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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Shoulder Pain, Chronic Pain, Musculoskeletal Injury

Intervention / Treatment
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* Device: Dry Needling
* Other: Sham Dry Needling


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This study will be a randomized controlled trial. A convenience sample will be recruited from the Army Medical Department Center and School and the Brooke Army Medical Center (BAMC) Outpatient Physical Therapy Clinic using fliers and word of mouth. A computer-generated table of random numbers will be used to accomplish the group assignment. Thirty participants with shoulder pain will be randomized to receive either true or sham dry needling (Aim #1). An additional 15 participants will be recruited to receive true dry needling (Aim #2). Pre- and post-treatment and 1-week follow-up measurements will be recorded using the MyotonPRO and NIRS, in addition to measures of local hypoalgesia and self-reported pain and disability.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: True Dry Needling<br>Active duty DoD beneficiaries, with shoulder pain will be recruited from Army Medical Department Center and School (AMEDDC&S) and the Brooke Army Medical Center (BAMC) Outpatient Physical Therapy Clinic who meet inclusion and exclusion criteria. The TDN treatment will consist of a trained investigator inserting a needle through the participant's skin, into the infraspinatus muscle using FDA approved (FDA regulation # 880.5580) disposable 0.25 x 40 mm stainless steel Seirin J-type needles (Seirin, Japan). Each shoulder will undergo this treatment. Each needle insertion will last approximately 2-3 seconds using the sparrow pecking (in and out) technique to the depth of the scapula at 3 locations in the infraspinatus muscle on the affected (painful) side. When detectable, the needle insertion will specifically target palpably painful and/or taut bands of tissue. Immediately after use, all needles will be disposed of in approved sharps containers. | Device: Dry Needling<br>* The participant will undergo true or sham dry needling treatment with simultaneous monitoring using the NIRS head cap.<br>* Other names: functional dry needling;|
| Sham Comparator: Sham Dry Needling<br>The sham dry-needling procedure will mimic the dry needling procedures by placing a blunted instrument in a needling guide tube against the skin. The sharp object will be rocked and twisted to simulate treatment, but will not pierce the skin. We have used this sham dry-needling technique in previous studies performed at AMEDDC&S and have found it to be indistinguishable from real dry needling by the great majority of participants.. | Other: Sham Dry Needling<br>* The participant randomized to the sham group will undergo placebo dry needling which is functionally mimicking trigger point dry needling<br>* Other names: Placebo Treatment;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Movement test | The Hawkins-Kennedy Test - shoulder flexion and internal rotation | Pre-, directly after intervention, and 1 week after intervention | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic Pain, Musculoskeletal Injury, Functional near-infrared spectroscopy, Structural health monitoring, Dry needling