Aerobic Exercise for Pediatric Chronic Pain

Overseen By Julie Shulman, PhD, DPT

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Boston Children's Hospital

Must not be taking: Opioids

Disqualifiers: Allodynia, Unsafe exercise conditions, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a single session of intense aerobic exercise can reduce pain sensitivity and improve daily functioning in young people. It targets youth who struggle to attend school, play sports, or socialize due to chronic pain. Participants, whether they have a chronic pain syndrome or not, will perform the same exercise to assess its effects. This trial suits youth dealing with chronic pain syndrome who can safely exercise on a treadmill. As an unphased trial, it offers a unique opportunity for participants to contribute to understanding how exercise affects chronic pain in youth.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you've used opioids in the last week.

What prior data suggests that aerobic exercise is safe for youth with and without chronic pain?

Previous studies have found aerobic exercise safe and feasible for children with long-term health issues. Research shows that exercise can reduce pain and increase participation in daily activities. For example, children with juvenile idiopathic arthritis (a type of joint swelling) have safely participated in exercise programs. Another study suggested that physical activity is safe and beneficial for those with sickle cell disease, a condition affecting blood cells. So far, exercise has been well-tolerated and has not shown any harmful effects in these groups. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike standard treatments for pediatric chronic pain, which often include medications like NSAIDs, opioids, or anticonvulsants, aerobic exercise offers a drug-free alternative that could potentially enhance pain management. Researchers are excited about this approach because exercise is known to release endorphins, the body's natural pain relievers, and improve overall physical function and mood. Additionally, aerobic exercise might provide immediate benefits after just a single session, unlike some medications that take longer to show effects. This method could be particularly appealing for young patients, offering a holistic and active way to manage chronic pain without the side effects associated with pharmaceuticals.

What evidence suggests that aerobic exercise might be an effective treatment for chronic pain?

This trial will compare the effects of aerobic exercise on youth with chronic pain syndromes to those without. Studies have shown that aerobic exercise can reduce pain sensitivity and help children with chronic pain engage more easily in daily activities. Research suggests that aerobic exercise can lead to less pain and improved mood. However, some studies have found mixed results, indicating that effectiveness can vary. Despite this, exercise is generally considered safe and beneficial for most children with chronic conditions. While results aren't entirely clear, promising evidence suggests that aerobic exercise could be a helpful tool in managing chronic pain in children. ^{1 3 6 7 8}

Are You a Good Fit for This Trial?

This trial is for children and adolescents who experience chronic pain, which affects their daily activities like school and sports. Participants should be able to perform aerobic exercise but haven't found relief through medications.

Inclusion Criteria

I have long-term chronic pain.

Exclusion Criteria

I feel pain when my non-dominant forearm is lightly touched.

Self-reported use of opioids in the last week

Comorbid condition for which exercise is deemed unsafe by a physician or the Physical Activity Readiness Questionnaire (PARQ+)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants undergo quantitative sensory testing and baseline assessments before the exercise intervention

1 day

1 visit (in-person)

Intervention

Participants engage in a single bout of intense aerobic exercise followed by immediate post-exercise sensory testing

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the exercise intervention

1-2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Aerobic Exercise

Trial Overview The study investigates the effects of a single session of intense aerobic exercise on how sensitive young people are to pain. It aims to see if this type of exercise can help improve their pain levels and ability to do everyday things.

How Is the Trial Designed?

Group I: Youth with Chronic Pain Syndromes Experimental Treatment 1 Intervention

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

Group II: Youth without Chronic Pain Syndromes Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

Boston Children's Hospital

Lead Sponsor

Trials

801

Recruited

5,584,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11654719/

Longitudinal pain outcomes following an intensive ... Statistically significant improvement in functional disability, pain, and depressive symptoms was demonstrated across the four time points.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT07182006

Exercise as Medicine for Pediatric Chronic Pain | ... Medications are often ineffective, and aerobic exercise may improve both pain sensitivity and participation in valued life activities. This study will be the ...

3. researchgate.net researchgate.net/publication/328461270_A_systematic_review_and_quantitative_analysis_on_the_impact_of_aerobic_exercise_on_pain_intensity_in_children_with_chronic_pain

A systematic review and quantitative analysis on the impact ... A systematic review analyzed the effectiveness of aerobic exercise in a pediatric population with chronic pain and found inconclusive results in the only three ...

4. bmcpediatr.biomedcentral.com bmcpediatr.biomedcentral.com/articles/10.1186/s12887-018-1377-3

Physical activity for children with chronic disease; a narrative ... PA is important and safe for most children with a chronic disease, however exercise prescription should involve the entire health care team.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3766388/

Bidirectional Associations between Pain and Physical Activity ... As shown in Table 2, mean physical activity levels were 14% lower for adolescents with chronic pain as compared to healthy adolescents and peak physical ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10339856/

Physical activity and education about ... - PubMed Central Children and adolescents with chronic pain report disability and a low mood; they socialise less with their friends, and recognise pain as an obstacle to ...

7. academic.oup.com academic.oup.com/jpepsy/advance-article/doi/10.1093/jpepsy/jsaf055/8210598

Physical activity among adolescents and young adults living ... Physical activity is recommended for pediatric chronic pain and is safe, feasible, and beneficial for individuals with SCD, yet uptake is ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S245186542300162X

A protocol for a single-center, pilot randomized controlled trial Physical activity is highly effective in managing chronic pain in children and adolescents, however, evidence about the combination of physical activity ...