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Not yet recruiting NCT07182006

Exercise as Medicine for Pediatric Chronic Pain

No phase Interventional Chronic Pain Child Adolescent

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Aerobic Exercise.
Who it may be relevant to
Registry conditions: Chronic Pain, Child, Adolescent. Basic parameters: 10 years — 17 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Movement as Medicine: Can a Single Bout of Aerobic Exercise Elicit Exercise-induced Hypoalgesia in Youth With and Without Chronic Pain Syndromes?

Overview

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

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.

Interventions

  • Behavioral Aerobic Exercise
    Submaximal cardiovascular endurance testing on a treadmill

Primary outcome measures

  • Pressure Pain Thresholds (PPT) [Time frame: Before and after the intervention at baseline]
  • Offset Analgesia Response [Time frame: Before and after the intervention at baseline]
  • Temporal Summation of Heat Pain [Time frame: Before and after the intervention at baseline]
Secondary outcome measures (9)
  • Fitkids Treadmill Test [Time frame: Single measurement at baseline]
  • Functional Disability Inventory [Time frame: Single measurement at baseline]
  • Tampa Kinesiophobia Scale [Time frame: Single measurement at baseline]
  • Pain Catastrophizing Scale [Time frame: Single assessment at baseline]
  • Fear of Pain Questionnaire Child [Time frame: Single assessment at baseline.]
  • PROMIS Pediatric Pain Interference - Short Form 8a [Time frame: Single assessment at baseline]
  • Central Sensitization Inventory [Time frame: Single assessment at baseline.]
  • Numeric Pain Rating Scale [Time frame: Baseline - before and after intervention]
  • Highly Sensitive Child Scale [Time frame: Single measurement at baseline]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Basic science

Study locations

United States · 1 center
  • Boston Children's Hospital at 2 Brookline Place — Brookline

Publications

  • 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. PMID 38743558
  • 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. PMID 32658151
  • 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. PMID 30904519
  • 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. PMID 11929939
  • 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. PMID 25856681
  • 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. PMID 27661245

Identifiers

NCT: NCT07182006 · P00049713

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗