Feasibility of Near-infrared Spectroscopy to Measure Cortical Pain Pathway (Brain) Activation During Dry Needling
- Conditions
- Shoulder PainChronic PainMusculoskeletal Injury
- Interventions
- Device: Dry NeedlingOther: Sham Dry Needling
- Registration Number
- NCT04170803
- Lead Sponsor
- Army-Baylor University Doctoral Program in Physical Therapy
- Brief 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.
- Detailed 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 & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 18
(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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description True Dry Needling Dry Needling 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. Sham Dry Needling Sham Dry Needling 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..
- Primary Outcome Measures
Name Time Method Change in Muscle Stiffness using the MyotonPro Pre-, directly after intervention, and 1 week after intervention 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.
Change in Functional Near-Infrared Spectroscopy Pre-, During intervention (real-time for approximately 3-5 minutes), directly after intervention, 1 week after intervention 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.
- Secondary Outcome Measures
Name Time Method Change in Pain Pressure Threshold Pre-, directly after intervention, and 1 week after intervention 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)
Change in Numerical Pain Rating Scale Pre-, directly after intervention, and 1 week after intervention 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.
Movement test Pre-, directly after intervention, and 1 week after intervention The Hawkins-Kennedy Test - shoulder flexion and internal rotation
The Global Rate of Change Score directly after intervention and 1 week after intervention 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
Pain and Shoulder Disability - The Penn Shoulder Score Pre-,directly after intervention, and 1 week after intervention : 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
Trial Locations
- Locations (1)
Army Medical Department Center and Schools, Ft Sam Houston
🇺🇸San Antonio, Texas, United States