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临床试验/NCT05467098
NCT05467098已完成不适用

Does Dry Needling Change Shoulder Muscle Blood Flow, Motions, and Pain Sensitivity?

Texas Woman's University2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2022年6月30日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
2
主要终点
End Diastolic Velocity (EDV)

研究概览

简要总结

Shoulder pain is one of the most common reasons people consult with their primary health care provider, and 40-50% of these patients with shoulder pain continued to complain of persistent symptoms after 6 to 12 months. It has been suggested that the presence of myofascial trigger points (MTrPs) may contribute to the chronicity of shoulder symptoms. An MTrP is a hyperirritable taut band of tissue within a muscle that produces pain when stimulated MTrPs are common in patients with shoulder disorders and occur most often in the infraspinatus muscle of a painful shoulder MTrPs were associated with an acidic biochemical environment with elevated levels of inflammatory mediators, neuropeptides, and proinflammatory cytokines such as bradykinin and calcitonin g-related peptide. It was hypothesized that metabolic demands on muscle and capillary constrictions may contribute to the development of MTrPs. To date, only a few studies have examined the vascular environment of MTrPs and surrounding areas before and after dry needling. No studies have yet examined whether dry needling would change blood flow in patients with shoulder pathology. Therefore, the purpose of this pilot study is to examine the effect of dry needling on blood flow of the infraspinatus muscle using color Doppler imaging in individuals with and without shoulder pain.

详细描述

RESEARCH DESIGN

The research design for this experimental study will be a repeated measures design. The outcome variables collected in this study are the following: peak systolic velocity, end diastolic velocity, resistive index, pulsatile index, of the infraspinatus, shoulder range of motion (ROM) of internal and external rotations, and Pain pressure threshold (PPT).

PROCEDURE

Eligible participants will be asked to complete an intake form (see Section 6 and 9), asking them about their demographic data, including age, gender, height, weight, occupation, past medical history, and questions related to their shoulder pain (onset, injury mechanism if any, location, duration, type, and nature). The participant's eligibility will be confirmed by the Principal Investigator (PI). Next, each participant will complete the shortened Disabilities of the Arm, Shoulder and Hand Questionnaire (QuickDASH) to determine the participants disability level due to their shoulder pain. After gathering the subjective information and confirming presence of MTrP using palpation, blood flow parameters, shoulder ROMs and PPTs will be collected from the most painful side. If both sides are equally painful, a coin-flip will be used to determine the side of testing. In a subgroup of the first 15 participants in each group, the outcome measures will be assessed twice with a 5-minute break between each measure to establish the reliability prior to the dry needling intervention. The outcome measurements will be administered in an order of shoulder ROMs, followed by PPT and blood flow parameters before the dry needling and in a reverse order of blood flow parameters, PPT and shoulder ROM after dry needling in order to minimize the position changes and to capture immediate changes of blood flow.

SHOULDER RANGE OF MOTION

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
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

入选标准

  • Individuals without shoulder pain:
  • Ages 18-65 and without a history of shoulder pain in the last 12 months
  • absence of a MTrP in the infraspinatus as determined by palpation
  • Individuals with shoulder pain:
  • Ages 18-65 with unilateral nonspecific shoulder pain based on participants' self-reported pain level of greater than or equal to 2/10 on the Numeric Pain Rating Scale (NPRS) in last 24 hours
  • non-traumatic origin of pain
  • presence of at least one MTrP with referral pain pattern in the infraspinatus muscle determined through palpation.

排除标准

  • systemic joint disease (e.g. rheumatoid arthritis)
  • evidence of red flags (e.g. fracture, infection, tumor, cauda equina syndrome)
  • neurological disorders
  • neuropathy
  • Raynaud's disease
  • pregnancy
  • previous shoulder surgery
  • repeated infection
  • immunocompromised disease (e.g., diabetes mellitus, HIV, AIDS, lupus)
  • inability to maintain the testing and treatment positions (i.e., supine and prone-lying) for 15 minutes at a time.
  • bleeding disorders (e.g. hemophilia)
  • use of anti-coagulants (e.g. Coumadin)

结局指标

主要结局

End Diastolic Velocity (EDV)

时间窗: Change from baseline EDV immediately

EDV corresponds to the point marked at the end of the cardiac cycle just prior to the systolic peak.

Resistive Index (RI)

时间窗: Change from baseline RI immediately

Resistive Index is used to assess the resistance in a pulsatile vascular system.The RI is defined by the the formula RI = (PSV - EDV)/PSV.

Peak Systolic Velocity (PSV)

时间窗: Change from baseline PSV immediately

On a Doppler waveform, the PSV corresponds to each "peak" within the spectral window. These values will be used to calculate the RI with the formula RI = (PSV - EDV)/PSV.

Pulsatile Index (PI)

时间窗: Change from baseline PI immediately

Pulsatility index (PI) is defined as the difference between the peak systolic flow and minimum diastolic flow velocity, divided by the mean velocity recorded throughout the cardiac cycle. It is a non-invasive method of assessing vascular resistance with the use of Doppler ultrasonography. PI is defined with the formula PI = (PSV - EDV)/mean velocity, where mean velocity is the average flow velocity during the cardiac cycle.

次要结局

  • Pain Pressure Thresholds(Change from baseline Pain Pressure Threshold immediately)
  • Shoulder Range of Motion(Change from baseline shoulder range of motion immediately)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jace Brown

Principal Investigator

Texas Woman's University

研究点 (2)

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