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

Chronic Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04170803
• Other study ID #: C.2018.057d
• Secondary ID: 40037-0010-0001-
• Status: Completed
• Phase: Early Phase 1
• Start date: January 8, 2019
• Est. completion date: July 24, 2020

Study information

• Verified date: July 2020
• Source: Army-Baylor University Doctoral Program in Physical Therapy
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

This study supports a line of ongoing investigation aimed at improving the diagnosis, management, and treatment of chronic pain after musculoskeletal injury. Continued progress in this arena requires novel methods to measure central nervous system (brain) mechanism of action and its role in identification of the unique transition of musculoskeletal injury to chronic pain. The purpose of this study is to use near-infrared spectroscopy (NIRS) to measure changes along cortical pain pathways in the brain related to true and sham dry needling treatment.

Specific Aim #1: The investigators will compare the cortical pain pathway response during dry needling treatment to sham dry needling treatment using NIRS in two groups of patients with chronic shoulder pain.

The investigators hypothesize that decreased cortical activity will be seen in the dorsolateral prefrontal cortex (DLPFC) in those treated with true dry needling compared to those treated with sham dry needling.

Specific Aim #2: The investigators will evaluate whether the cortical pain pathway response (imaged using NIRS) during dry needling predicts 1-week improvement in shoulder muscle response, local hypoalgesia, and self-reported pain and disability in the group of patients that received true dry needling treatment. The investigators hypothesize that decreased cortical activity in the DLPFC will be associated with improvements in shoulder muscle response, local hypoalgesia, and self-reported pain and disability in those treated with true dry needling.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: July 24, 2020
• Est. primary completion date: July 9, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

(all of the following) Active duty DoD beneficiary Age 18-50 years old Non-traumatic shoulder pain rated at least 4/10 on the Numeric Pain Rating Scale Right-handed

Exclusion Criteria:

• Anticoagulant medication use Bleeding disorders Shoulder pain referred from cervical spine Full-thickness rotator cuff tears Known pregnancy Inability to lie prone Left- or mixed-handed

Related Conditions & MeSH terms

• Chronic Pain
• Musculoskeletal Injury
• Shoulder Pain

Intervention

Device:
• Dry Needling
The participant will undergo true or sham dry needling treatment with simultaneous monitoring using the NIRS head cap.

Other:
• Sham Dry Needling
The participant randomized to the "sham" group will undergo placebo dry needling which is functionally mimicking trigger point dry needling

Locations

Country	Name	City	State
United States	Army Medical Department Center and Schools, Ft Sam Houston	San Antonio	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Army-Baylor University Doctoral Program in Physical Therapy	Brooke Army Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (26)

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Boyles R, Fowler R, Ramsey D, Burrows E. Effectiveness of trigger point dry needling for multiple body regions: a systematic review. J Man Manip Ther. 2015 Dec;23(5):276-93. doi: 10.1179/2042618615Y.0000000014. — View Citation

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* Note: There are 26 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Functional Near-Infrared Spectroscopy	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 (absorption) and then the modified Beer-Lambert law will be applied to convert the data from optical density to change in oxy- and deoxyhemoglobin concentration.	Pre-, During intervention (real-time for approximately 3-5 minutes), directly after intervention, 1 week after intervention
Primary	Change in Muscle Stiffness using the MyotonPro	the MyotonPRO, a research only device, (Myoton AS, Tallinn, Estonia) by applying a mechanical impulse to the skin, which is transmitted to the underlying soft tissue and muscle (0.58 N for 15 ms). 33 The oscillation of the muscle is recorded by an accelerometer located at the probe end. Measures will be taken at the same three locations in each infraspinatus muscle as the dry needling.	Pre-, directly after intervention, and 1 week after intervention
Secondary	Movement test	The Hawkins-Kennedy Test - shoulder flexion and internal rotation	Pre-, directly after intervention, and 1 week after intervention
Secondary	Change in Pain Pressure Threshold	is the minimal amount of pressure that produces pain and is used to assess abnormalities in nociceptive processing or hyperalgisia.34 We will use a digital pressure algometer (Wagner Force 25 FDX, Wagner Instruments, Greenwich, CT) to measure PPT, and will operationally define it as the minimal amount of pressure that produces pain or discomfort. Pressure algometry has been found to be highly reliable, especially when using the same rater (ICC=0.94-.097)	Pre-, directly after intervention, and 1 week after intervention
Secondary	The Global Rate of Change Score	The GRC assesses subjective perception of overall change on a 15-point Likert type scale ranging from 1 (very great deal worse) to 15 (a very great deal better).38	directly after intervention and 1 week after intervention
Secondary	Change in Numerical Pain Rating Scale	will also be used to quantify clinical changes in pain. Pain during a comparable sign39 will be additionally assessed at baseline, immediately after needling, and during the follow up visit. Participants will report a simple physical maneuver that could reproduce their primary shoulder symptoms, such as shoulder flexion with internal rotation or the Hawkins-Kennedy test. Participants will then be asked to perform this maneuver and report their pain intensity using an 11-point NPRS from 0 to 10. Previous work has reported the MCID of the NPRS in patients with shoulder pain to be 1.1 points.	Pre-, directly after intervention, and 1 week after intervention
Secondary	Pain and Shoulder Disability - The Penn Shoulder Score	: The Penn Shoulder Score will be used as the primary measure of clinical outcome. This 100-point shoulder-specific self-report questionnaire consists of 3 subscales of pain, satisfaction, and function. A maximum score of 100 indicates no disability, no pain, and high satisfaction with the function of the shoulder. When aggregated, the questionnaire has demonstrated high test-retest reliability (ICC=0.94), internally consistency (Cronbach alpha = 0.93), and responsiveness in patients with shoulder pain. The minimal clinically important difference (MCID) for improvement has been reported at 11.4 points.37	Pre-,directly after intervention, and 1 week after intervention