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Chronic PainNCT07182006

Exercise as Medicine for Pediatric Chronic Pain

A study testing Aerobic Exercise in people with Chronic Pain and Child, run by Boston Children's Hospital at 1 site in United States.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 10 to 17 yearsHealthy volunteers can take part
Conditions the study is for
Chronic Pain, Child, Adolescent
What is being tested?
Aerobic Exercise
Could I receive a placebo?
No, everyone receives an active treatment
How many people
66 participants
Where
1 siteUnited States
Study dates
1 Apr 2026to 30 Mar 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 10 to 17 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • Primary or secondary chronic pain syndrome

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site

  • Boston Children's Hospital at 2 Brookline Place

    Brookline, Massachusetts, 02445

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
Aerobic Exercise
Keywords
aerobic exercise, chronic pain, pediatric, quantitative sensory testing, endogenous pain modulation
Medical subject headings
Chronic Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Aerobic ExerciseBehavioural

    Submaximal cardiovascular endurance testing on a treadmill

Study groups in NCT07182006
Study groupRoleWhat they receive
Youth with Chronic Pain SyndromesExperimentalYouth with chronic pain will undergo quantitative sensory testing before and immediately after a single bout of intense aerobic exercise.
Receives: Behavioral: Aerobic Exercise
Youth without Chronic Pain SyndromesActive comparatorYouth 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.
Receives: Behavioral: Aerobic Exercise

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Before and after the intervention at baseline

  2. Offset Analgesia Response

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

    Measured: Before and after the intervention at baseline

  3. 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.

    Measured: Before and after the intervention at baseline

Secondary outcomes (9)

  1. Fitkids Treadmill Test

    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.

    Measured: Single measurement at baseline

  2. Functional Disability Inventory

    15-item Likert scale of pain related disability. Higher scores represent greater disability.

    Measured: Single measurement at baseline

  3. Tampa Kinesiophobia Scale

    Likert type scale of movement related fear. Higher scores indicate greater fear.

    Measured: Single measurement at baseline

  4. Pain Catastrophizing Scale

    Likert type patient reported outcome of worry related to pain. HIgher score represent greater worries related to pain.

    Measured: Single assessment at baseline

  5. Fear of Pain Questionnaire Child

    Patient reported outcome of pain related fear. Higher scores reflect greater fear.

    Measured: Single assessment at baseline.

  6. PROMIS Pediatric Pain Interference - Short Form 8a

    Patient reported outcome of pain impact on life. Higher score reflect greater pain interference.

    Measured: Single assessment at baseline

  7. Central Sensitization Inventory

    Patient reported outcome of the frequency of symptoms commonly experienced by persons with chronic pain. Higher score represent greater central sensitization.

    Measured: Single assessment at baseline.

  8. Numeric Pain Rating Scale

    Self-reported pain intensity on an 11-point likert scale. Higher scores represent greater pain intensity.

    Measured: Baseline - before and after intervention

  9. Highly Sensitive Child Scale

    Patient reported outcome of sensitivity to common daily sensory stimuli. Higher scores represent greater sensitivity.

    Measured: Single measurement at baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Sep 2025
  2. Study start1 Apr 2026
  3. Primary completion30 Jan 2028 (estimated)
  4. Study completion30 Mar 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
Youth with chronic pain and healthy controls will complete all study outcomes in parallel.
Masking
None (open label)
Enrolment
66 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07182006
Sponsor's protocol ID
P00049713
Status last verified
Oct 2026
First submitted
9 Sep 2025
Last updated
22 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: IPD not covered by the informed consent process will not be shared for privacy reasons.

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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 27661245

Questions about this trial

What is this clinical trial studying?

A study testing Aerobic Exercise in people with Chronic Pain and Child, run by Boston Children's Hospital at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pressure Pain Thresholds (PPT) (time frame: Before and after the intervention at baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07182006, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.

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