Texas Woman's University T. Boone Pickens Institute of Health Sciences
Dallas, Texas, 75235, United States
NCT Number: NCT06705634
Segmental facilitation, originally proposed by Korr in the 1950s, suggests that certain spinal segments can become hyperexcitable, leading to chronic pain development. In a facilitated segment, neurons governing sensory, motor, and autonomic functions are in a state of heightened sensitivity, making them responsive to normally weak stimuli. Clinical signs include non-fatigable muscle weakness, brisk reflexes, muscle hypertonicity, tenderness upon palpation, and trophic changes like an orange-peel appearance in the affected segment's innervated areas. It's hypothesized that increased synaptic excitability in facilitated segments could cause vasoconstriction and reduced blood flow, contributing to trophic changes and muscle hypertonicity.
Manual therapies like dry needling have been shown to alleviate muscle inhibition in the extremities. Previous studies have demonstrated that mobilization of the C5-6 joint can reduce non-fatigable weakness in shoulder external rotators primarily innervated by these segments. However, the neurophysiological effects of dry needling (DN) on muscle inhibition due to a facilitated segment remain unclear. While DN has been observed to increase local tissue blood flow, its potential to mitigate the clinical signs of segmental facilitation is uncertain. While DN has been observed to increase local tissue blood flow, its potential to mitigate the clinical signs of segmental facilitation is uncertain.
Therefore, this project aims to investigate whether DN applied at a facilitated segment could normalize blood flow to its associated muscles. Specifically, this study will explore whether DN at the C5-6 level improves blood flow in the infraspinatus muscle, enhances shoulder range of motion, and influences muscle strength over time. The secondary purpose is to determine whether C5-6 DN will reduce the number of tender points in the muscles supplied by C5-6.
This study is active but is not currently recruiting participants.
18 year–65 year
All sexes
Interventional
Not applicable
Dallas, Texas, 75235, United States
All participants are required to attend 1 on-site visit (~ 1.25-1.5 hours) at the study site (TWU). The procedures of this research study are described in the following:
At the beginning of the on-site visit, one investigator, depending on the study site and availability of the investigators, will describe the study purpose/procedures as well as the risks/benefits associated with this study to each participant. Once the participant agrees to participate in this study, the participant will be asked to sign the written consent form. Next, the participant will complete an intake form (see below and Section 9) for their demographic information and the history of their neck-shoulder pain. Each participant also will complete 3 questionnaires: (1) Brief Pain Index (BPI), (2) Quick Disability of Arm, Shoulder, and Hand Questionnaire (QuickDASH), and (3) Central Sensitization Inventory (CSI). These forms will be delivered online via Google form, or on paper if the participant prefers. These 3 questionnaires will provide information on each participant's neck-shoulder pain, function level, and degree of central sensitization/segmental facilitation.
The BPI (see Section 9) is a 9-item self-administered questionnaire used to evaluate the severity of a patient's pain and the impact of this pain on the patient's daily functioning. The QuickDash is a self-report questionnaire (see Section 9) used to determine how shoulder pain affects a patient's daily life and to assess the self-rated disability of patients with shoulder pain. The CSI consists of two parts: Part A is a 25-item self-report questionnaire designed to identify patients who have symptoms that may be related to central sensitization. Part B asks patients whether they have been diagnosed with 10 central sensitization syndromes, such as fibromyalgia, whiplash, and migraine.
During this palpation assessment, the participants will lie prone with their arms at their sides. The investigator will palpate for tender points at the following muscle groups innervated by C5-C6 to determine eligibility: (1) Cervical paraspinals at C5-6 segment, (2) rhomboids near the spine of the scapula, (3) supraspinatus muscle belly, (4) the middle of the infraspinatus muscle belly, (5) middle deltoid. A skin marker will be used to mark these 4 sites so that the investigator can assess the same locations during the re-assessments.
After gathering the subjective information and confirming the eligibility of the participant, the 3 outcome measures will be collected. The outcome measures will be collected in the following order to minimize position changes that could impact blood flow: (1) blood flow parameters in prone, (2) Shoulder range of motion (ROM), (3) Shoulder external rotation strength in supine.
Following the baseline testing, the PI (JB) or Co-PI (SWP) will perform the dry needling intervention. All three have more than 10 years of experience with dry needling. A sterile, disposable, solid filament needle (Seirin Corp., Shizuoka, Japan) will be inserted manually into the multifidus of C5-C6 on each side of the segment. Once the needle has been inserted, the needle will be pistoned in an up-and-down motion within the multifidus muscle at approximately 1Hz for 10 seconds. The needles will then be left in-situ for 5 minutes.
Cadaveric and Ultrasonographic Validation of Needling Placement in the Cervical Multifidus Muscle - ScienceDirect
The 4 outcome measures will be assessed in the following order to minimize position changes: (1) blood flow parameters in the prone, (2) shoulder range of motions, (3) the number of tender points in the prone position, and then (4) Shoulder ER strength in the supine position. Shoulder ER strength will be assessed 3 times: Immediately, 15 minutes, and 30 minutes after the intervention.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants will be excluded from this study if they have a contraindication to dry needling or a medical condition affecting blood flow, including but not limited to:
A sterile, disposable, solid filament needle (Seirin Corp., Shizuoka, Japan) will be inserted manually into the multifidus of the C5-C6 cervical muscles. Once the needle has been inserted, the needle will be pistoned in an up and down motion within the multifidus muscle at approximately 1Hz for 10 seconds and then left in-situ for 5 minutes.
Time frame: Change from baseline immediately following the intervention
On a Doppler waveform, the Peak Systolic Velocity corresponds to each "peak" within the spectral window.
Time frame: Change from baseline immediately following the intervention
End Diastolic Velocity (EDV) EDV corresponds to the point marked at the end of the cardiac cycle just prior to the systolic peak.
Time frame: Change from baseline immediately following the intervention
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.
Time frame: Change from baseline immediately following the intervention
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.
Time frame: Change from baseline immediately following the intervention
Shoulder range of motion of internal and external rotation is the number of degrees of motion measured using standard goniometry.
Time frame: Change from baseline immediately following the intervention, 15 minutes after the intervention, 30 minutes after the intervention
Shoulder external rotation strength will be measured in Newtons using a handheld dynamometer at baseline and post-intervention to assess the effect of dry needling.
Time frame: Change from baseline immediately following the intervention
The number of tender points will be assessed during palpation of muscle groups innervated by C5-C6, including the cervical paraspinals (C5-6 segment), rhomboids (near the spine of the scapula), supraspinatus muscle belly, middle of the infraspinatus muscle belly, and middle deltoid.
Texas Woman's University
Other
Effects of Dry Needling of C5-C6 on Shoulder Range of Motion, Strength, Tender Points, and Blood Flow
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