Exercise as Medicine for Pediatric Chronic Pain
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age10-17
SponsorBoston Children's Hospital
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Primary or secondary chronic pain syndrome
Disqualifiers
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 design
Design model
Parallel
Treatments tested in this trial
Aerobic Exercise
BehavioralSubmaximal cardiovascular endurance testing on a treadmill
Treatment groups
66 Participants
are divided into 2 treatment groupsGroup A: Youth with Chronic Pain SyndromesExperimental treatment 1 intervention
Group B: Youth without Chronic Pain SyndromesActive comparator 1 intervention
Trial outcomes
Primary outcomes
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.
Time frame
Before and after the intervention at baseline2
Offset Analgesia Response
Percent decrease in pain reported between T2 and T3 interval of the offset analgesia test. Higher values represent greater pain inhibition.
Time frame
Before and after the intervention at baseline3
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.
Time frame
Before and after the intervention at baselineSecondary outcomes
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.
Time frame
Single measurement at baseline2
Functional Disability Inventory
15-item Likert scale of pain related disability. Higher scores represent greater disability.
Time frame
Single measurement at baseline3
Tampa Kinesiophobia Scale
Likert type scale of movement related fear. Higher scores indicate greater fear.
Time frame
Single measurement at baseline4
Pain Catastrophizing Scale
Likert type patient reported outcome of worry related to pain. HIgher score represent greater worries related to pain.
Time frame
Single assessment at baselineSponsors and contacts
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Source ClinicalTrials.gov
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