Exercise as Medicine for Pediatric Chronic Pain

Not Applicable

Not yet recruiting

• Conditions: Chronic Pain; Adolescent; Child

• Registration Number: NCT07182006
• Lead Sponsor: Boston Children's Hospital

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.

Study Timeline

• Status Verified: 2025-09
• Study First Submitted: 2025-09-09
• Study First Submitted QC: 2025-09-16
• Last Update Submitted: 2025-09-16
• Study First Posted: 2025-09-19
• Last Update Posted: 2025-09-19
• Study Start: 2026-04-01
• Primary Completion: 2027-01-30
• Study Completion: 2027-03-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 66

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Pressure Pain Thresholds (PPT)	Before and after the intervention at baseline	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.
Offset Analgesia Response	Before and after the intervention at baseline	Percent decrease in pain reported between T2 and T3 interval of the offset analgesia test. Higher values represent greater pain inhibition.
Temporal Summation of Heat Pain	Before and after the intervention at baseline	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.

Secondary Outcome Measures

Name	Time	Method
Fitkids Treadmill Test	Single measurement at baseline	Time 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.
Functional Disability Inventory	Single measurement at baseline	15-item Likert scale of pain related disability. Higher scores represent greater disability.
Tampa Kinesiophobia Scale	Single measurement at baseline	Likert type scale of movement related fear. Higher scores indicate greater fear.
Pain Catastrophizing Scale	Single assessment at baseline	Likert type patient reported outcome of worry related to pain. HIgher score represent greater worries related to pain.
Fear of Pain Questionnaire Child	Single assessment at baseline.	Patient reported outcome of pain related fear. Higher scores reflect greater fear.
PROMIS Pediatric Pain Interference - Short Form 8a	Single assessment at baseline	Patient reported outcome of pain impact on life. Higher score reflect greater pain interference.
Central Sensitization Inventory	Single assessment at baseline.	Patient reported outcome of the frequency of symptoms commonly experienced by persons with chronic pain. Higher score represent greater central sensitization.
Numeric Pain Rating Scale	Baseline - before and after intervention	Self-reported pain intensity on an 11-point likert scale. Higher scores represent greater pain intensity.
Highly Sensitive Child Scale	Single measurement at baseline	Patient reported outcome of sensitivity to common daily sensory stimuli. Higher scores represent greater sensitivity.

Trial Locations

Locations (1)

Boston Children's Hospital at 2 Brookline Place; 🇺🇸 Brookline, Massachusetts, United States