Feasibility of Near-infrared Spectroscopy to Measure Cortical Pain Pathway (Brain) Activation During Dry Needling
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Change in Muscle Stiffness using the MyotonPro
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(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
排除标准
- •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
结局指标
主要结局
Change in Muscle Stiffness using the MyotonPro
时间窗: 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
时间窗: 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.
次要结局
- Change in Pain Pressure Threshold(Pre-, directly after intervention, and 1 week after intervention)
- Change in Numerical Pain Rating Scale(Pre-, directly after intervention, and 1 week after intervention)
- Movement test(Pre-, directly after intervention, and 1 week after intervention)
- The Global Rate of Change Score(directly after intervention and 1 week after intervention)
- Pain and Shoulder Disability - The Penn Shoulder Score(Pre-,directly after intervention, and 1 week after intervention)