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NCT03686748 · ClinicalTrials.gov registry record · Early Phase 1
Two Point Discrimination
A Early Phase 1 study of Low Back Pain and Fibromyalgia, sponsored by Children's Hospital Medical Center, Cincinnati.
- Active
- Registry status
- Early Phase 1
- Development phase
- 60
- Enrollment target
- 1
- Study location
NCT03686748: Active Early Phase 1 study of Low Back Pain and Fibromyalgia, sponsored by Children's Hospital Medical Center, Cincinnati.
NCT03686748 is a Early Phase 1 study of Low Back Pain and Fibromyalgia that is active but no longer recruiting, run by Children's Hospital Medical Center, Cincinnati. The registered enrollment target is 60 participants, below the 503-participant average among 122 other Low Back Pain trials with a reported enrollment target (88% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03686748, a Early Phase 1 study of Low Back Pain and Fibromyalgia, is active but no longer recruiting, sponsored by Children's Hospital Medical Center, Cincinnati.
- ACTIVE NOT RECRUITING
- Registry status
- Early Phase 1
- Development phase
- 60 participants
- Enrollment target
- 1
- Study location
Study Summary
SPECIFIC AIMS Pain in both youth and adults is a complex, subjective and personal experience, and remains poorly understood. One particularly perplexing dimension of some forms of pain is the tendency of pain to spread outside of an affected body site to adjacent location, and then to unaffected body sites. Such widespread pain may reflect an altered spatial tuning of somatosensory processing, such that lateral inhibition is diminished, thereby allowing pain to spread. To date, no therapies exist which are designed specifically to diminish or even reverse the spatial spread of pain. However, training in two-point discrimination holds the potential to retune spatial aspects of somatosensory processing and may represent a novel therapy for widespread pain. Thus, the present investigation will test the following aims: Aim 1. Do youth with chronic pain have disrupted spatial tuning of somatosensory processing? Deficits in two point tactile discrimination have long been noted in adults with chronic pain, but such deficits remain poorly documented in pediatric chronic pain patients. In order to determine if such deficits exist, youth with both chronic pain and healthy youth will undergo assessment of two point discrimination thresholds. Aim 2. Does two-point discrimination training result in diminished pain and disability in youth with somatic pain? After initial characterization of tactile discrimination thresholds, youth with chronic pain will participate in multiple sessions of either two-point discrimination training or a single-point spatially-directed attentional control condition. Training will involve up to 9 additional sessions. Efficacy of training will be assessed by 1) reductions in the spatial extent of pain, 2) reductions in pain intensity and unpleasantness, and 3) reductions in pain-related disability.
Primary Outcome
total area of body affected by pain
Conditions Studied
Interventions
- BEHAVIORAL Two-point discrimination training
- BEHAVIORAL One-point discrimination training
Study Locations (1)
Ohio
- Cincinnati Children's Hospital Medical Center - Cincinnati
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2018-07-21 |
| Est. Completion | 2027-07-16 |
| Phase | Early Phase 1 |
What the registry record for NCT03686748 still lists
NCT03686748 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 503-participant average among 122 other Low Back Pain trials with a reported enrollment target (88% lower).
The record links to 6 conditions, with Low Back Pain appearing as the primary indexed condition, and to 2 interventions - of which Two-point discrimination training is the first listed.
NCT03686748 reports a single indexed study location in Ohio.
Frequently Asked Questions
What is clinical trial NCT03686748 about?
NCT03686748 is a clinical study titled "Two Point Discrimination". SPECIFIC AIMS Pain in both youth and adults is a complex, subjective and personal experience, and remains poorly understood. One particularly perplexing dimension of some forms of pain is the tendency of pain to spread outside of an affected body site to adjacent location, and then to unaffected bo...
What is the current status of trial NCT03686748?
This trial is currently active not recruiting. It is a Early Phase 1 study. The enrollment target is 60 participants. The study started on 2018-07-21. Estimated completion is 2027-07-16.
What conditions does trial NCT03686748 study?
This clinical trial studies the following conditions: Low Back Pain, Fibromyalgia, Chronic Widespread Pain, Complex Regional Pain Syndrome (CRPS), Ehlers-Danlos Syndrome (EDS).
What interventions are being tested in trial NCT03686748?
The interventions under investigation include: Two-point discrimination training (BEHAVIORAL), One-point discrimination training (BEHAVIORAL).
Who is sponsoring clinical trial NCT03686748?
This trial is sponsored by Children's Hospital Medical Center, Cincinnati, which has 571 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03686748 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03686748's enrollment target sits among peer trials
60 79th of 122 higher than 39 of 122 other Low Back Pain trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Low Back Pain 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.
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