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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 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.

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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.

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

FieldValue
Enrollment Target 18 participants
Start Date 2019-01-08
Est. Completion 2020-07-24
Phase Early Phase 1

What the Registry Record Tells You About NCT04170803

The ClinicalTrials.gov registry entry for NCT04170803 describes a study currently listed as completed, categorized as Early Phase 1. The registered enrollment target is 18 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 772-participant average among 301 other Chronic Pain trials with a reported enrollment target (98% lower). The listed sponsor is Army-Baylor University Doctoral Program in Physical Therapy, which has 1 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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