The Effects of Dry Needling on Muscle Blood Flow of the Infraspinatus in Individuals with Shoulder Pain - a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 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 shoulder pain. The secondary purpose is to examine the effect of DN on shoulder motion and sensitivity to pressure in individuals with shoulder pain.
详细描述
RESEARCH DESIGN This pilot study will be a single-blinded randomized comparison trial with two groups: (1) the group that will receive real DN, and (2) a placebo group that will receive sham DN. The research design will be a prospective two-way (2 x 2) mixed design to examine the effects of DN on blood flow (i.e., peak systolic velocity, end diastolic velocity, resistive index, pulsatile index) of the infraspinatus, shoulder range of motionss of internal rotation and external rotation, and PPTs of the infraspinatus. The two independent variables are: (1) group with two levels (DN and sham DN groups), and (2) time with two levels (baseline and immediately after the intervention) for the peak systolic velocity, end diastolic velocity, resistive index, pulsatile index of the infraspinatus, shoulder internal rotation, shoulder external rotation, and PPTS of the infraspinatus.
INSTRUMENTATION A color-Doppler ultrasonographic scanner and a curvilinear transducer (Sonosite Edge; Sonosite, Inc., Bothell, WA) will be used to measure blood flow of the infraspinatus muscle. The curvilinear probe (5-2MHz) has ability to capture images up to 30 cm in depth. A standard goniometer with 1° increments will be used to measure shoulder ROMs. Standard goniometric measurements have shown good-to-excellent reliability for shoulder internal and external ROMs.23 A hand-held computerized pressure algometer (Medoc ltd., Ramat Yishai, Israel) will be used to measure the PPT over the infraspinatus muscle. The algometer consists of a 1 cm2 round-tip that will be pressed perpendicular to the skin of the infraspinatus muscle at a rate of 40kPa/s until the first perception of pain or discomfort detected by the participant. The participant will be able to stop the test with a press of a button upon feeling the first sensation of pain or discomfort. This device has shown to have high test-retest reliability (intraclass correlation coefficients = 0.70-0.94) in the shoulder and neck muscles.
PROCEDURE At the beginning of the visit, all participants will be asked for demographic information and their pain-related characteristics, including location, duration, intensity at onset, and intensity currently, at best, and at worst in the previous 24-hours using the NPRS. After the subjective information is gathered, an investigator will assess for the presence of MTrP based on palpation. The participant will be placed in the prone position with arms resting at their side. The examiner will palpate the infraspinatus muscle belly for the presence of a taut band, a hypersensitive spot, and reproduction of the participants symptoms.11 Al-Shenqiti and Oldham25 demonstrated high reliability (k=0.86) with palpation for the presence or absence of the taut band, spot tenderness, and/or referred pain sensation.
Once the participant is determined eligible, they will be asked to complete the Quick Disability of Arm Shoulder Hand (QuickDASH) questionnaire to determine their self-reported disability and function (Appendix C).26 Next, the three outcome measures will be collected, including blood flow parameters, shoulder ROMs, and PPTs. If the participant has bilateral shoulder pain, the most painful shoulder will be tested. If both shoulders are equally painful, a coin-flip will be used to determine the side on which testing will be performed. The outcome measurements will be administered in an order of shoulder ROMs, followed by PPT and blood flow parameters before the DN intervention. Following the intervention, the outcome measurements will be collected in a reverse order of blood flow parameters, PPT, and shoulder ROM to minimize the position changes and to capture immediate changes of blood flow. These outcomes will be assessed by an investigator blinded to the intervention assignment.
SHOULDER RANGE OF MOTION ROM testing will be performed while the participant is lying supine with the shoulder at 90° abduction and 10° of horizontal abduction and elbow at 90°flexion. The examiner will be responsible for all the measurements. The center of rotation of the goniometer will be placed over the olecranon while one arm of the goniometer will be positioned along the length of the ulna, aligned with the ulnar styloid process. The other arm will be positioned perpendicular to the ground. For both measurement of internal and external rotation, scapular compensation will be monitored by using the thumb on the coracoid process and fingers along the spine of the scapula. Each measurement will be repeated three times with the average measurements used for data analysis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
The participant will not be told whether they are assigned to the interventional or sham group. The outcomes (blood flow, pain pressure threshold, and range of motion) will be assessed by an investigator blinded to the intervention assignment.
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
- •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. signs of current fracture or history of fracture to scapula, glenoid or proximal humerus, infection, tumor, incontinence, or paresthesias)
- •neurological disorders
- •neuropathy
- •Raynaud's disease
- •pregnancy
- •previous shoulder surgery
- •repeated infection (e.g. systemic infection, red skin, fever, individuals who are visibly unwell or toxic in appearance)
- •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. vitamin K antagonists, direct oral anticoagulants, and low molecular weight heparins)
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.
Peak Systolic Velocity
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.
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.
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 (PPT)(Change from baseline PPT immediately)
- Shoulder Range of Motion(Change from baseline shoulder range of motion immediately)
研究者
Jace Brown
Principal Investigator
Texas Woman's University