Exercise as Medicine for Pediatric Chronic Pain

NCT ID: NCT07182006

Last Updated: 2025-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-04-01

Study Completion Date

2027-03-30

Brief Summary

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Youth with chronic pain struggle to go to school, play sports, or spend time with friends and family due to pain. Medications are often ineffective, and aerobic exercise may improve both pain sensitivity and participation in valued life activities. This study will be the first to examine the impact of a single session of intense aerobic exercise on pain sensitivity measures in youth with and without chronic pain syndromes to help determine if aerobic exercise can improve pain and functioning.

Detailed Description

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Pediatric chronic pain syndromes that occur in 11-38% of youth commonly impact participation in school, family, and recreational activities. Pediatric chronic pain and disability can persist into adulthood if left untreated. Central sensitization is an overarching mechanism of pediatric and adult chronic pain syndromes and is conceptualized as an imbalance in the facilitatory and inhibitory pathways that control pain signal traffic in the central nervous system. Aerobic exercise commonly recommended to improve pain and disability, but empirical evidence is lacking. Exercise-induced hypoalgesia (EIH) is a proposed mechanism by which aerobic exercise improves pain sensitivity and is characterized by improved pain sensitivity immediately following exercise. To date, EIH has not been studied in youth with chronic pain syndromes. Insights may reveal potential treatment targets and mechanisms by which aerobic exercise can improve pain and quality of life among youth suffering from chronic pain. This study aims to 1) evaluate and compare EIH responses in youth with and without chronic pain and 2) identify potential biopsychosocial contributors to EIH. The investigators hypothesize that EIH is robust in pain-free youth, and present but attenuated in youth with chronic pain (Aim 1) and that unhelpful beliefs about pain will attenuate the effects of exercise on pain sensitivity (Aim 2). Results from this study will provide highly relevant data to design a clinical trial studying the effects of chronic aerobic exercise on pain and disability in these youth. Identification of effective nonpharmacologic treatments for chronic pain, such as exercise, may also reduce dependence on prescription medications and improve child health.

Conditions

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Chronic Pain Child Adolescent

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Youth with chronic pain and healthy controls will complete all study outcomes in parallel.
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Youth with Chronic Pain Syndromes

Youth with chronic pain will undergo quantitative sensory testing before and immediately after a single bout of intense aerobic exercise.

Group Type EXPERIMENTAL

Aerobic Exercise

Intervention Type BEHAVIORAL

Submaximal cardiovascular endurance testing on a treadmill

Youth without Chronic Pain Syndromes

Youth without chronic pain will undergo quantitative sensory testing before and immediately after a single bout of intense aerobic exercise. They will serve as a control group to determine if the intervention has different effects between groups.

Group Type ACTIVE_COMPARATOR

Aerobic Exercise

Intervention Type BEHAVIORAL

Submaximal cardiovascular endurance testing on a treadmill

Interventions

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Aerobic Exercise

Submaximal cardiovascular endurance testing on a treadmill

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Primary or secondary chronic pain syndrome

Exclusion Criteria

* Allodynia (pain with light touch) at testing sites (non-dominant forearm)
* Self-reported use of opioids in last week
* Comorbid condition for which exercise is deemed unsafe by a physician or the (Physical Activity Readiness Questionnaire+) PARQ+
* unable to safely ambulate on a treadmill
Minimum Eligible Age

10 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Boston Children's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Julie Shulman

Physical Therapy Scientist

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Boston Children's Hospital at 2 Brookline Place

Brookline, Massachusetts, United States

Site Status

Countries

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United States

Central Contacts

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Julie Shulman, PhD, DPT

Role: CONTACT

781-216-1650

Facility Contacts

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Julie Shulman, PT, DPT, PhD, PCS

Role: primary

781-216-1650

Avery Savage, BS

Role: backup

781-216-1650

References

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Chambers CT, Dol J, Tutelman PR, Langley CL, Parker JA, Cormier BT, Macfarlane GJ, Jones GT, Chapman D, Proudfoot N, Grant A, Marianayagam J. The prevalence of chronic pain in children and adolescents: a systematic review update and meta-analysis. Pain. 2024 Oct 1;165(10):2215-2234. doi: 10.1097/j.pain.0000000000003267. Epub 2024 May 15.

Reference Type BACKGROUND
PMID: 38743558 (View on PubMed)

Shulman J, Zurakowski D, Keysor J, Jervis K, Sethna NF. Offset analgesia identifies impaired endogenous pain modulation in pediatric chronic pain disorders. Pain. 2020 Dec;161(12):2852-2859. doi: 10.1097/j.pain.0000000000001984.

Reference Type BACKGROUND
PMID: 32658151 (View on PubMed)

Rice D, Nijs J, Kosek E, Wideman T, Hasenbring MI, Koltyn K, Graven-Nielsen T, Polli A. Exercise-Induced Hypoalgesia in Pain-Free and Chronic Pain Populations: State of the Art and Future Directions. J Pain. 2019 Nov;20(11):1249-1266. doi: 10.1016/j.jpain.2019.03.005. Epub 2019 Mar 21.

Reference Type BACKGROUND
PMID: 30904519 (View on PubMed)

Grill JD, Coghill RC. Transient analgesia evoked by noxious stimulus offset. J Neurophysiol. 2002 Apr;87(4):2205-8. doi: 10.1152/jn.00730.2001.

Reference Type BACKGROUND
PMID: 11929939 (View on PubMed)

Stolzman S, Danduran M, Hunter SK, Bement MH. Pain Response after Maximal Aerobic Exercise in Adolescents across Weight Status. Med Sci Sports Exerc. 2015 Nov;47(11):2431-40. doi: 10.1249/MSS.0000000000000678.

Reference Type BACKGROUND
PMID: 25856681 (View on PubMed)

Stolzman S, Bement MH. Does Exercise Decrease Pain via Conditioned Pain Modulation in Adolescents? Pediatr Phys Ther. 2016 winter;28(4):470-3. doi: 10.1097/PEP.0000000000000312.

Reference Type BACKGROUND
PMID: 27661245 (View on PubMed)

Other Identifiers

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P00049713

Identifier Type: -

Identifier Source: org_study_id

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