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NCT04170803 · ClinicalTrials.gov registry record · Early Phase 1
Feasibility of Near-infrared Spectroscopy to Measure Cortical Pain Pathway (Brain) Activation During Dry Needling
A Early Phase 1 study of Chronic Pain and Shoulder Pain, sponsored by Army-Baylor University Doctoral Program in Physical Therapy.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 18
- Enrollment target
- 1
- Study location
NCT04170803: Completed Early Phase 1 study of Chronic Pain and Shoulder Pain, sponsored by Army-Baylor University Doctoral Program in Physical Therapy.
NCT04170803 is a Early Phase 1 study of Chronic Pain and Shoulder Pain that has completed, run by Army-Baylor University Doctoral Program in Physical Therapy. The registered enrollment target is 18 participants, below the 772-participant average among 301 other Chronic Pain trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04170803, a Early Phase 1 study of Chronic Pain and Shoulder Pain, has completed, sponsored by Army-Baylor University Doctoral Program in Physical Therapy.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 18 participants
- Enrollment target
- 1
- Study location
Study Summary
The benefit experienced by some patients when treated with dry needling,1 combined with the field-expedient nature of this intervention, make dry needling uniquely suited for the military healthcare environment. An improved understanding of the mechanism by which dry needling exerts its clinical benefits will allow clinicians to adopt more efficacious treatment strategies for Soldiers with chronic musculoskeletal pain. The proposed study will utilize functional near-infrared spectroscopy and structural health monitoring (SHM) to provide insight on the central and peripheral mechanisms of dry needling. Phase 1 will compare the cortical pain pathway response of thirty participants with non-traumatic shoulder pain receiving either true or sham dry needling. An additional 15 participants will be enrolled to receive true dry needling to determine if brain responses may be able to predict clinical improvement (responders versus non-responders) in phase 2. Since chronic pain after musculoskeletal injury is the leading cause of medical discharge from service and a primary source of disability in the U.S. military2,3, improved complementary and alternative treatment strategies have the potential to have a large impact on both military readiness and health care costs within the Armed Forces.
Primary Outcome
NIRS is a technology that uses low levels (less than 4mW/mm2 at 800nm) of non-ionizing, near-infrared, diffuse light to measure spectroscopic absorption changes. It will be used to non-invasively measures hemodynamic changes in the brain. An 8-channel NIRS instrument will be used to measure changes in the intensity of visible red to near-infrared light (760 and 850 nm) between sources and detectors that are placed on the scalp. Changes in intensity will be converted to optical density (absorptio
Conditions Studied
Interventions
- DEVICE Dry Needling
- OTHER Sham Dry Needling
Study Locations (1)
Texas
- Army Medical Department Center and Schools, Ft Sam Houston - San Antonio
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2019-01-08 |
| Est. Completion | 2020-07-24 |
| Phase | Early Phase 1 |
What the finished NCT04170803 record still lists
NCT04170803 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 772-participant average among 301 other Chronic Pain trials with a reported enrollment target (98% lower).
The record links to 3 conditions, with Chronic Pain appearing as the primary indexed condition, and to 2 interventions - of which Dry Needling is the first listed.
NCT04170803 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT04170803 about?
NCT04170803 is a clinical study titled "Feasibility of Near-infrared Spectroscopy to Measure Cortical Pain Pathway (Brain) Activation During Dry Needling". The benefit experienced by some patients when treated with dry needling,1 combined with the field-expedient nature of this intervention, make dry needling uniquely suited for the military healthcare environment. An improved understanding of the mechanism by which dry needling exerts its clinical ben...
What is the current status of trial NCT04170803?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 18 participants. The study started on 2019-01-08. Estimated completion is 2020-07-24.
What conditions does trial NCT04170803 study?
This clinical trial studies the following conditions: Chronic Pain, Shoulder Pain, Musculoskeletal Injury.
What interventions are being tested in trial NCT04170803?
The interventions under investigation include: Dry Needling (DEVICE), Sham Dry Needling (OTHER).
Who is sponsoring clinical trial NCT04170803?
This trial is sponsored by Army-Baylor University Doctoral Program in Physical Therapy, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04170803 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04170803's enrollment target sits among peer trials
18 278th of 301 higher than 23 of 301 other Chronic Pain trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Chronic 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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