Exercise as Medicine for Pediatric Chronic Pain

NCT07182006 | Not Yet Recruiting

• 1 other identifier: P00049713
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Pain; Child; Adolescent

Keywords

aerobic exercise; chronic pain; pediatric; quantitative sensory testing; endogenous pain modulation

Outcome Measures

Primary Outcomes (3)

• Pressure Pain Thresholds (PPT)

  A pressure algometer is applied 3 times to 2 sites: the dominant quadriceps and deltoid using the Force Ten FDX pressure gauge (Wagner Instruments, Greenwich, CT). The pressure at which the participant reports pain is recorded and averaged over the three trials. Higher PPTs represent less pain sensitivity.

  Before and after the intervention at baseline

• Offset Analgesia Response

  Percent decrease in pain reported between T2 and T3 interval of the offset analgesia test. Higher values represent greater pain inhibition.

  Before and after the intervention at baseline

• Temporal Summation of Heat Pain

  To evaluate constant noxious heat pain summation, a noxious heat stimulus (60/100 on a visual analogue scale) is held for 60 seconds. Temporal summation is defined by an exponential increase in pain at the test end relative to the start; greater values represent greater pain facilitation.

  Before and after the intervention at baseline

Secondary Outcomes (9)

• Fitkids Treadmill Test

  Single measurement at baseline

• Functional Disability Inventory

  Single measurement at baseline

• Tampa Kinesiophobia Scale

  Single measurement at baseline

• Pain Catastrophizing Scale

  Single assessment at baseline

• Fear of Pain Questionnaire Child

  Single assessment at baseline.

Study Arms (2)

Youth with Chronic Pain Syndromes

EXPERIMENTAL

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

Behavioral: Aerobic Exercise

Youth without Chronic Pain Syndromes

ACTIVE COMPARATOR

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.

Behavioral: Aerobic Exercise

Interventions

Aerobic Exercise BEHAVIORAL

Submaximal cardiovascular endurance testing on a treadmill

Youth with Chronic Pain Syndromes; Youth without Chronic Pain Syndromes

Eligibility Criteria

• Age: 10 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Primary or secondary chronic pain syndrome

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston Children's Hospital: lead

Study Sites (1)

Boston Children's Hospital at 2 Brookline Place

Brookline, Massachusetts, 02445, United States

Location

Related Publications (6)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Chronic Pain

Interventions

Exercise

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Julie Shulman, PhD, DPT

CONTACT

781-216-1650; julie.shulman@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: Physical Therapy Scientist

Model Details: Youth with chronic pain and healthy controls will complete all study outcomes in parallel.

Study Record Dates

• First Submitted: September 9, 2025
• First Posted: September 19, 2025
• Study Start: April 1, 2026
• Primary Completion (Estimated): January 30, 2027
• Study Completion (Estimated): March 30, 2027
• Last Updated: September 19, 2025

Record last verified: 2025-09

Locations

US (1)