The Impact of Dry Needling on Electrophysiological and Ultrasound-based Biomarkers for Myofascial Pain
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Excitability threshold tracking (TT)
研究概览
简要总结
The goal of this interventional study is to determine how well dry-needling can treat pain in people with Myofascial Pain Syndrome. The main questions it aims to answer are:
- Does dry needling improve pain for people with a trigger point (a tender, tight spot in the muscle)?
- How well can Electrical Impedence Myography (EIM), Myofiber Threshold Tracking (TT), and Ultrasound (US) detect changes in the muscle related to dry needling treatment?
Researchers will compare dry needling to a placebo (a treatment that does not enter the trigger point) to see if dry needling works to treat Myofascial Pain Syndrome with trigger points in the trapezius muscle (the muscle that extends over the back of the neck and shoulders), as measured by these three outcome measures (EIM, US, TT).
Participants will:
- Visit the clinic twice: once to receive dry needling treatment, and once for a follow-up
- Have muscle measurements taken before treatment and at follow-up
- Have a daily survey to record the intensity of their pain
详细描述
Pre-Screening:
Participants will be pre-screened to assess eligibility. The questionnaire can be completed on the phone, online in a survey, or in person. Medical records will also be reviewed. Eligible participants will schedule an on-site visit.
Study Visit #1:
In most cases the following sessions will occur on one day, unless due to scheduling conflicts separate sessions must be scheduled.
- Eligibility & Screening: Baseline review of medical history and medication will be done to ensure eligibility. Informed consent will be taken from participants. Demographic data will be taken. This will take approximately one hour.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ages 18-80
- •Presence of active trigger points with involvement of upper trapezius
- •Able to manage breakthrough pain with acetaminophen only, excluding stable doses of pain medications at time of enrollment, which can be continued
排除标准
- •Multiple active trigger points in the trapezius muscle if physician assessment concludes that this may interfere with subject's ability to detect changes in pain improvement from trigger point therapy
- •Presence of cervical radicular pain, superimposed neuromuscular disease or condition that, in the opinion of the investigator, could confound interpretation of the data acquired from trapezius.
- •Fibromyalgia or other generalized pain condition
- •Opioid usage in the past 3 months
- •Active substance use disorder
- •Not on a stable dose for at least two weeks prior to study enrollment or unwilling to maintain a stable dose for duration of the study of the following drugs:
- •SSRIs, such as citalopram, escitalopram, fluoxetine, sertraline,
- •SNRIs, such as duloxetine, milnacipran, and venlafaxine
- •Tricyclic antidepressants, such as notritptyline, amitriptyline, and desipramine
- •Alpha 2 delta ligands: pregabalin, gabapentin
- •Specific anti-epileptics: topiramate, lamotrigine, oxcarbazepine, and phenytoin
- •Other: quinidine, mexiletine, and dalfampridine
- •Skin allergy or sensitivity that would preclude the use of adhesive electrodes
- •Significant systemic or psychiatric illness that in the opinion of the site Investigator would interfere with the individual's ability to participate in the trial
- •Anticoagulation (with coumadin, clopidogrel, or direct oral anticoagulants; aspirin acceptable)
- •TrP needle-based therapy in the past six weeks of the TrP to be studied
- •Body mass index > 35 kg/m2
- •Other factor that in the opinion of the site investigator would interfere with the ability to perform the study procedures
研究组 & 干预措施
Dry Needling Treatment Group
干预措施: Dry Needling (Procedure)
Sham/Placebo Treatment Group
干预措施: Sham Treatment (Procedure)
结局指标
主要结局
Excitability threshold tracking (TT)
时间窗: From enrollment to end of treatment follow up (2 weeks)
The secondary outcome will be maximum latency change with a conditioning stimulus
次要结局
- Muscle ultrasound(From enrollment to end of treatment follow up (approximately 2 weeks))
- Electrical Impedance Myography (EIM)(From enrollment to end of treatment follow up (2 weeks))
- Algometer Measurement Device Output(From enrollment to end of treatment follow up (2 weeks))
研究者
Seward Rutkove
Department of Neurology Chair
Beth Israel Deaconess Medical Center