Does Dry Needling Mediate Cortical Excitability in Patients With Chronic Low Back Pain?
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Short-interval intracortical inhibition
研究概览
简要总结
The investigators plan to use a pre-test post-test research design to investigate whether dry needling (DN) has an effect on cortical excitability in patients with chronic low back pain (CLBP), specifically in patients who have developed central sensitization (CS). Therefore, the primary purpose of this study is to examine the immediate effects of a single session of DN on cortical excitability and neurosensory responses in patients CLBP. There are two specific aims: 1) to examine whether a single session of DN will change cortical excitability corresponding to the lumbar multifidus (LM) muscle, and 2) to examine whether a single session of DN will change neurosensory responses to the stimuli applied to the LM muscles.
The investigators also are interested in exploring whether DN has a differential effect on cortical excitability in patients with CLBP who have developed CS vs. those who have not developed CS. Therefore, the secondary purpose of the study is to compare the immediate effects of a single session of DN on cortical excitability between patients with CLBP who have developed central sensitization (CS) and those who do not have CS. The specific aim is to compare cortical excitability corresponding to the LM in participants with and without CS after a single session of DN.
详细描述
Research Design:
This study will be pre-test post-test trial, in which all eligible participants will receive a single session of dry needling (DN). All outcome measures will be collected before and immediately after a single session of DN.
Procedure:
Eligible participants will be asked to complete an intake form, asking them about their demographic data, including age, gender, height, weight, occupation, past medical history, and questions related to their low back pain (onset, injury mechanism if any, location, duration, type, and nature). Once the participant's eligibility is confirmed, each participant will complete the Central Sensitization Inventory (CSI) questionnaire to assign each participant either in the CS group or non-CS group using the 40 cutoff score of the CSI.
- Clinical Assessments:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults 18-65 years of age
- •Have chronic low back pain primarily in the L4-5 area that has persisted at least 3 months and has resulted in pain on at least half the days in the past 6 months
排除标准
- •Systemic joint disease (e.g. rheumatoid arthritis, psoriasis arthritis)
- •Infection
- •Neurological disorders (e.g., radiculopathy, myelopathy, cauda equina syndrome)
- •Raynaud's disease
- •Pregnancy, previous low back surgery
- •Immunocompromised disease (e.g., diabetes mellitus, HIV, AIDS, lupus)
- •Bleeding disorders (e.g. hemophilia)
- •Use of anti-coagulants (e.g. Coumadin)
- •A history of significant head trauma
- •An electrical, magnetic, or mechanical implantation (e.g. cardiac pacemakers or intracerebral vascular clip)
- •A metal implantation in the head and neck areas,
- •A history of seizures or unexplained loss of consciousness
- •An immediate family member with epilepsy
- •Use of seizure threshold lowering medicine
- •Current abuse of alcohol or drugs
- •A history of psychiatric illness requiring medication controls
- •Inability to maintain the testing and treatment positions (i.e., slightly leaning forward while sitting and prone-lying) for 15 minutes at a time
结局指标
主要结局
Short-interval intracortical inhibition
时间窗: Before and immediately after the intervention
Short-interval intracortical inhibition (%) is a ratio of the amplitude of the conditioned MEP relative to the amplitude of the corresponding test MEP. A subthreshold conditioning (first) TMS at 70% AMT will be delivered 2 ms before a test TMS at a supra-threshold test TMS at 120% AMT.
Intracortical facilitation
时间窗: Before and immediately after the intervention
Intracortical facilitation (%) is a ratio of the amplitude of the conditioned MEP relative to the amplitude of the corresponding test MEP. A subthreshold conditioning (second) TMS at the 90% AMT will be delivered 15 ms after a test (first) TMS at the 100% AMT.
Amplitude of motor evoked potential
时间窗: Before and immediately after the intervention
Amplitude (uV) of motor evoked potential (MEP) will be obtained from the lumbar multifidus muscle during a submaximal contraction (i.e., 20% maximum voluntary isometric contractions) at a stimulus intensity of 130% of active motor threshold (AMT). AMT is defined as the transcranial magnetic stimulation intensity which yields a peak-to-peak amplitude of MEP larger than 200 μV in 5 out of 10 consecutive trials.
次要结局
- Pressure pain threshold(Before and immediately after the intervention)
- Conditioned pain modulation(Before and immediately after the intervention)
研究者
Sharon Wang-Price
Professor
Texas Woman's University