@childrens.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Associate

Model Details: Participants will be evaluated in three independent groups (healthy controls, participants who have completed an exercise program, participants who are waiting to complete an exercise program).

Study Record Dates

• First Submitted: April 16, 2021
• First Posted: April 28, 2021
• Study Start: April 1, 2022
• Primary Completion: August 1, 2022
• Study Completion: November 1, 2022
• Last Updated: May 11, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)