Offset Analgesia as a Measure of Central Sensitization in Children
CompletedNot applicableNCT03445403
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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 OA …
Study details
- Official title
- Offset Analgesia as a Measure of Central Sensitization in Children With Chronic Pain Disorders
- Conditions
- Chronic Pain Syndrome
- Chronic Daily Headache
- Functional Abdominal Pain Syndrome
- Musculoskeletal Pain Disorder
- CRPS (Complex Regional Pain Syndromes)
- Interventions
- Other: Offset analgesia
- Sponsor
- Boston Children's Hospital
- Start date
- 2018-04-01
- Primary completion
- 2019-12-27
- Sex
- All
- Age range
- from 10 Years to 17 Years
- Healthy volunteers
- true
- Results posted
- No results posted in this snapshot
- Countries
- United States
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * Patients experiencing chronic pain defined as pain persisting for 3 months. * Ages 10-17 years, both sexes and all races and ethnic groups. * Patients with moderate pain rated as 5/10 and greater on a numeric rating scale of 0 to 10 points. * English speaking. * If patients are taking medications such as psychotropic (e.g., SSRI), opioid, anxiolytics or anticonvulsive drugs for pain such as gabapentinoids, they must be on stable doses for at least one week. * Stable anxiety and depression. Exclusion Criteria: * Intermittent pain or pain of less than 3-month duration. * Allodynia in the upper extremities * Patients with poor understanding of English language or developmental disorders that affect the ability to reliably rate pain, read questionnaires and follow study instructions. * Children and adolescents with a history of central nervous system, heart, kidney, liver, and respiratory system diseases. * Psychiatric disorders such as conversion, bipolar disorder or psychosis.
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT03445403