CI

At a glance

ClinicalIndex Comparison Record
Early Ph 1Completed· 18 enrolled
Drug / intervention
Dry Needling +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04170803
NCT04170803Early Ph 1Completed

Feasibility of Near-infrared Spectroscopy to Measure Cortical Pain Pathway (Brain) Activation During Dry Needling

Army-Baylor University Doctoral Program in Physical Therapy·interventional·Posted Nov 20, 2019·Updated Jul 28, 2020

In Brief

A Early Phase 1 clinical trial evaluating Dry Needling and Sham Dry Needling for Shoulder Pain and 2 related conditions. Completed, enrolled 18 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Early Ph 1CompletedFinished
20192020202120222023202420252026
First PostedNov 20, 2019
Enrollment StartJan 8, 2019
Primary CompletionJul 9, 2019
Study CompletionJul 24, 2020
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 6.6 years ago

Interventions

Dry Needlingdevice

The participant will undergo true or sham dry needling treatment with simultaneous monitoring using the NIRS head cap.

Sham Dry Needlingother

The participant randomized to the "sham" group will undergo placebo dry needling which is functionally mimicking trigger point dry needling