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NCT03445403 · ClinicalTrials.gov registry record · NA
Offset Analgesia as a Measure of Central Sensitization in Children
A NA study, sponsored by Boston Children's Hospital.
- Completed
- Registry status
- NA
- Development phase
- 15
- Enrollment target
NCT03445403: Completed NA study, sponsored by Boston Children's Hospital.
NCT03445403 is a NA study that has completed, run by Boston Children's Hospital. The registered enrollment target is 15 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03445403, a NA study, has completed, sponsored by Boston Children's Hospital.
- COMPLETED
- Registry status
- NA
- Development phase
- 15 participants
- Enrollment target
Study Summary
Pediatric chronic pain disorders are common and consequential in Western societies, occurring in 25-80% of population-based samples with a median prevalence of 11-38% and significant pain-related disability in 3-5% of these children. Pediatric chronic pain disorders have a negative impact on many aspects children's lives including mobility, night sleep, school attendance, peer relationships, family functioning, and overall quality of life. Parents caring for these children risk loss of parental earnings, and these disorders place a high financial burden on healthcare. In a nationally representative sample in the United States, costs related to health care were significantly higher ($1,339 per capita) for children with chronic pain disorders compared to children with common pediatric health conditions of ADHD, asthma and obesity. In children with clinical chronic pain conditions, such as daily headaches or fibromyalgia, chronic pain is presumably a persistent state of an overly excitable nervous system. This phenomenon known as central sensitization is characterized by excessive pain sensitivity that occurs in response to non-painful stimuli, such as light touch or contact with clothing, and slightly painful stimuli, such as a light pinprick. This hypersensitivity results from peculiar changes in the working of the central nervous system, including the spinal cord and brain, and leads to unusual intensification of pain that is out of proportion to the inciting stimulus. For example, light touch from clothing on the skin is perceived as intensely painful. Central sensitization is also thought to contribute to the spreading of pain to other body sites in several chronic pain disorders. In chronic pain disorders, the function of the central descending inhibitory modulating system is likely impaired and is traditionally measured by a phenomenon identified as "conditioned pain modulation (CPM)" and more recently measured by a phenomenon of "offset analgesia" (OA). The O
Primary Outcome
A reduction in self-reported pain intensity when a moderate heat-pain stimulus is applied for 5 seconds, raised by 1 degree C for 5 seconds, reduced by 1 degree C, and held for 20 seconds. During all tests, patients will rate heat pain intensity continuously in real time using the linear, electronic visual analogue scale (eVAS). Patients will use their dominant hand to operate sliding knob of the eVAS with the following two anchors on 0 to 100 mm line. The left endpoint designated as "no pain se
Interventions
- OTHER Offset analgesia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2018-04-01 |
| Est. Completion | 2020-12-01 |
| Phase | NA |
What the finished NCT03445403 record still lists
NCT03445403 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 1 intervention - of which Offset analgesia is the first listed.
NCT03445403 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03445403 about?
NCT03445403 is a clinical study titled "Offset Analgesia as a Measure of Central Sensitization in Children". Pediatric chronic pain disorders are common and consequential in Western societies, occurring in 25-80% of population-based samples with a median prevalence of 11-38% and significant pain-related disability in 3-5% of these children. Pediatric chronic pain disorders have a negative impact on many as...
What is the current status of trial NCT03445403?
This trial is currently completed. It is a NA study. The enrollment target is 15 participants. The study started on 2018-04-01. Estimated completion is 2020-12-01.
What interventions are being tested in trial NCT03445403?
The interventions under investigation include: Offset analgesia (OTHER).
Who is sponsoring clinical trial NCT03445403?
This trial is sponsored by Boston Children's Hospital, which has 462 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03445403's enrollment target sits among peer trials
15 1881st of 2000 higher than 92 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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