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Exercise as Medicine for Pediatric Chronic Pain

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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07182006
Enrollment
66
Registered
2025-09-19
Start date
2026-04-01
Completion date
2027-03-30
Last updated
2025-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adolescent, Child, Chronic Pain

Keywords

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

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.

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

BEHAVIORALAerobic Exercise

Submaximal cardiovascular endurance testing on a treadmill

Sponsors

Boston Children's Hospital
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Intervention model description

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

Eligibility

Sex/Gender
ALL
Age
10 Years to 17 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Pressure Pain Thresholds (PPT)Before and after the intervention at baselineA 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.
Offset Analgesia ResponseBefore and after the intervention at baselinePercent decrease in pain reported between T2 and T3 interval of the offset analgesia test. Higher values represent greater pain inhibition.
Temporal Summation of Heat PainBefore and after the intervention at baselineTo 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.

Secondary

MeasureTime frameDescription
Pain Catastrophizing ScaleSingle assessment at baselineLikert type patient reported outcome of worry related to pain. HIgher score represent greater worries related to pain.
Fear of Pain Questionnaire ChildSingle assessment at baseline.Patient reported outcome of pain related fear. Higher scores reflect greater fear.
PROMIS Pediatric Pain Interference - Short Form 8aSingle assessment at baselinePatient reported outcome of pain impact on life. Higher score reflect greater pain interference.
Fitkids Treadmill TestSingle measurement at baselineTime to exhaustion (TTE) on the FTT provides an objective, norm-referenced marker of aerobic capacity in youth and is defined as the total time completed on the test, excluding the warm-up and cool-down phases. Data recorded includes TTE, rate of perceived exertion (Borg Scale), and maximum heart rate. Successful completion of the exercise session will be defined as achievement of \> 85% age-predicted maximum heart rate. Greater TTE represents greater aerobic fitness.
Numeric Pain Rating ScaleBaseline - before and after interventionSelf-reported pain intensity on an 11-point likert scale. Higher scores represent greater pain intensity.
Highly Sensitive Child ScaleSingle measurement at baselinePatient reported outcome of sensitivity to common daily sensory stimuli. Higher scores represent greater sensitivity.
Central Sensitization InventorySingle assessment at baseline.Patient reported outcome of the frequency of symptoms commonly experienced by persons with chronic pain. Higher score represent greater central sensitization.
Functional Disability InventorySingle measurement at baseline15-item Likert scale of pain related disability. Higher scores represent greater disability.
Tampa Kinesiophobia ScaleSingle measurement at baselineLikert type scale of movement related fear. Higher scores indicate greater fear.

Countries

United States

Contacts

Primary ContactJulie Shulman, PhD, DPT
julie.shulman@childrens.harvard.edu781-216-1650

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026